Bile Duct Injury Management Early Vs Delayed Repair

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					5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC              Proposed AE Term                 Proposed Grade 1                        Proposed Grade 2




                                                                                                                             Moderate; minimal, local or
                                                                                     Asymptomatic or mild symptoms;          noninvasive intervention indicated;
Lymphatics - Other (Specify,      Blood and lymphatic   Blood and lymphatic -        clinical or diagnostic observations     limiting age-appropriate
__)                               system disorders      Other, specify               only; intervention not indicated        instrumental ADL
                                                                                     Mildly hypocellular or <=25%            Moderately hypocellular or >25 -
                                  Blood and lymphatic                                reduction from normal cellularity       <=50% reduction from normal
Bone marrow cellularity           system disorders      Bone marrow hypocellular     for age                                 cellularity for age

DIC (disseminated                 Blood and lymphatic   Disseminated intravascular                                           Laboratory findings with no
intravascular coagulation)        system disorders      coagulation                                     -                    bleeding



Febrile neutropenia (fever of
unknown origin without
clinically or microbiologically
documented infection)(ANC
<1.0 x 10e9/L, fever >=38.5       Blood and lymphatic
degrees C)                        system disorders      Febrile neutropenia                             -                                     -

                                                                                     Laboratory evidence of hemolysis
Hemolysis (e.g., immune                                                              only (e.g., direct antiglobulin test;   Evidence of red cell destruction
hemolytic anemia, drug-           Blood and lymphatic                                DAT; Coombs'; schistocytes;             and >=2 gm decrease in
related hemolysis)                system disorders      Hemolysis                    decreased haptoglobin)                  hemoglobin, no transfusion


Thrombotic microangiopathy
(e.g., thrombotic
thrombocytopenic purpura                                                          Evidence of RBC destruction
[TTP] or hemolytic uremic         Blood and lymphatic                             (schistocytosis) without clinical
syndrome [HUS])                   system disorders      Hemolytic uremic syndrome consequences                                                -



                                  Blood and lymphatic
Leukocytes (total WBC)            system disorders      Leukocytosis                                -                                         -
                                  Blood and lymphatic                                <LLN - 3000/mm(3) <LLN - 3.0 x          <3000 - 2000/mm(3) <3.0 - 2.0 x
Leukocytes (total WBC)            system disorders      Leukopenia                   10e9 /L                                 10e9 /L
                                  Blood and lymphatic                                                                        Moderate pain; limiting
Pain Lymph node                   system disorders      Lymph node pain              Mild pain                               instrumental ADL
                                  Blood and lymphatic
Lymphopenia                       system disorders      Lymphocytosis                               -                        >4000/uL
                                  Blood and lymphatic                                <LLN - 800/mm(3) <LLN x 0.8 -           <800 - 500/mm(3) <0.8 - 0.5 x
Lymphopenia                       system disorders      Lymphopenia                  10e9 /L                                 10e9 /L




1                                                                                                                                                                  1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC              Proposed AE Term                  Proposed Grade 1                     Proposed Grade 2
Neutrophils/granulocytes         Blood and lymphatic                                  <LLN - 1500/mm(3) <LLN - 1.5 x       <1500 - 1000/mm(3) <1.5 - 1.0 x
(ANC/AGC)                        system disorders      Neutropenia                    10e9 /L                              10e9 /L

                                                                                      Incidental findings (e.g., Howell-
                                 Blood and lymphatic                                  Jolly bodies); mild degree of
Splenic function                 system disorders      Spleen disorder                thrombocytosis and leukocytosis      Prophylactic antibiotics indicated
                                 Blood and lymphatic                                  <LLN - 75,000/mm(3) <LLN - 75.0      <75,000 - 50,000/mm(3) <75.0 -
Platelets                        system disorders      Thrombocytopenia               x 10e9 /L                            50.0 x 10e9 /L


Thrombotic microangiopathy
(e.g., thrombotic
thrombocytopenic purpura                                                              Evidence of RBC destruction
[TTP] or hemolytic uremic        Blood and lymphatic   Thrombotic                     (schistocytosis) without clinical
syndrome [HUS])                  system disorders      thrombocytopenic purpura       consequences                                           -



                                                                                                                           Symptomatic, progressive angina;
                                                                                                                           cardiac enzymes normal;
Cardiac ischemia/infarction      Cardiac disorders     Acute coronary syndrome                          -                  hemodynamically stable



                                                                                      Asymptomatic valvular thickening     Asymptomatic; moderate
                                                                                      with or without mild valvular        regurgitation or stenosis by
Valvular heart disease           Cardiac disorders     Aortic valve disease           regurgitation or stenosis            imaging
Conduction
abnormality/atrioventricular
heart block Asystole             Cardiac disorders     Asystole                                         -                                    -



Supraventricular and nodal                                                            Asymptomatic, intervention not       Non-urgent medical intervention
arrhythmia Atrial fibrillation   Cardiac disorders     Atrial fibrillation            indicated                            indicated



Supraventricular and nodal                                                            Asymptomatic, intervention not       Non-urgent medical intervention
arrhythmia Atrial flutter        Cardiac disorders     Atrial flutter                 indicated                            indicated

Conduction
abnormality/atrioventricular
heart block AV Block-Third                             Atrioventricular block
degree (Complete AV block)       Cardiac disorders     complete                                         -                  Non-urgent intervention indicated
Conduction
abnormality/atrioventricular
heart block AV Block-First                             Atrioventricular block first   Asymptomatic, intervention not
degree                           Cardiac disorders     degree                         indicated                            Non-urgent intervention indicated




2                                                                                                                                                               1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                    SOC            Proposed AE Term                Proposed Grade 1                      Proposed Grade 2
Conduction
abnormality/atrioventricular
heart block Asystole           Cardiac disorders   Cardiac arrest                                 -                                    -




                                                                                                                      Moderate; minimal, local or
                                                                                Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Cardiac Arrhythmia - Other                         Cardiac disorders - Other,   clinical or diagnostic observations   limiting age-appropriate
(Specify, __)                  Cardiac disorders   specify                      only; intervention not indicated      instrumental ADL
                                                                                                                      Moderate pain; limiting
Pain Cardiac/heart             Cardiac disorders   Chest pain - cardiac         Mild pain                             instrumental ADL
Conduction
abnormality/atrioventricular
heart block Conduction                                                          Mild symptoms; intervention not
abnormality NOS                Cardiac disorders   Conduction disorder          indicated                             Moderate symptoms



Restrictive cardiomyopathy     Cardiac disorders   Constrictive pericarditis                      -                                    -




                                                                                Asymptomatic with laboratory
Left ventricular diastolic                                                      (e.g., BNP [B-Natriuretic Peptide ]) Symptoms with mild to moderate
dysfunction                    Cardiac disorders   Heart failure                or cardiac imaging abnormalities     activity or exertion




                                                                                Asymptomatic with laboratory
Left ventricular systolic                                                       (e.g., BNP [B-Natriuretic Peptide ]) Symptoms with mild to moderate
dysfunction                    Cardiac disorders   Left ventricular failure     or cardiac imaging abnormalities     activity or exertion



                                                                                Asymptomatic valvular thickening      Asymptomatic; moderate
                                                                                with or without mild valvular         regurgitation or stenosis by
Valvular heart disease         Cardiac disorders   Mitral valve disease         regurgitation or stenosis             imaging

Conduction
abnormality/atrioventricular
heart block AV Block-Second                        Mobitz (type) II                                                   Symptomatic; medical intervention
degree Mobitz Type II          Cardiac disorders   atrioventricular block                         -                   indicated




3                                                                                                                                                           1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC           Proposed AE Term                Proposed Grade 1                    Proposed Grade 2
Conduction
abnormality/atrioventricular
heart block AV Block-Second
degree Mobitz Type I                                                             Asymptomatic, intervention not     Symptomatic; medical intervention
(Wenckebach)                    Cardiac disorders   Mobitz type I                indicated                          indicated

                                                                                                                    Asymptomatic and cardiac
                                                                                                                    enzymes minimally abnormal and
                                                                                                                    no evidence of ischemic ECG
Cardiac ischemia/infarction     Cardiac disorders   Myocardial infarction                        -                  changes.




                                                                                 Asymptomatic with laboratory
                                                                                 (e.g., BNP [B-Natriuretic Peptide ]) Symptoms with mild to moderate
Myocarditis                     Cardiac disorders   Myocarditis                  or cardiac imaging abnormalities     activity or exertion
                                                                                 Mild symptoms; intervention not
Palpitations                    Cardiac disorders   Palpitations                 indicated                            Intervention indicated
Supraventricular and nodal
arrhythmia Atrial
tachycardia/Paroxysmal Atrial                       Paroxysmal atrial            Asymptomatic, intervention not     Symptomatic; medical intervention
Tachycardia                     Cardiac disorders   tachycardia                  indicated                          indicated

Pericardial effusion (non-                                                                                          Asymptomatic effusion size small
malignant)                      Cardiac disorders   Pericardial effusion                         -                  to moderate

Pericardial effusion (non-
malignant)                      Cardiac disorders   Pericardial tamponade                        -                                   -

                                                                                 Asymptomatic, ECG or physical
                                                                                 exam (e.g., rub) findings          Symptomatic pericarditis (e.g.,
Pericarditis                    Cardiac disorders   Pericarditis                 consistent with pericarditis       chest pain)



                                                                                 Asymptomatic valvular thickening   Symptomatic; severe regurgitation
                                                                                 with or without mild valvular      or stenosis; symptoms controlled
Valvular heart disease          Cardiac disorders   Pulmonary valve disease      regurgitation or stenosis          with medical intervention



Restrictive cardiomyopathy      Cardiac disorders   Restrictive cardiomyopathy                   -                                   -



                                                                                 Asymptomatic with laboratory
Right ventricular dysfunction                       Right ventricular            (e.g., BNP [B-Natriuretic Peptide ]) Symptoms with mild to moderate
(cor pulmonale)                 Cardiac disorders   dysfunction                  or cardiac imaging abnormalities     activity or exertion



4                                                                                                                                                       1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                    SOC                   Proposed AE Term                Proposed Grade 1                      Proposed Grade 2
Conduction
abnormality/atrioventricular
heart block Sick Sinus                                                                 Asymptomatic, intervention not
Syndrome                       Cardiac disorders          Sick sinus syndrome          indicated                             Non-urgent intervention indicated

Supraventricular and nodal                                                             Asymptomatic, intervention not        Symptomatic; medical intervention
arrhythmia Sinus bradycardia   Cardiac disorders          Sinus bradycardia            indicated                             indicated

Supraventricular and nodal                                                             Asymptomatic, intervention not        Symptomatic; medical intervention
arrhythmia Sinus tachycardia   Cardiac disorders          Sinus tachycardia            indicated                             indicated

Supraventricular and nodal
arrhythmia Supraventricular                               Supraventricular             Asymptomatic, intervention not        Non-urgent medical intervention
tachycardia                    Cardiac disorders          tachycardia                  indicated                             indicated



                                                                                       Asymptomatic valvular thickening      Asymptomatic; moderate
                                                                                       with or without mild valvular         regurgitation or stenosis by
Valvular heart disease         Cardiac disorders          Tricuspid valve disease      regurgitation or stenosis             imaging



Ventricular arrhythmia                                                                 Asymptomatic, intervention not        Non-urgent medical intervention
Ventricular arrhythmia NOS     Cardiac disorders          Ventricular arrhythmia       indicated                             indicated



Ventricular arrhythmia
Ventricular fibrillation       Cardiac disorders          Ventricular fibrillation                       -                                    -



Ventricular arrhythmia                                                                                                       Non-urgent medical intervention
Ventricular tachycardia        Cardiac disorders          Ventricular tachycardia                        -                   indicated
Conduction
abnormality/atrioventricular
heart block Wolff-Parkinson-                              Wolff-Parkinson-White        Asymptomatic, intervention not        Non-urgent medical intervention
White Syndrome                 Cardiac disorders          Syndrome                     indicated                             indicated

                               Congenital, familial and
                               genetic disorders          Congenital anomaly                             -                   Mild anomalies




                                                                                                                             Moderate; minimal, local or
                                                          Congenital, familial and     Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                               Congenital, familial and   genetic disorders - other,   clinical or diagnostic observations   limiting age-appropriate
                               genetic disorders          specify                      only; intervention not indicated      instrumental ADL



5                                                                                                                                                                  1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC           Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2




                                                                                                                        Moderate; minimal, local or
                                                                                  Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Auditory/Ear - Other (Specify,   Ear and labyrinth   Ear and labyrinth - Other,   clinical or diagnostic observations   limiting age-appropriate
__)                              disorders           specify                      only; intervention not indicated      instrumental ADL
                                 Ear and labyrinth                                                                      Moderate pain; limiting
Pain Middle ear                  disorders           Ear pain                     Mild pain                             instrumental ADL


                                                                                                                       External otitis with moist
                                                                                                                       desquamation, edema, enhanced
                                                                                                                       cerumen or discharge; tympanic
Otitis, external ear (non-       Ear and labyrinth                                External otitis with erythema or dry membrane perforation;
infectious)                      disorders           External ear inflammation    desquamation                         tympanostomy
                                 Ear and labyrinth                                                                     Moderate pain; limiting
Pain External ear                disorders           External ear pain            Mild pain                            instrumental ADL




                                                                                                                       Adult only: Enrolled in Monitoring
                                                                                                                       Program(1, 2, 4, 6 and 8 kHz
                                                                                                                       )audiogram (on a 1, 2, 4, 6 and 8
                                                                                                                       kHz audiogram): Threshold shift
                                                                                  Adults Enrolled on a Monitoring      of > 25 dB averaged at 2
                                                                                  Program (on a 1, 2, 4, 6 and 8 kHz contiguous test frequencies in at
                                                                                  audiogram): Threshold shift of 15 - least one ear grade Adult only:
                                                                                   25 dB averaged at 2 contiguous      Not Enrolled in Monitoring
                                                                                  test frequencies in at least one     Program: Hearing loss not
                                                                                  ear; or subjective change in the     requiring hearing aid or
Hearing: patients without                                                         absence of a Grade 1 threshold       intervention (i.e., not interfering
baseline audiogram and not                                                        shift Pediatric (on a 1, 2, 4, 6 and with functional ADLs) Pediatric (on
enrolled in a monitoring         Ear and labyrinth                                8 kHz audiogram): > 20 dB at 8       a 1, 2, 4, 6 and 8 kHz audiogram):
program                          disorders           Hearing impaired             kHz                                  > 20 dB at 6 kHz and above

Otitis, middle ear (non-         Ear and labyrinth                                                                      Serous otitis, medical intervention
infectious)                      disorders           Middle ear inflammation      Serous otitis                         indicated
                                 Ear and labyrinth                                Mild symptoms; intervention not       Moderate symptoms; limiting
Tinnitus                         disorders           Tinnitus                     indicated                             instrumental ADL
                                 Ear and labyrinth                                                                      Symptomatic; limiting instrumental
Dizziness                        disorders           Vertigo                                        -                   ADL



6                                                                                                                                                             1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC              Proposed AE Term                Proposed Grade 1                    Proposed Grade 2
Neuropathy: cranial CN VIII      Ear and labyrinth                                                                        Symptomatic; limiting instrumental
Hearing and balance              disorders             Vestibular disorder                            -                   ADL
                                                                                    Asymptomatic; clinical or
                                                                                    diagnostic observations only;         Moderate symptoms; medical
Adrenal insufficiency            Endocrine disorders   Adrenal insufficiency        intervention not indicated            intervention indicated
Cushingoid appearance (e.g.,
moon face, buffalo hump,
centripetal obesity, cutaneous                                                      Mild symptoms; intervention not       Moderate symptoms; medical
striae)                          Endocrine disorders   Cushingoid                   indicated                             intervention indicated
                                                                                                                          No breast development by age 13
                                                                                                                          yrs for females; no Tanner Stage 2
                                                                                                                          development by age 14.5 yrs for
Puberty (delayed)                Endocrine disorders   Delayed puberty                                -                   males




                                                                                                                          Moderate; minimal, local or
                                                                                    Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                                                                                    clinical or diagnostic observations   limiting age-appropriate
Endocrine - Other (Specify, __) Endocrine disorders    Endocrine - Other, specify   only; intervention not indicated      instrumental ADL
Bone age (alteration in bone                                                                                              At least +2 SD (standard
age)                            Endocrine disorders    Growth accelerated                           -                     deviation) from normal
Parathyroid function, low                                                           Mild symptoms; intervention not       Moderate symptoms; medical
(hypoparathyroidism)            Endocrine disorders    Hyperparathyroidism          indicated                             intervention indicated

Thyroid function, high                                                              Asymptomatic; clinical or             Symptomatic; thyroid suppression
(hyperthyroidism,                                                                   diagnostic observations only;         therapy indicated; limiting
thyrotoxicosis)                  Endocrine disorders   Hyperthyroidism              intervention not indicated            instrumental ADL
                                                                                    Asymptomatic; clinical or
Parathyroid function, low                                                           diagnostic observations only;         Moderate symptoms; medical
(hypoparathyroidism)             Endocrine disorders   Hypoparathyroidism           intervention not indicated            intervention indicated
                                                                                    Asymptomatic; clinical or
Thyroid function, low                                                               diagnostic observations only;         Symptomatic; thyroid replacement
(hypothyroidism)                 Endocrine disorders   Hypothyroidism               intervention not indicated            indicated; limiting instrumental ADL

                                                                                    Physical signs of puberty, with no    Physical signs and biochemical
                                                                                    biochemical markers for females       markers of puberty for females <8
Puberty (precocious)             Endocrine disorders   Precocious puberty           <8 years and males <9 years           years and males <9 years
Thyroid function, high
(hyperthyroidism,
thyrotoxicosis)                  Endocrine disorders   Thyrotoxicosis                               -                                       -
                                                                                    Mild symptoms; intervention not       Moderate symptoms; medical
Masculinization of female        Endocrine disorders   Virilization                 indicated                             intervention indicated
                                                                                                                          Symptomatic; limiting instrumental
Vision-blurred vision            Eye disorders         Blurred vision               Intervention not indicated            ADL



7                                                                                                                                                                1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC        Proposed AE Term                 Proposed Grade 1                       Proposed Grade 2




                                                                               Asymptomatic; clinical or
                                                                               diagnostic observations only;         Symptomatic; moderate decrease
Cataract                          Eye disorders   Cataract                     intervention not indicated            in visual acuity (20/40 or better)

                                                                                                                     Symptomatic; topical intervention
                                                                               Asymptomatic or mild symptoms;        indicated (e.g., antibiotics); limiting
Ocular surface disease            Eye disorders   Conjunctivitis               intervention not indicated            instrumental AD



Keratitis (corneal                                                                                                   Symptomatic; medical intervention
inflammation/corneal                                                                                                 indicated (e.g., topical agents);
ulceration)                       Eye disorders   Corneal ulcer                                  -                   limiting instrumental ADL
                                                                               Asymptomatic; clinical or             Symptomatic; single systemic
                                                                               diagnostic observations only;         agent indicated; limiting
Dry eye syndrome                  Eye disorders   Dry eye                      relieved by lubricants                instrumental ADL
                                                                               Asymptomatic; clinical or
                                                                               diagnostic observations only;         Symptomatic; limiting instrumental
Proptosis/enophthalmos            Eye disorders   Exophthalmos                 intervention not indicated            ADL
Muscle weakness,
generalized or specific area                                                 Asymptomatic; clinical or
(not due to neuropathy)                                                      diagnostic observations only;           Symptomatic; limiting instrumental
Extraocular                       Eye disorders   Extraocular muscle paresis intervention not indicated              ADL




                                                                                                                     Moderate; minimal, local or
                                                                               Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Ocular/Visual - Other (Specify,                   Eye disorders - Other,       clinical or diagnostic observations   limiting age-appropriate
__)                             Eye disorders     specify                      only; intervention not indicated      instrumental ADL
                                                                                                                     Moderate pain; limiting
Pain Eye                          Eye disorders   Eye pain                     Mild pain                             instrumental ADL

                                                                               Asymptomatic; clinical or             Symptomatic; intervention
                                                                               diagnostic observations only;         indicated (e.g., topical agents or
Eyelid dysfunction                Eye disorders   Eyelid function disorder     intervention not indicated            epilation); limiting instrumental ADL

Vision-flashing lights/floaters   Eye disorders   Flashing lights              Intervention not indicated            Limiting instrumental ADL

Vision-flashing lights/floaters   Eye disorders   Floaters                     Intervention not indicated            Limiting instrumental ADL




8                                                                                                                                                              1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                   SOC        Proposed AE Term           Proposed Grade 1                      Proposed Grade 2




                                                                      Elevated IOP with single topical      Elevated IOP causing early visual
                                                                      agent for intervention; no visual     field deficits; multiple topical or
Glaucoma                       Eye disorders   Glaucoma               field deficit                         oral agents indicated

Keratitis (corneal                                                                                          Symptomatic; medical intervention
inflammation/corneal                                                                                        indicated (e.g., topical agents);
ulceration)                    Eye disorders   Keratitis                                 -                  limiting instrumental ADL
Night blindness (nyctalopia)   Eye disorders   Night blindness        Intervention not indicated            Limiting instrumental ADL
                                                                      Asymptomatic; clinical or
Neuropathy: cranial CN II                                             diagnostic observations only;         Limiting funciton of the affected
Vision                         Eye disorders   Optic nerve disorder   intervention not indicated            eye (20/40 or better)
                                                                                                            Visual field defect present; sparing
                                                                      Asymptomatic; no visual field         the central 20 degrees ;
Optic disc edema               Eye disorders   Papilledema            defects                               symptomatic decline in vision
Vision-photophobia             Eye disorders   Photophobia            Intervention not indicated            Limiting instrumental ADL




                                                                      Exudative; no central vision loss;    Exudative and visual acuity 20/40
Retinal detachment             Eye disorders   Retinal detachment     intervention not indicated            or better; intervention indicated
                                                                                                            Laser therapy or pneumopexy
Retinal detachment             Eye disorders   Retinal tear                             -                   indicated

                                                                      Asymptomatic; clinical or             Symptomatic with moderate
                                                                      diagnostic observations only;         decrease in visual acuity (20/40 or
Retinopathy                    Eye disorders   Retinopathy            intervention not indicated            better); limiting instrumental ADL

                                                                                                            Symptomatic; moderate decrease
                                                                      Asymptomatic; clinical or             in visual acuity (20/40 or better);
                                                                      diagnostic observations only;         medical intervention indicated;
Scleral necrosis/melt          Eye disorders   Scleral disorder       intervention not indicated            limiting instrumental ADL
                                                                      Asymptomatic; clinical or
                                                                      diagnostic observations only;         Anterior uveitis; medical
Uveitis                        Eye disorders   Uveitis                intervention not indicated            intervention indicated;

                                                                      Asymptomatic or mild symptoms;
                                                                      clinical or diagnostic observations   Symptomatic; limiting instrumental
Vitreous hemorrhage            Eye disorders   Vitreous hemorrhage    only; intervention not indicated      ADL

Watery eye (epiphora, tearing) Eye disorders   Watering eyes          Intervention not indicated            Intervention indicated




9                                                                                                                                                  1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC                  Proposed AE Term           Proposed Grade 1                 Proposed Grade 2
                                                                                  Asymptomatic; clinical or
                                                                                  diagnostic observations only;    Symptomatic; intervention not
Distension/bloating, abdominal Gastrointestinal disorders Abdominal distension    intervention not indicated       indicated
                                                                                                                   Moderate pain; limiting
Pain Abdomen NOS                Gastrointestinal disorders Abdominal pain         Mild pain                        instrumental ADL



                                                                                                                   Symptomatic; altered function
                                                                                  Asymptomatic; clinical or        (e.g., altered dietary habits,
                                                                                  diagnostic observations only;    diarrhea, or GI fluid loss); tube
Fistula, GI Anus                Gastrointestinal disorders Anal fistula           intervention not indicated       feedings;
                                                                                                                   Moderate symptoms; medical
                                                                                                                   intervention or minor cauterization
Hemorrhage, GI Anus             Gastrointestinal disorders Anal hemorrhage        Mild, self-limited               indicated

Mucositis/stomatitis                                                              Asymptomatic or mild symptoms;   Symptomatic; medical intervention
(functional/symptomatic) Anus Gastrointestinal disorders Anal mucositis           intervention not indicated       indicated; limiting instrumental ADL




Necrosis, GI Anus               Gastrointestinal disorders Anal necrosis                               -                            -
                                                                                                                   Moderate pain; limiting
Pain Anus                       Gastrointestinal disorders Anal pain              Mild pain                        instrumental ADL




                                                                                  Asymptomatic; clinical or
Stricture/stenosis (including                                                     diagnostic observations only;
anastomotic), GI Anus           Gastrointestinal disorders Anal stenosis          intervention not indicated       Symptomatic; altered GI function;



                                                                                  Asymptomatic; clinical or        Symptomatic; altered GI function
                                                                                  diagnostic observations only;    (e.g. altered dietary habits,
Ulcer, GI Anus                  Gastrointestinal disorders Anal ulcer             intervention not indicated       vomiting, diarrhea)
                                                                                  Asymptomatic; clinical or
                                                                                  diagnostic observations only;    Symptomatic; medical intervention
Ascites (non-malignant)         Gastrointestinal disorders Ascites                intervention not indicated       indicated

                                                                                  No change in bowel function or   Symptomatic, decreased oral
Distension/bloating, abdominal Gastrointestinal disorders Bloating                oral intake                      intake; change in bowel function
                                                                                                                   Moderate symptoms; medical
Hemorrhage, GI                                                                                                     intervention or minor cauterization
Cecum/appendix                  Gastrointestinal disorders Cecal hemorrhage       Mild, self-limited               indicated




10                                                                                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

          CTCAE v3.0 Term                 SOC                   Proposed AE Term           Proposed Grade 1                     Proposed Grade 2
                                                                                   Asymptomatic; clinical or
                                                                                   diagnostic observations only;        Moderate symptoms; limiting
Cheilitis                       Gastrointestinal disorders Cheilitis               intervention not indicated           instrumental ADL

                                                                                   Asymptomatic; clinical or
                                                                                   diagnostic observations only;        Abdominal pain; mucus or blood in
Colitis                         Gastrointestinal disorders Colitis                 intervention not indicated           stool




                                                                                   Asymptomatic; clinical or            Symptomatic; altered GI function
Fistula, GI                                                                        diagnostic observations only;        (e.g., altered dietary habits,
Colon/cecum/appendix            Gastrointestinal disorders Colonic fistula         intervention not indicated           diarrhea, or GI fluid loss);
                                                                                                                        Moderate symptoms; medical
                                                                                                                        intervention or minor cauterization
Hemorrhage, GI Colon            Gastrointestinal disorders Colonic hemorrhage      Mild, self-limited                   indicated

                                                                                   Asymptomatic; clinical or            Symptomatic; altered GI function
                                                                                   diagnostic observations only;        (e.g., altered dietary habits,
Obstruction, GI Colon           Gastrointestinal disorders Colonic obstruction     intervention not indicated           vomiting, diarrhea, or GI fluid loss);

                                                                                                                        Symptomatic; medical intervention
Perforation, GI Colon           Gastrointestinal disorders Colonic perforation                          -               indicated

                                                                                   Asymptomatic; clinical or
Stricture/stenosis (including                                                      diagnostic observations only;
anastomotic), GI Colon          Gastrointestinal disorders Colonic stenosis        intervention not indicated           Symptomatic; altered GI function;



                                                                                   Asymptomatic; clinical or            Symptomatic; altered GI function
                                                                                   diagnostic observations only;        (e.g. altered dietary habits,
Ulcer, GI Colon                 Gastrointestinal disorders Colonic ulcer           intervention not indicated           vomiting, diarrhea)
                                                                                   Occasional or intermittent
                                                                                   symptoms; occasional use of stool
                                                                                   softeners, laxatives, dietary     Persistent symptoms with regular
Constipation                    Gastrointestinal disorders Constipation            modification, or enema            use of laxatives or enemas



                                                                                                                        Increase of 4 - 6 stools per day
                                                                                   Increase of <4 stools per day over   over baseline; moderate increase
                                                                                   baseline; mild increase in ostomy    in ostomy output compared to
Diarrhea                        Gastrointestinal disorders Diarrhea                output compared to baseline          baseline




11                                                                                                                                                               1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC                   Proposed AE Term           Proposed Grade 1                     Proposed Grade 2
                                                                                                                         Moderate symptoms; oral intake
                                                                                                                         alteration (e.g., copious water,
                                                                                    Symptomatic (dry or thick saliva)    other lubricants, diet limited to
                                                                                    without significant dietary          purees and/or soft, moist foods);
Dry mouth/salivary gland                                                            alteration; unstimulated saliva flow unstimulated saliva 0.1 to 0.2
(xerostomia)                     Gastrointestinal disorders Dry mouth               >0.2 ml/min                          ml/min



                                                                                                                         Symptomatic; altered GI function
                                                                                    Asymptomatic; clinical or            (e.g., altered dietary habits,
                                                                                    diagnostic observations only;        diarrhea, or GI fluid loss); tube
Fistula, GI Duodenum             Gastrointestinal disorders Duodenal fistula        intervention not indicated           feedings;
                                                                                                                         Moderate symptoms; medical
                                                                                                                         intervention or minor cauterization
Hemorrhage, GI Duodenum          Gastrointestinal disorders Duodenal hemorrhage     Mild, self-limited                   indicated

                                                                                    Asymptomatic; clinical or            Symptomatic; altered GI function
                                                                                    diagnostic observations only;        (e.g., altered dietary habits,
Obstruction, GI Duodenum         Gastrointestinal disorders Duodenal obstruction    intervention not indicated           vomiting, diarrhea, or GI fluid loss);

                                                                                                                         Symptomatic; medical intervention
Perforation, GI Duodenum         Gastrointestinal disorders Duodenal perforation                         -               indicated

                                                                                    Asymptomatic; clinical or
Stricture/stenosis (including                                                       diagnostic observations only;
anastomotic), GI Duodenum        Gastrointestinal disorders Duodenal stenosis       intervention not indicated           Symptomatic; altered GI function;



                                                                                    Asymptomatic; clinical or            Moderate symptoms; medical
                                                                                    diagnostic observations only;        intervention indicated; limiting
Ulcer, GI Duodenum               Gastrointestinal disorders Duodenal ulcer          intervention not indicated           instrumental ADL
                                                                                    Mild symptoms; intervention not
Heartburn/dyspepsia              Gastrointestinal disorders Dyspepsia               indicated                            Moderate symptoms




                                                                                                                         Symptomatic and altered
Dysphagia (difficulty                                                               Symptomatic, able to eat regular     eating/swallowing (e.g., altered
swallowing)                      Gastrointestinal disorders Dysphagia               diet                                 dietary habits, oral supplements);
                                                                                    Asymptomatic; clinical or
Enteritis (inflammation of the                                                      diagnostic observations only;        Abdominal pain; mucus or blood in
small bowel)                     Gastrointestinal disorders Enteritis               intervention not indicated           stool
Mucositis/stomatitis                                                                Asymptomatic; clinical or
(functional/symptomatic)                                                            diagnostic observations only;        Abdominal pain; mucus or blood in
Small bowel                      Gastrointestinal disorders Enterocolitis           intervention not indicated           stool



12                                                                                                                                                                1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC                  Proposed AE Term             Proposed Grade 1                 Proposed Grade 2
                                                                                    Asymptomatic; clinical or
                                                                                    diagnostic observations only;    Symptomatic; noninvasive
Fistula, GU Bladder             Gastrointestinal disorders Enterovesical fistula    intervention not indicated       intervention indicated



                                                                                    Asymptomatic; clinical or        Symptomatic; altered GI function
                                                                                    diagnostic observations only;    (e.g., altered dietary habits,
Fistula, GI Esophagus           Gastrointestinal disorders Esophageal fistula       intervention not indicated       diarrhea, or GI fluid loss);
                                                                                                                     Moderate symptoms; medical
                                                                                                                     intervention or minor cauterization
Hemorrhage, GI Esophagus        Gastrointestinal disorders Esophageal hemorrhage    Mild, self-limited               indicated

Mucositis/stomatitis
(functional/symptomatic)                                                            Asymptomatic or mild symptoms;   Symptomatic; altered dietary
Esophagus                       Gastrointestinal disorders Esophageal mucositis     intervention not indicated       habits;




Necrosis, GI Esophagus          Gastrointestinal disorders Esophageal necrosis                           -                             -

                                                                                    Asymptomatic; clinical or        Symptomatic; altered GI function
                                                                                    diagnostic observations only;    (e.g., altered dietary habits,
Obstruction, GI Esophagus       Gastrointestinal disorders Esophageal obstruction   intervention not indicated       vomiting, diarrhea, or GI fluid loss);
                                                                                                                     Moderate pain; limiting
Pain Esophagus                  Gastrointestinal disorders Esophageal pain          Mild pain                        instrumental ADL

                                                                                                                     Symptomatic; medical intervention
Perforation, GI Esophagus       Gastrointestinal disorders Esophageal perforation                        -           indicated

                                                                                    Asymptomatic; clinical or
Stricture/stenosis (including                                                       diagnostic observations only;
anastomotic), GI Esophagus      Gastrointestinal disorders Esophageal stenosis      intervention not indicated       Symptomatic; altered GI function;



                                                                                    Asymptomatic; clinical or        Symptomatic; altered GI function
                                                                                    diagnostic observations only;    (e.g. altered dietary habits,
Ulcer, GI Esophagus             Gastrointestinal disorders Esophageal ulcer         intervention not indicated       vomiting, diarrhea)

Hemorrhage, GI Varices                                     Esophageal varices
(esophageal)                    Gastrointestinal disorders hemorrhage                                    -           Self-limited process




13                                                                                                                                                            1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC                   Proposed AE Term           Proposed Grade 1                  Proposed Grade 2




                                                                                   Asymptomatic; clinical or         Symptomatic; altered
                                                                                   diagnostic observations only;     eating/swallowing (e.g., altered
Esophagitis                     Gastrointestinal disorders Esophagitis             intervention not indicated        dietary habits, oral supplements)

Incontinence, anal              Gastrointestinal disorders Fecal incontinence      Occasional use of pads required   Daily use of pads required
                                                                                   Mild symptoms; intervention not   Moderate; persistent psychosocial
Flatulence                      Gastrointestinal disorders Flatulence              indicated                         sequelae




                                                                                   Asymptomatic; clinical or         Symptomatic; altered GI function
                                                                                   diagnostic observations only;     (e.g., altered dietary habits,
Fistula, GI Stomach             Gastrointestinal disorders Gastric fistula         intervention not indicated        diarrhea, or GI fluid loss);
                                                                                                                     Moderate symptoms; medical
                                                                                                                     intervention or minor cauterization
Hemorrhage, GI Stomach          Gastrointestinal disorders Gastric hemorrhage      MIld, self-limited                indicated

Mucositis/stomatitis
(functional/symptomatic)                                                           Asymptomatic or mild symptoms;    Symptomatic; medical intervention
Stomach                         Gastrointestinal disorders Gastric mucositis       intervention not indicated        indicated; limiting instrumental ADL




Necrosis, GI Stomach            Gastrointestinal disorders Gastric necrosis                             -                             -

                                                                                                                     Symptomatic; medical intervention
Perforation, GI Stomach         Gastrointestinal disorders Gastric perforation                          -            indicated

                                                                                   Asymptomatic; clinical or
Stricture/stenosis (including                                                      diagnostic observations only;
anastomotic), GI Stomach        Gastrointestinal disorders Gastric stenosis        intervention not indicated        Symptomatic; altered GI function;



                                                                                   Asymptomatic; clinical or         Symptomatic; altered GI function
                                                                                   diagnostic observations only;     (e.g. altered dietary habits,
Ulcer, GI Stomach               Gastrointestinal disorders Gastric ulcer           intervention not indicated        vomiting, diarrhea)




14                                                                                                                                                          1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                        SOC                    Proposed AE Term              Proposed Grade 1                      Proposed Grade 2

                                                                                                                                Symptomatic; altered
                                                                                          Asymptomatic; clinical or             eating/gastric function (e.g.,
Gastritis (including bile reflux                                                          diagnostic observations only;         altered dietary habits, oral
gastritis)                         Gastrointestinal disorders Gastritis                   intervention not indicated            supplements)




                                                                                                                                Moderate; minimal, local or
                                                                                          Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Gastrointestinal - Other                                      Gastrointestinal - Other,   clinical or diagnostic observations   limiting age-appropriate
(Specify, __)                      Gastrointestinal disorders specify                     only; intervention not indicated      instrumental ADL



                                                                                          Asymptomatic; clinical or             Symptomatic; altered GI function
                                                                                          diagnostic observations only;         (e.g., altered dietary habits,
Fistula, GI Abdomen NOS            Gastrointestinal disorders Gastrointestinal fistula    intervention not indicated            diarrhea, or GI fluid loss);
                                                                                                                                Moderate pain; limiting
Pain Intestine                     Gastrointestinal disorders Gastrointestinal pain       Mild pain                             instrumental ADL
                                                                                                                                Moderate pain; limiting
Pain Oral-gums                     Gastrointestinal disorders Gingival pain               Mild pain                             instrumental ADL
                                                                                                                                Moderate symptoms; medical
Hemorrhage, GI Varices                                                                                                          intervention or minor cauterization
(rectal)                           Gastrointestinal disorders Hemorrhoidal hemorrhage     Mild, self-limited                    indicated
                                                                                          Asymptomatic; clinical or
                                                                                          diagnostic observations only;         Symptomatic; banding or medical
Hemorrhoids                        Gastrointestinal disorders Hemorrhoids                 intervention not indicated            intervention indicated




                                                                                          Asymptomatic; clinical or             Symptomatic; altered GI function
                                                                                          diagnostic observations only;         (e.g., altered dietary habits,
Fistula, GI Ileum                  Gastrointestinal disorders Ileal fistula               intervention not indicated            diarrhea, or GI fluid loss);
                                                                                                                                Moderate symptoms; medical
                                                                                                                                intervention or minor cauterization
Hemorrhage, GI Ileum               Gastrointestinal disorders Ileal hemorrhage            Mild, self-limited                    indicated

                                                                                          Asymptomatic; clinical or             Symptomatic; altered GI function
                                                                                          diagnostic observations only;         (e.g., altered dietary habits,
Obstruction, GI Ileum              Gastrointestinal disorders Ileal obstruction           intervention not indicated            vomiting, diarrhea, or GI fluid loss);

                                                                                                                                Symptomatic; medical intervention
Perforation, GI Ileum              Gastrointestinal disorders Ileal perforation                                -                indicated




15                                                                                                                                                                       1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC                   Proposed AE Term           Proposed Grade 1                Proposed Grade 2

                                                                                   Asymptomatic; clinical or
Stricture/stenosis (including                                                      diagnostic observations only;
anastomotic), GI Ileum          Gastrointestinal disorders Ileal stenosis          intervention not indicated      Symptomatic; altered GI function;



                                                                                   Asymptomatic; clinical or       Symptomatic; altered GI function
                                                                                   diagnostic observations only;   (e.g. altered dietary habits,
Ulcer, GI Ileum                 Gastrointestinal disorders Ileal ulcer             intervention not indicated      vomiting, diarrhea)
Ileus, GI (functional                                                                                              Symptomatic; altered GI function
obstruction of bowel, i.e.,                                                                                        (e.g., altered dietary habits); bowel
neuroconstipation)              Gastrointestinal disorders Ileus                                        -          rest indicated




Necrosis, GI
Colon/cecum/appendix            Gastrointestinal disorders Intestinal necrosis                          -                            -
                                                                                                                   Moderate symptoms; medical
Hemorrhage, GI Abdomen                                     Intra-abdominal                                         intervention or minor cauterization
NOS                             Gastrointestinal disorders hemorrhage              Mild, self-limited              indicated




                                                                                   Asymptomatic; clinical or       Symptomatic; altered GI function
                                                                                   diagnostic observations only;   (e.g., altered dietary habits,
Fistula, GI Jejunum             Gastrointestinal disorders Jejunal fistula         intervention not indicated      diarrhea, or GI fluid loss);
                                                                                                                   Moderate symptoms; medical
                                                                                                                   intervention or minor cauterization
Hemorrhage, GI Jejunum          Gastrointestinal disorders Jejunal hemorrhage      Mild, self-limited              indicated

                                                                                   Asymptomatic; clinical or       Symptomatic; altered GI function
                                                                                   diagnostic observations only;   (e.g., altered dietary habits,
Obstruction, GI Jejunum         Gastrointestinal disorders Jejunal obstruction     intervention not indicated      vomiting, diarrhea, or GI fluid loss);

                                                                                                                   Symptomatic; medical intervention
Perforation, GI Jejunum         Gastrointestinal disorders Jejunal perforation                          -          indicated

                                                                                   Asymptomatic; clinical or
Stricture/stenosis (including                                                      diagnostic observations only;
anastomotic), GI Jejunum        Gastrointestinal disorders Jejunal stenosis        intervention not indicated      Symptomatic; altered GI function;



                                                                                   Asymptomatic; clinical or       Symptomatic; altered GI function
                                                                                   diagnostic observations only;   (e.g. altered dietary habits,
Ulcer, GI Jejunum               Gastrointestinal disorders Jejunal ulcer           intervention not indicated      vomiting, diarrhea)



16                                                                                                                                                          1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC                   Proposed AE Term                Proposed Grade 1                        Proposed Grade 2
Mucositis/stomatitis
(functional/symptomatic)                                                                Asymptomatic or mild symptoms;          Symptomatic; medical intervention
Large bowel                     Gastrointestinal disorders Large intestinal mucositis   intervention not indicated              indicated; limiting instrumental ADL
                                                                                                                                Moderate pain; limiting
Pain Lip                        Gastrointestinal disorders Lip pain                     Mild pain                               instrumental ADL
                                                                                                                                Moderate symptoms; medical
Hemorrhage, GI Lower GI                                    Lower gastrointestinal                                               intervention or minor cauterization
NOS                             Gastrointestinal disorders hemorrhage                   Mild, self-limited                      indicated

                                                                                                                                Altered diet; oral intervention
                                                                                                                                indicated (e.g., enzymes,
Malabsorption                   Gastrointestinal disorders Malabsorption                                     -                  medications, dietary supplements)




Necrosis, GI Oral               Gastrointestinal disorders Mouth necrosis                                    -                                    -

                                                                                                                                Oral intake decreased without
                                                                                        Loss of appetite without alteration     significant weight loss, dehydration
Nausea                          Gastrointestinal disorders Nausea                       in eating habits                        or malnutrition;

                                                                                        Asymptomatic; clinical or               Symptomatic; altered GI function
                                                                                        diagnostic observations only;           (e.g., altered dietary habits,
Obstruction, GI Stomach         Gastrointestinal disorders Obstruction gastric          intervention not indicated              vomiting, diarrhea, or GI fluid loss);




                                                                                        Asymptomatic; clinical or               Symptomatic; altered GI function
                                                                                        diagnostic observations only;           (e.g., altered dietary habits,
Fistula, GI Oral cavity         Gastrointestinal disorders Oral cavity fistula          intervention not indicated              diarrhea, or GI fluid loss);
                                                                                        Mild discomfort; not interfering with   Moderate pain; interfering with oral
Laryngeal nerve dysfunction     Gastrointestinal disorders Oral dysesthesia             oral intake                             intake
                                                                                                                                Moderate symptoms; medical
                                                                                                                                intervention or minor cauterization
Hemorrhage, GI Oral cavity      Gastrointestinal disorders Oral hemorrhage              Mild, self-limited                      indicated
                                                                                                                                Moderate pain; limiting
Pain Oral cavity                Gastrointestinal disorders Oral pain                    Mild pain                               instrumental ADL

Stricture/stenosis (including                                                           Asymptomatic; clinical or
anastomotic), GI                                                                        diagnostic observations only;
Pancreas/pancreatic duct        Gastrointestinal disorders Pancreatic duct stenosis     intervention not indicated              Symptomatic; altered GI function;




17                                                                                                                                                                       1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC                   Proposed AE Term           Proposed Grade 1                      Proposed Grade 2




                                                                                    Asymptomatic; clinical or             Symptomatic; altered GI function
                                                                                    diagnostic observations only;         (e.g., altered dietary habits,
Fistula, GI Pancreas             Gastrointestinal disorders Pancreatic fistula      intervention not indicated            diarrhea, or GI fluid loss);
                                                                                                                          Moderate symptoms; medical
                                                                                                                          intervention or minor cauterization
Hemorrhage, GI Pancreas          Gastrointestinal disorders Pancreatic hemorrhage   Mild, self-limited                    indicated




Necrosis, GI Pancreas            Gastrointestinal disorders Pancreatic necrosis                          -                                   -



                                                                                                                          Enzyme elevation or radiologic
Pancreatitis                     Gastrointestinal disorders Pancreatitis                                 -                findings only

                                                                                    Gingival recession or gingivitis;     Moderate gingival recession or
                                                                                    limited bleeding on probing; mild     gingivitis; multiple sites of bleeding
Dental: periodontal disease      Gastrointestinal disorders Periodontal disease     local bone loss                       on probing; moderate bone loss




Necrosis, GI Peritoneal cavity   Gastrointestinal disorders Peritoneal necrosis                          -                                 -
                                                                                                                          Moderate pain; limiting
Pain Peritoneum                  Gastrointestinal disorders Peritoneal pain         Mild pain                             instrumental ADL

                                                                                                                          Symptoms (e.g., rectal discomfort,
                                                                                                                          passing blood or mucus), medical
                                                                                    Rectal discomfort, intervention not   intervention indicated; limiting
Proctitis                        Gastrointestinal disorders Proctitis               indicated                             instrumental ADL




                                                                                    Asymptomatic; clinical or             Symptomatic; altered GI function
                                                                                    diagnostic observations only;         (e.g., altered dietary habits,
Fistula, GI Rectum               Gastrointestinal disorders Rectal fistula          intervention not indicated            diarrhea, or GI fluid loss);
                                                                                                                          Moderate symptoms; medical
                                                                                                                          intervention or minor cauterization
Hemorrhage, GI Rectum            Gastrointestinal disorders Rectal hemorrhage       Mild, self-limited                    indicated



18                                                                                                                                                                 1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC                  Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2
Mucositis/stomatitis
(functional/symptomatic)                                                                Asymptomatic or mild symptoms;        Symptomatic; medical intervention
Rectum                          Gastrointestinal disorders Rectal mucositis             intervention not indicated            indicated; limiting instrumental ADL




Necrosis, GI Rectum             Gastrointestinal disorders Rectal necrosis                                -                                     -

                                                                                        Asymptomatic; clinical or             Symptomatic; altered GI function
                                                                                        diagnostic observations only;         (e.g., altered dietary habits,
Obstruction, GI Rectum          Gastrointestinal disorders Rectal obstruction           intervention not indicated            vomiting, diarrhea, or GI fluid loss);
                                                                                                                              Moderate pain; limiting
Pain Rectum                     Gastrointestinal disorders Rectal pain                  Mild pain                             instrumental ADL

                                                                                                                              Symptomatic; medical intervention
Perforation, GI Rectum          Gastrointestinal disorders Rectal perforation                             -                   indicated

                                                                                        Asymptomatic; clinical or
Stricture/stenosis (including                                                           diagnostic observations only;
anastomotic), GI Rectum         Gastrointestinal disorders Rectal stenosis              intervention not indicated            Symptomatic; altered GI function;



                                                                                        Asymptomatic; clinical or             Symptomatic; altered GI function
                                                                                        diagnostic observations only;         (e.g. altered dietary habits,
Ulcer, GI Rectum                Gastrointestinal disorders Rectal ulcer                 intervention not indicated            vomiting, diarrhea)

Hemorrhage, GU                                                                                                                Moderate; self-limited; medical
Retroperitoneum                 Gastrointestinal disorders Retroperitoneal hemorrhage                     -                   intervention indicated
                                                                                                                              Thick, ropy, sticky saliva; markedly
                                                                                                                              altered taste; alteration in diet
                                                                                                                              indicated; secretion-induced
                                                                                        Slightly thickened saliva; slightly   symptoms; limiting instrumental
Salivary gland changes/saliva   Gastrointestinal disorders Salivary duct inflammation   altered taste (e.g., metallic)        ADL



                                                                                                                              Symptomatic; altered GI function
                                                                                        Asymptomatic; clinical or             (e.g., altered dietary habits,
                                                                                        diagnostic observations only;         diarrhea, or GI fluid loss); tube
Fistula, GI Salivary gland      Gastrointestinal disorders Salivary gland fistula       intervention not indicated            feedings;

Mucositis/stomatitis
(functional/symptomatic)                                                                Asymptomatic or mild symptoms;        Symptomatic; medical intervention
Small bowel                     Gastrointestinal disorders Small intestinal mucositis   intervention not indicated            indicated; limiting instrumental ADL




19                                                                                                                                                                     1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC                  Proposed AE Term                   Proposed Grade 1                     Proposed Grade 2




Necrosis, GI Small bowel NOS Gastrointestinal disorders Small intestinal necrosis                            -                                    -

                                                                                         Asymptomatic; clinical or              Symptomatic; altered GI function
Obstruction, GI Small bowel                                                              diagnostic observations only;          (e.g., altered dietary habits,
NOS                              Gastrointestinal disorders Small intestinal obstruction intervention not indicated             vomiting, diarrhea, or GI fluid loss);

Perforation, GI Small bowel                                                                                                     Symptomatic; medical intervention
NOS                              Gastrointestinal disorders Small intestinal perforation                     -                  indicated



Stricture/stenosis (including                                                              Asymptomatic; clinical or
anastomotic), GI Small bowel                                                               diagnostic observations only;
NOS                              Gastrointestinal disorders Small intestinal stenosis      intervention not indicated           Symptomatic; altered GI function;



                                                                                           Asymptomatic; clinical or            Symptomatic; altered GI function
                                                                                           diagnostic observations only;        (e.g. altered dietary habits,
Ulcer, GI Small bowel NOS        Gastrointestinal disorders Small intestine ulcer          intervention not indicated           vomiting, diarrhea)
                                                                                                                                Moderate pain; limiting
Pain Stomach                     Gastrointestinal disorders Stomach pain                   Mild pain                            instrumental ADL



Mucositis/stomatitis
(functional/symptomatic) Oral                                                              Asymptomatic or mild symptoms;       Moderate pain; not interfering oral
cavity                           Gastrointestinal disorders Stomatitis                     intervention not indicated           intake; modified diet indicated

                                                            Tooth development              Asymptomatic; hypoplasia of tooth Impairment correctable with oral
Dental: teeth development        Gastrointestinal disorders disorder                       or enamel                         surgery

Dental: teeth                    Gastrointestinal disorders Tooth discoloration            Surface stains                                         -

                                                                                                                                Less than full mouth extractions;
                                                                                           Dental caries; restorable, without   tooth fracture or crown amputation
Dental: teeth                    Gastrointestinal disorders Tooth disorder                 extractions                          or repair indicated
                                                                                                                                Moderate pain; limiting
Pain Dental/teeth/peridontal     Gastrointestinal disorders Toothache                      Mild pain                            instrumental ADL




Typhlitis (cecal inflammation)   Gastrointestinal disorders Typhlitis                                        -                                    -




20                                                                                                                                                                       1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                    SOC                 Proposed AE Term              Proposed Grade 1                       Proposed Grade 2
                                                                                                                          Moderate symptoms; medical
Hemorrhage, GI Upper GI                                   Upper gastrointestinal                                          intervention or minor cauterization
NOS                            Gastrointestinal disorders hemorrhage               Mild, self-limited                     indicated



                                                                                   1 - 2 episodes (separated by 5         3 - 5 episodes (separated by 5
Vomiting                       Gastrointestinal disorders Vomiting                 minutes) in 24 hrs                     minutes) in 24 hrs;
                               General disorders and                               Mild lack or loss of bodily strength   Moderate lack or loss of bodily
Fatigue (asthenia, lethargy,   administration site                                 or energy; mild generalized            strength or energy; limiting
malaise)                       conditions               Asthenia                   weakness                               instrumental ADL
                               General disorders and
                               administration site                                 Mild sensation of cold; shivering;     Moderate tremor of the entire
Rigors/chills                  conditions               Chills                     chattering of teeth                    body; narcotics indicated
                               General disorders and
Death not associated with      administration site
CTCAE term Sudden death        conditions               Death                                           -                                   -
                               General disorders and
Death not associated with      administration site
CTCAE term Sudden death        conditions               Death neonatal                                  -                                   -



                                                                                                                          >10 - 30% inter-limb discrepancy
                                                                                                                          in volume or circumference at
                                                                                   5 - 10% inter-limb discrepancy in      point of greatest visible difference;
                                                                                   volume or circumference at point       readily apparent obscuration of
                                                                                   of greatest visible difference;        anatomic architecture; obliteration
                               General disorders and                               swelling or obscuration of             of skin folds; readily apparent
                               administration site                                 anatomic architecture on close         deviation from normal anatomic
Edema: limb                    conditions               Edema limbs                inspection                             contour; limiting instrumental ADL
                                                                                                                          Readily apparent obscuration of
                                                                                                                          anatomic architecture; obliteration
                               General disorders and                               Swelling or obscuration of             of skin folds; readily apparent
                               administration site                                 anatomic architecture on close         deviation from normal anatomic
Edema: trunk/genital           conditions               Edema trunk                inspection                             contour
                               General disorders and
                               administration site                                                                        Moderate localized facial edema;
Edema: head and neck           conditions               Face edema                 Localized facial edema                 limiting instrumental ADLs
                               General disorders and
                               administration site                                                                        Moderate pain; limiting
Pain Face                      conditions               Facial pain                Mild pain                              instrumental ADL
                               General disorders and
Fatigue (asthenia, lethargy,   administration site                                                                        Fatigue not relieved by rest;
malaise)                       conditions               Fatigue                    Fatigue relieved by rest               limiting instrumental ADL




21                                                                                                                                                                1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC                 Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2
Fever (in the absence of
neutropenia, where            General disorders and
neutropenia is defined as ANC administration site                                      38.0 - 39.0 degrees C (100.4 -        >39.0 - 40.0 degrees C (102.3 -
<1.0 x 10e9/L)                conditions                 Fever                         102.2 degrees F)                      104.0 degrees F)
                                 General disorders and
                                 administration site                                                                         Moderate symptoms; limiting
Flu-like syndrome                conditions              Flu like symptoms             Mild flu-like symptoms present.       instrumental ADL

                                                                                                                             Moderate change in gait (e.g.,
                                 General disorders and                                                                       wide-based, limping or hobbling);
                                 administration site                                   Mild change in gait (e.g., wide-      assistive device indicated; limiting
Extremity-lower (gait/walking)   conditions              Gait disturbance              based, limping or hobbling)           instrumental ADL




                                                                                                                             Moderate; minimal, local or
                                 General disorders and   General, and                  Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Constitutional Symptoms -        administration site     administration site           clinical or diagnostic observations   limiting age-appropriate
Other (Specify, __)              conditions              conditions - Other, specify   only; intervention not indicated      instrumental ADL




                                 General disorders and
                                 administration site                                                                         35 - >32 degrees C 95 - >89.6
Hypothermia                      conditions              Hypothermia                                     -                   degrees F




                                                                                                                             Therapy or infusion interruption
                                                                                                                             indicated but responds promptly to
                                                                                                                             symptomatic treatment (e.g.,
Cytokine release                 General disorders and                                 Mild transient reaction; infusion     antihistamines, NSAIDS,
syndrome/acute infusion          administration site                                   interruption not indicated;           narcotics, IV fluids); prophylactic
reaction                         conditions              Infusion related reaction     intervention not indicated            medications indicated for <=24 hrs
                               General disorders and                                                                         Erythema with associated
Injection site                 administration site                                                                           symptoms (e.g., edema, pain,
reaction/extravasation changes conditions                Infusion site extravasation                     -                   induration, phlebitis)
                               General disorders and                                   Tenderness with or without
Injection site                 administration site                                     associated symptoms (e.g.,            Pain; lipodystrophy; edema;
reaction/extravasation changes conditions                Injection site reaction       warmth, erythema, itching)            phlebitis




22                                                                                                                                                                  1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC                    Proposed AE Term           Proposed Grade 1                       Proposed Grade 2



                                   General disorders and                             Quick excitability resulting in        Quick excitability resulting in
Irritability (children <3 years of administration site                               annoyance, impatience, or anger        annoyance, impatience, or anger
age)                               conditions              Irritability              that is easily consolable              that is not easily consolable
                                 General disorders and                                                                      Moderate localized edema
                                 administration site                                 Localized to dependent areas, no       requiring intervention; limiting
Edema: head and neck             conditions                Localized edema           disability or functional impairment.   instrumental ADL
                                 General disorders and
Fatigue (asthenia, lethargy,     administration site                                                                        Uneasiness or lack of well being;
malaise)                         conditions                Malaise                   Uneasiness or lack of well being       limiting instrumental ADL
Death not associated with        General disorders and
CTCAE term Multi-organ           administration site
failure                          conditions                Multi-organ failure                         -                                      -
                                 General disorders and
                                 administration site                                 Asymptomatic localized neck            Moderate neck edema; slight
Edema: head and neck             conditions                Neck edema                edema                                  obliteration of anatomic landmarks
                                 General disorders and
                                 administration site                                                                        Moderate pain; limiting
Pain Chest/thorax NOS            conditions                Non-cardiac chest pain    Mild pain                              instrumental ADL
                                 General disorders and
                                 administration site                                                                        Moderate pain; limiting
Pain Pain NOS                    conditions                Pain                      Mild pain                              instrumental ADL

                                                                                                                            Edema that retains for a time the
                                 General disorders and                               Edema that retains for a time the      indentation produced by pressure,
                                 administration site                                 indentation produced by pressure       intervention indicated (e.g.,
Edema: limb                      conditions                Pitting edema             noticed on observation                 medication, compression hose)

                                 General disorders and                                                                   Moderate occlusion causing
Thrombosis/embolism              administration site                                 Minimal occlusion; intervention not dysfunction of catheter;
(vascular access-related)        conditions                Thrombus in catheter      indicated                           intervention indicated

                                                                                                                            Symptomatic; altered GI function
                                                                                     Asymptomatic; clinical or              (e.g., altered dietary habits,
Stricture/stenosis (including                                                        diagnostic observations only;          vomiting, bleeding, diarrhea); IV
anastomotic), GI Biliary tree    Hepatobiliary disorders   Bile duct stenosis        intervention not indicated             fluids indicated <24 hrs




                                                                                                                            Symptomatic and intervention not
Fistula, GI Biliary tree         Hepatobiliary disorders   Biliary fistula                             -                    indicated




23                                                                                                                                                               1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC                 Proposed AE Term              Proposed Grade 1                      Proposed Grade 2

                                                                                                                           Symptomatic; medical intervention
Cholecystitis                    Hepatobiliary disorders   Cholecystitis                                  -                indicated




                                                                                     Asymptomatic clinical or
                                                                                     diagnostic observations only;         Symptomatic and intervention not
Fistula, GI Gallbladder          Hepatobiliary disorders   Gallbladder fistula       intervention not indicated            indicated




Necrosis, GI Gallbladder         Hepatobiliary disorders   Gallbladder necrosis                           -                                   -



                                                                                                                           Symptomatic; altered GI function
                                                                                     Asymptomatic; clinical or             (e.g. altered dietary habits,
                                                                                     diagnostic observations only;         vomiting, diarrhea); IV fluids
Obstruction, GI Gallbladder      Hepatobiliary disorders   Gallbladder obstruction   intervention not indicated            indicated <12 hours
                                                                                                                           Moderate pain; limiting
Pain Gallbladder                 Hepatobiliary disorders   Gallbladder pain          Mild pain                             instrumental ADL



Perforation, GI Gallbladder      Hepatobiliary disorders   Gallbladder perforation                        -                                   -

                                                                                                                           Symptomatic; medical intervention
Hemorrhage, GI Liver             Hepatobiliary disorders   Hepatic hemorrhage        Mild, self-limited                    indicated




Necrosis, GI Hepatic             Hepatobiliary disorders   Hepatic necrosis                               -                                 -
                                                                                                                           Moderate pain; limiting
Pain Liver                       Hepatobiliary disorders   Hepatic pain              Mild pain                             instrumental ADL




                                                                                                                           Moderate; minimal, local or
                                                                                     Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Hepatobiliary/Pancreas -                                   Hepatobiliary - Other,    clinical or diagnostic observations   limiting age-appropriate
Other (Specify, __)              Hepatobiliary disorders   specify                   only; intervention not indicated      instrumental ADL

Bilirubin (hyperbilirubinemia)   Hepatobiliary disorders   Hyperbilirubinemia        >ULN - 1.5 x ULN                      >1.5 - 3.0 x ULN



Perforation, GI Biliary tree     Hepatobiliary disorders   Perforation bile duct                          -                                   -



24                                                                                                                                                               1/6/2011
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      CTCAE v3.0 Term                  SOC                 Proposed AE Term                Proposed Grade 1                      Proposed Grade 2



Portal vein flow             Hepatobiliary disorders   Portal hypertension                           -                   Decreased portal vein flow



Portal vein flow             Hepatobiliary disorders   Portal vein thrombosis                        -                   Intervention not indicated




                                                                                                                         Intervention or infusion interruption
                                                                                                                         indicated; responds promptly to
                                                                                   Transient flushing or rash, drug      symptomatic treatment (e.g.,
Allergic                                                                           fever <38 degrees C (<100.4           antihistamines, NSAIDS,
reaction/hypersensitivity                                                          degrees F); intervention not          narcotics); prophylactic
(including drug fever)       Immune system disorders Allergic reaction             indicated                             medications indicated for <=24 hrs




Allergic
reaction/hypersensitivity
(including drug fever)       Immune system disorders Anaphylaxis                                     -                                     -

                                                                                   Asymptomatic; serologic or other
                                                                                   evidence of autoimmune reaction,      Evidence of autoimmune reaction
                                                                                   with normal organ function;           involving a non-essential organ or
Autoimmune reaction          Immune system disorders Autoimmune disorder           intervention not indicated            function (e.g., hypothyroidism)




                                                                                                                         Therapy or infusion interruption
                                                                                                                         indicated but responds promptly to
                                                                                                                         symptomatic treatment (e.g.,
Cytokine release                                                               Mild reaction; infusion interruption      antihistamines, NSAIDS,
syndrome/acute infusion                                                        not indicated; intervention not           narcotics, IV fluids); prophylactic
reaction                     Immune system disorders Cytokine release syndrome indicated                                 medications indicated for <=24 hrs




                                                                                                                         Moderate; minimal, local or
                                                                                   Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Allergy/Immunology - Other                           Immune system - Other,        clinical or diagnostic observations   limiting age-appropriate
(Specify, __)                Immune system disorders specify                       only; intervention not indicated      instrumental ADL




25                                                                                                                                                               1/6/2011
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      CTCAE v3.0 Term                  SOC               Proposed AE Term             Proposed Grade 1                 Proposed Grade 2
                                                                              Asymptomatic; clinical or
                                                                              diagnostic observations only;   Moderate arthralgia, fever, rash,
Serum sickness               Immune system disorders Serum sickness           intervention not indicated      urticaria, antihistamines indicated



Infection with unknown ANC   Infections and
Abdomen NOS                  infestations           Abdominal infection                         -                                -



Infection with unknown ANC   Infections and                                   Localized; local intervention   Oral intervention indicated (e.g.,
Anal/perianal                infestations           Anal infection            indicated                       antibiotic, antifungal, or antiviral)
                                                                                                              Localized, local intervention
                                                                                                              indicated; oral intervention
Infection with unknown ANC   Infections and                                                                   indicated (e.g., antibiotic,
Rectum                       infestations           Anorectal infection                         -             antifungal, antiviral)



Infection with unknown ANC   Infections and
Appendix                     infestations           Appendicitis                                -                                -

                             Infections and                                                                   Symptomatic; medical intervention
Perforation, GI Appendix     infestations           Appendicitis perforated                     -             indicated



Infection with unknown ANC   Infections and
Artery                       infestations           Arteritis infective                         -                                -



Infection with unknown ANC   Infections and
Biliary tree                 infestations           Biliary tract infection                     -                                -



Infection with unknown ANC   Infections and                                                                   Oral intervention indicated (e.g.,
Bladder (urinary)            infestations           Bladder infection                           -             antibiotic, antifungal, or antiviral)



Infection with unknown ANC   Infections and
Bone (osteomyelitis)         infestations           Bone infection                              -                                -
                                                                                                              Local infection with moderate
                                                                                                              symptoms; oral intervention
Infection with unknown ANC   Infections and                                                                   indicated (e.g., antibiotic,
Bone (osteomyelitis)         infestations           Breast infection                            -             antifungal, antiviral)




26                                                                                                                                                    1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC        Proposed AE Term          Proposed Grade 1            Proposed Grade 2

                                                                                                   Moderate symptoms; oral
Infection with unknown ANC      Infections and                                                     intervention indicated (e.g.,
Bronchus                        infestations      Bronchial infection                  -           antibiotic, antifungal, antiviral)
                                                                                                   Localized, local intervention
                                                                                                   indicated; oral intervention
Infection with unknown ANC      Infections and                                                     indicated (e.g., antibiotic,
Catheter-related                infestations      Catheter related infection           -           antifungal, antiviral)



Infection with unknown ANC      Infections and
Cecum                           infestations      Cecal infection                      -                              -

                                                                                                   Localized, local intervention
Infection with unknown ANC      Infections and                                                     indicated (e.g., topical antibiotic,
Conjunctiva                     infestations      Conjunctivitis infective             -           antifungal, or antiviral)

                                                                                                   Localized, local intervention
Infection with unknown ANC      Infections and                                                     indicated (e.g., topical antibiotic,
Cornea                          infestations      Corneal infection                    -           antifungal, or antiviral)



Infection with unknown ANC      Infections and
Nerve-cranial                   infestations      Cranial nerve infection              -                              -

Infection with unknown ANC
Foreign body (e.g., graft,      Infections and
implant, prosthesis, stent)     infestations      Device related infection             -                              -

                                                                                                   Moderate symptoms; medical
Infection with unknown ANC      Infections and                                                     intervention indicated (e.g., oral
Duodenum                        infestations      Duodenal infection                   -           antibiotics)




Infection with unknown ANC       Infections and
Brain (encephalitis, infectious) infestations     Encephalitis infection               -                              -

Infection with unknown ANC
Brain + Spinal cord             Infections and
(encephalomyelitis)             infestations      Encephalomyelitis infection          -                              -




27                                                                                                                                        1/6/2011
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      CTCAE v3.0 Term                       SOC         Proposed AE Term                   Proposed Grade 1                       Proposed Grade 2



Infection with unknown ANC        Infections and
Heart (endocarditis)              infestations     Endocarditis infective                            -                                      -
                                  Infections and
Ocular surface disease            infestations     Endophthalmitis                                   -                   Local intervention indicated



Infection with unknown ANC        Infections and                                                                         Local intervention indicated (e.g,
Esophagus                         infestations     Esophageal infection                              -                   oral antibiotic, antifungal, antiviral)
                                                                                                                         Localized, local intervention
                                                                                                                         indicated; oral intervention
Infection with unknown ANC        Infections and                                                                         indicated (e.g., antibiotic,
Eye NOS                           infestations     Eye infection                                     -                   antifungal, antiviral)



Infection with unknown ANC        Infections and
Gallbladder (cholecystitis)       infestations     Gallbladder infection                             -                                      -

                                                                                                                         Moderate symptoms; oral
Infection with unknown ANC        Infections and                                                                         intervention indicated (e.g.,
Urinary tract NOS                 infestations     Genitourinary tract infection                     -                   antibiotic, antifungal, antiviral)

                                                                                                                         Moderate symptoms; oral
Infection with unknown ANC        Infections and                                                                         intervention indicated (e.g.,
Oral cavity-gums (gingivitis)     infestations     Gum infection                                     -                   antibiotic, antifungal, antiviral)



Infection with unknown ANC        Infections and
Liver                             infestations     Hepatic infection                                 -                                      -



                                  Infections and
Viral hepatitis                   infestations     Hepatitis viral                                   -                                      -

Infection with unknown ANC                                                                                               Localized, local intervention
Foreign body (e.g., graft,        Infections and                                                                         indicated (e.g., topical antibiotic,
implant, prosthesis, stent)       infestations     Implant infection                                 -                   antifungal, or antiviral)




                                                                                                                         Moderate; minimal, local or
                                                                                   Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                                  Infections and                                   clinical or diagnostic observations   limiting age-appropriate
Infection - Other (Specify, __)   infestations     Infections - Other, specify     only; intervention not indicated      instrumental ADL



28                                                                                                                                                                 1/6/2011
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      CTCAE v3.0 Term                   SOC         Proposed AE Term   Proposed Grade 1            Proposed Grade 2




                                                                                          Passage of >3 unformed stools
                                                                                          per 24 hours or duration of illness
Infection with unknown ANC    Infections and                                              >48 hours; moderate abdominal
Colon                         infestations     Infectious colitis             -           pain




Infection with unknown ANC    Infections and
Meninges (meningitis)         infestations     Infectious meningitis          -                              -
                                                                                          Localized, local intervention
                                                                                          indicated; oral intervention
Infection with unknown ANC    Infections and                                              indicated (e.g., antibiotic,
Cervix                        infestations     Infective cervicitis           -           antifungal, antiviral)
                                                                                          Localized, local intervention
                                                                                          indicated; oral intervention
Infection with unknown ANC    Infections and                                              indicated (e.g., antibiotic,
Muscle (infection myositis)   infestations     Infective myositis             -           antifungal, antiviral)
                                                                                          Localized, local intervention
                                                                                          indicated; oral intervention
                                                                                          indicated (e.g., antibiotic,
                                                                                          antifungal, antiviral); needle
                              Infections and                                              aspiration indicated (single or
Joint Infection               infestations     Joint infection                -           multiple)



Infection with unknown ANC    Infections and
Kidney                        infestations     Kidney infection               -                              -

                                                                                          Moderate symptoms; oral
Infection with unknown ANC    Infections and                                              intervention indicated (e.g.,
Larynx                        infestations     Laryngitis                     -           antibiotic, antifungal, antiviral)
                                                                                          Localized, local intervention
                                                                                          indicated; oral intervention
Infection with unknown ANC    Infections and                                              indicated (e.g., antibiotic,
Lip/perioral                  infestations     Lip infection                  -           antifungal, antiviral)

                                                                                          Moderate symptoms; oral
Infection with unknown ANC    Infections and                                              intervention indicated (e.g.,
Lung (pneumonia)              infestations     Lung infection                 -           antibiotic, antifungal, antiviral)




29                                                                                                                              1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                     SOC        Proposed AE Term              Proposed Grade 1              Proposed Grade 2
                                                                                                         Localized, local intervention
                                                                                                         indicated; oral intervention
Infection with unknown ANC      Infections and                                                           indicated (e.g., antibiotic,
Lymphatic                       infestations     Lymph gland infection                     -             antifungal, antiviral)



Infection with unknown ANC      Infections and
Mediastinum NOS                 infestations     Mediastinal infection                     -                               -
                                                                                                         Localized, local intervention
                                                                                                         indicated; oral intervention
Infection with unknown ANC      Infections and                                                           indicated (e.g., antibiotic,
Mucosa                          infestations     Mucosal infection                         -             antifungal, antiviral)
                                                                                                         Localized, local intervention
                                                                                                         indicated; oral intervention
Infection with unknown ANC      Infections and                                                           indicated (e.g., antibiotic,
Ungual (nails)                  infestations     Nail infection                            -             antifungal, antiviral)
                                                                                                         Localized, local intervention
                                                                                                         indicated; oral intervention
Infection with unknown ANC      Infections and                                                           indicated (e.g., antibiotic,
External ear (otitis externa)   infestations     Otitis externa                            -             antifungal, antiviral)
                                                                                                         Localized, local intervention
                                                                                                         indicated; oral intervention
Infection with unknown ANC      Infections and                                                           indicated (e.g., antibiotic,
Middle ear (otitis media)       infestations     Otitis media                              -             antifungal, antiviral)
                                                                                                         Localized, local intervention
                                                                                                         indicated; oral intervention
Infection with unknown ANC      Infections and                                                           indicated (e.g., antibiotic,
Cervix                          infestations     Ovarian infection                         -             antifungal, antiviral)



Infection with unknown ANC      Infections and
Pancreas                        infestations     Pancreas infection                        -                               -

                                                                                                         10-30% of BSA; associated with
                                                                                                         symptoms of pruritus or pain;
                                Infections and                                                           associated with psychosocial
Rash/desquamation               infestations     Papulopustular rash         Asymptomatic; <10% of BSA   impact; limiting instrumental ADL
                                                                                                         Localized, local intervention
                                                                                                         indicated; oral intervention
Infection with unknown ANC      Infections and                                                           indicated (e.g., antibiotic,
Paranasal                       infestations     Paranasal sinus infection                 -             antifungal, antiviral)




30                                                                                                                                           1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

     CTCAE v3.0 Term                   SOC         Proposed AE Term               Proposed Grade 1                 Proposed Grade 2


                                                                                                          Localized intervention indicated;
                                                                                                          oral intervention indicated (e.g.,
                                                                                                          antibiotic, antifungal, antiviral; nail
                                                                                                          fold edema or erythema with pain;
                                                                                                          associated with discharge or nail
                             Infections and                                Nail fold edema or erythema;   plate separation; limiting
Nail changes                 infestations     Paronychia                   disruption of the cuticle      instrumental ADL

                                                                                                          Moderate symptoms; oral
Infection with unknown ANC   Infections and                                                               intervention indicated (e.g.,
Pelvis NOS                   infestations     Pelvic infection                             -              antibiotic, antifungal, antiviral)
                                                                                                          Localized, local intervention
                                                                                                          indicated; oral intervention
Infection with unknown ANC   Infections and                                                               indicated (e.g., antibiotic,
Penis                        infestations     Penile infection                             -              antifungal, antiviral)
                                                                                                          Localized, local intervention
                                                                                                          indicated; oral intervention
Infection with unknown ANC   Infections and                                                               indicated (e.g., antibiotic,
Eye NOS                      infestations     Periorbital infection                        -              antifungal, antiviral)
                                                                                                          Localized, local intervention
                                                                                                          indicated; oral intervention
Infection with unknown ANC   Infections and                                                               indicated (e.g., antibiotic,
Nerve-peripheral             infestations     Peripheral nerve infection                   -              antifungal, antiviral)



Infection with unknown ANC   Infections and
Peritoneal cavity            infestations     Peritoneal infection                         -                                 -

                                                                                                          Localized, local intervention
Infection with unknown ANC   Infections and                                                               indicated (e.g., topical antibiotic,
Pharynx                      infestations     Pharyngitis                                  -              antifungal, or antiviral)
                                                                                                          Localized, local intervention
                                                                                                          indicated; oral intervention
Infection with unknown ANC   Infections and                                                               indicated (e.g., antibiotic,
Vein                         infestations     Phlebitis infective                          -              antifungal, antiviral)
                                                                                                          Localized, local intervention
                                                                                                          indicated; oral intervention
Infection with unknown ANC   Infections and                                                               indicated (e.g., antibiotic,
Pleura (empyema)             infestations     Pleural infection                            -              antifungal, antiviral)

                                                                                                          Moderate symptoms; oral
Infection with unknown ANC   Infections and                                                               intervention indicated (e.g.,
Prostate                     infestations     Prostate infection                           -              antibiotic, antifungal, antiviral)




31                                                                                                                                                  1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

     CTCAE v3.0 Term                   SOC         Proposed AE Term      Proposed Grade 1            Proposed Grade 2
                                                                                            Localized, local intervention
                                                                                            indicated; oral intervention
                             Infections and                                                 indicated (e.g., antibiotic,
Rash: acne/acneiform         infestations     Rash pustular                     -           antifungal, antiviral)
                                                                                            Localized, local intervention
                                                                                            indicated; oral intervention
Infection with unknown ANC   Infections and                                                 indicated (e.g., antibiotic,
Nose                         infestations     Rhinitis infective                -           antifungal, antiviral)

                                                                                            Moderate symptoms; oral
Infection with unknown ANC   Infections and                                                 intervention indicated (e.g.,
Salivary gland               infestations     Salivary gland infection          -           antibiotic, antifungal, antiviral)
                                                                                            Localized, local intervention
                                                                                            indicated; oral intervention
Infection with unknown ANC   Infections and                                                 indicated (e.g., antibiotic,
Scrotum                      infestations     Scrotal infection                 -           antifungal, antiviral)




32                                                                                                                               1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

     CTCAE v3.0 Term                   SOC        Proposed AE Term        Proposed Grade 1            Proposed Grade 2




                             Infections and
Sepsis                       infestations     Sepsis                             -                              -
                                                                                             Localized, local intervention
                                                                                             indicated; oral intervention
Infection with unknown ANC   Infections and                                                  indicated (e.g., antibiotic,
Sinus                        infestations     Sinusitis                          -           antifungal, antiviral)
                                                                                             Localized, local intervention
                                                                                             indicated; oral intervention
Infection with unknown ANC   Infections and                                                  indicated (e.g., antibiotic,
Skin (cellulitis)            infestations     Skin infection                     -           antifungal, antiviral)

                                                                                             Moderate symptoms; oral
Infection with unknown ANC   Infections and                                                  intervention indicated (e.g.,
Small bowel NOS              infestations     Small intestine infection          -           antibiotic, antifungal, antiviral)




33                                                                                                                                1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

     CTCAE v3.0 Term                    SOC        Proposed AE Term          Proposed Grade 1            Proposed Grade 2
                                                                                                Localized, local intervention
                                                                                                indicated; oral intervention
Infection with unknown ANC    Infections and                                                    indicated (e.g., antibiotic,
Soft tissue NOS               infestations     Soft tissue infection                -           antifungal, antiviral)



Infection with unknown ANC    Infections and
Spleen                        infestations     Splenic infection                    -                              -
                                                                                                Localized, local intervention
                                                                                                indicated; oral intervention
Infection with unknown ANC    Infections and                                                    indicated (e.g., antibiotic,
Peristomal                    infestations     Stoma site infection                 -           antifungal, antiviral)
                                                                                                Localized, local intervention
                                                                                                indicated; oral intervention
Infection with unknown ANC    Infections and                                                    indicated (e.g., antibiotic,
Dental-tooth                  infestations     Tooth infection                      -           antifungal, antiviral)

                                                                                                Moderate symptoms; oral
Infection with unknown ANC    Infections and                                                    intervention indicated (e.g.,
Trachea                       infestations     Tracheitis                           -           antibiotic, antifungal, antiviral)

                                                                                                Moderate symptoms; oral
Infection with unknown ANC    Infections and                                                    intervention indicated (e.g.,
Upper airway NOS              infestations     Upper respiratory infection          -           antibiotic, antifungal, antiviral)
                                                                                                Localized, local intervention
                                                                                                indicated; oral intervention
Infection with unknown ANC    Infections and                                                    indicated (e.g., antibiotic,
Urethra                       infestations     Urethral infection                   -           antifungal, antiviral)
                                                                                                Localized, local intervention
                                                                                                indicated; oral intervention
Infection with unknown ANC    Infections and                                                    indicated (e.g., antibiotic,
Bladder (urinary)             infestations     Urinary tract infection              -           antifungal, antiviral)

                                                                                                Moderate symptoms; oral
Infection with unknown ANC    Infections and                                                    intervention indicated (e.g.,
Uterus                        infestations     Uterine infection                    -           antibiotic, antifungal, antiviral)
                                                                                                Localized, local intervention
                                                                                                indicated; oral intervention
Infection with unknown ANC    Infections and                                                    indicated (e.g., antibiotic,
Vagina                        infestations     Vaginal infection                    -           antifungal, antiviral)
                                                                                                Localized, local intervention
Infection with unknown ANC                                                                      indicated; oral intervention
Foreign body (e.g., graft,    Infections and                                                    indicated (e.g., antibiotic,
implant, prosthesis, stent)   infestations     Vascular implant infection           -           antifungal, antiviral)




34                                                                                                                                   1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

       CTCAE v3.0 Term                    SOC                 Proposed AE Term              Proposed Grade 1                   Proposed Grade 2
                                                                                                                       Localized, local intervention
                                                                                                                       indicated; oral intervention
Infection with unknown ANC      Infections and                                                                         indicated (e.g., antibiotic,
Vulva                           infestations             Vulval infection                            -                 antifungal, antiviral)
                                                                                                                       Localized, local intervention
                                                                                                                       indicated; oral intervention
Infection with unknown ANC      Infections and                                                                         indicated (e.g., antibiotic,
Wound                           infestations             Wound infection                             -                 antifungal, antiviral)

                                                                                                                       Symptomatic (e.g., claudication);
                                Injury, poisoning and                               Asymptomatic diagnostic finding;   limiting instrumental ADL; repair or
Vessel injury-artery Aorta      procedural complications Aortic injury              intervention not indicated         revision not indicated



                               Injury, poisoning and                                Asymptomatic diagnostic finding;   Symptomatic (e.g., claudication);
Vessel injury-artery Other NOS procedural complications Arterial injury             intervention not indicated         repair or revision not indicated
                                                                                    Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                               diagnostic observations only;      Symptomatic; medical intervention
GI Biliary tree                 procedural complications Biliary anastomotic leak   intervention not indicated         indicated
                                                                                    Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                               diagnostic observations only;      Symptomatic; medical intervention
GU Bladder                      procedural complications Bladder anastomotic leak   intervention not indicated         indicated

Bruising (in absence of Grade   Injury, poisoning and
3 or 4 thrombocytopenia)        procedural complications Bruising                   Localized or in a dependent area   Generalized




                                                                                                                       Moderate to brisk erythema;
                                Injury, poisoning and                               Faint erythema or dry              patchy moist desquamation;
Burn                            procedural complications Chemical Burn              desquamation                       moderate edema; itching; burning



                                                                                                                       Moderate to brisk erythema;
                                                                                                                       patchy moist desquamation,
Rash: dermatitis associated     Injury, poisoning and                               Faint erythema or dry              mostly confined to skin folds and
with radiation Radiation        procedural complications Dermatitis radiation       desquamation                       creases; moderate edema



                                                                                    Asymptomatic; clinical or          Symptomatic; local wound care or
Local complication -            Injury, poisoning and                               diagnostic observations only;      medical intervention indicated;
device/prosthesis-related       procedural complications Device complication        intervention not indicated         limiting instrumental ADL;




35                                                                                                                                                            1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC                   Proposed AE Term                Proposed Grade 1                      Proposed Grade 2

                                                                                         Asymptomatic; clinical or
Leak (including anastomotic),    Injury, poisoning and    Esophageal anastomotic         diagnostic observations only;         Symptomatic; medical intervention
GI Esophagus                     procedural complications leak                           intervention not indicated            indicated

                                 Injury, poisoning and                                   Minor with no resultant injuries;     Symptomatic; noninvasive
Fracture                         procedural complications Fall                           intervention not indicated            intervention indicated
                                                                                     Asymptomatic; clinical or
Leak (including anastomotic),    Injury, poisoning and    Fallopian tube anastomotic diagnostic observations only;             Symptomatic; medical intervention
GU Fallopian tube                procedural complications leak                       intervention not indicated                indicated



                                                                                         Asymptomatic clinical or
                               Injury, poisoning and                                     diagnostic observations only;         Symptomatic and intervention not
Perforation, GU Fallopian tube procedural complications Fallopian tube perforation       intervention not indicated            indicated

                                                                                         Asymptomatic; clinical or
                                 Injury, poisoning and                                   diagnostic observations only;         Symptomatic but non-displaced;
Fracture                         procedural complications Fracture                       intervention not indicated            immobilization indicated
                                                                                         Asymptomatic; clinical or
Leak (including anastomotic),    Injury, poisoning and                                   diagnostic observations only;         Symptomatic; medical intervention
GI Stomach                       procedural complications Gastric anastomotic leak       intervention not indicated            indicated
                                                                                         Asymptomatic; clinical or
Leak (including anastomotic),    Injury, poisoning and    Gastrointestinal               diagnostic observations only;         Symptomatic; medical intervention
GI Leak NOS                      procedural complications anastomotic leak               intervention not indicated            indicated

                                 Injury, poisoning and    Gastrointestinal stoma                                               Superficial necrosis; intervention
Necrosis, GI Stoma               procedural complications necrosis                                         -                   not indicated




                                                                                                                               Moderate; minimal, local or
                                                                                         Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Intra-operative Injury - Other   Injury, poisoning and                                   clinical or diagnostic observations   limiting age-appropriate
(Specify, __)                    procedural complications Injury - Other, specify        only; intervention not indicated      instrumental ADL



                                 Injury, poisoning and
Vessel injury-artery Carotid     procedural complications Injury to carotid artery                         -                                     -

                                 Injury, poisoning and
Vessel injury-vein IVC           procedural complications Injury to inferior vena cava                     -                                     -

                                 Injury, poisoning and
Vessel injury-vein Jugular       procedural complications Injury to jugular vein                           -                                     -



36                                                                                                                                                                   1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

      CTCAE v3.0 Term                      SOC                  Proposed AE Term                  Proposed Grade 1                Proposed Grade 2



                                 Injury, poisoning and                                 Asymptomatic diagnostic finding;   Symptomatic; repair or revision
Vessel injury-vein SVC           procedural complications Injury to superior vena cava intervention not indicated         not indicated
                                                                                          Asymptomatic; clinical or
Leak (including anastomotic),    Injury, poisoning and                                    diagnostic observations only;   Symptomatic; medical intervention
GI Stoma                         procedural complications Intestinal stoma leak           intervention not indicated      indicated




                                 Injury, poisoning and                                                                    Self-limited; intervention not
Obstruction, GI Stoma            procedural complications Intestinal stoma obstruction                      -             indicated

                                 Injury, poisoning and    Intestinal stoma site           Asymptomatic; spotting;         Bleeding; cauterization or stitching
Hemorrhage, GI Stoma             procedural complications bleeding                        intervention not indicated      indicated



Intra-operative injury Artery    Injury, poisoning and                                   Primary repair of injured        Partial resection of injured
NOS                              procedural complications Intraoperative arterial injury organ/structure indicated        organ/structure indicated



                                 Injury, poisoning and                                 Primary repair of injured          Partial resection of injured
Intra-operative injury Breast    procedural complications Intraoperative breast injury organ/structure indicated          organ/structure indicated

                                 Injury, poisoning and
Intra-operative injury Heart     procedural complications Intraoperative cardiac injury                     -                               -



                                 Injury, poisoning and                                    Primary repair of injured       Partial resection of injured
Intra-operative injury Inner ear procedural complications Intraoperative ear injury       organ/structure indicated       organ/structure indicated



Intra-operative injury Adrenal   Injury, poisoning and    Intraoperative endocrine        Primary repair of injured       Partial resection of injured
gland                            procedural complications injury                          organ/structure indicated       organ/structure indicated



Intra-operative injury           Injury, poisoning and    Intraoperative                  Primary repair of injured       Partial resection of injured
Abdomen NOS                      procedural complications gastrointestinal injury         organ/structure indicated       organ/structure indicated



Intra-operative injury Face      Injury, poisoning and    Intraoperative head and         Primary repair of injured       Partial resection of injured
NOS                              procedural complications neck injury                     organ/structure indicated       organ/structure indicated




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      CTCAE v3.0 Term                      SOC                 Proposed AE Term                   Proposed Grade 1            Proposed Grade 2

Hemorrhage/bleeding
associated with surgery, intra- Injury, poisoning and
operative or postoperative      procedural complications Intraoperative hemorrhage                         -                            -



Intra-operative injury Biliary   Injury, poisoning and    Intraoperative hepatobiliary Primary repair of injured      Partial resection of injured
tree NOS                         procedural complications injury                       organ/structure indicated      organ/structure indicated



                                 Injury, poisoning and    Intraoperative                  Primary repair of injured   Partial resection of injured
Intra-operative injury Bone      procedural complications musculoskeletal injury          organ/structure indicated   organ/structure indicated



                                 Injury, poisoning and    Intraoperative neurological     Primary repair of injured   Partial resection of injured
Intra-operative injury Brain     procedural complications injury                          organ/structure indicated   organ/structure indicated



                               Injury, poisoning and                                 Primary repair of injured        Partial resection of injured
Intra-operative injury Eye NOS procedural complications Intraoperative ocular injury organ/structure indicated        organ/structure indicated



                                 Injury, poisoning and                                    Primary repair of injured   Partial resection of injured
Intra-operative injury Kidney    procedural complications Intraoperative renal injury     organ/structure indicated   organ/structure indicated



Intra-operative injury Pelvis    Injury, poisoning and    Intraoperative reproductive Primary repair of injured       Partial resection of injured
NOS                              procedural complications tract injury                organ/structure indicated       organ/structure indicated



Intra-operative injury Upper     Injury, poisoning and    Intraoperative respiratory      Primary repair of injured   Partial resection of injured
airway NOS                       procedural complications injury                          organ/structure indicated   organ/structure indicated



                                 Injury, poisoning and                                    Primary repair of injured   Partial resection of injured
Intra-operative injury Skin      procedural complications Intraoperative skin injury      organ/structure indicated   organ/structure indicated

                                 Injury, poisoning and                                                                Primary repair of injured
Intra-operative injury Spleen    procedural complications Intraoperative splenic injury                    -          organ/structure indicated



Intra-operative injury Urinary   Injury, poisoning and                                  Primary repair of injured     Partial resection of injured
tract NOS                        procedural complications Intraoperative urinary injury organ/structure indicated     organ/structure indicated




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      CTCAE v3.0 Term                    SOC                  Proposed AE Term                 Proposed Grade 1                Proposed Grade 2



                                Injury, poisoning and                                 Primary repair of injured        Partial resection of injured
Intra-operative injury Vein NOS procedural complications Intraoperative venous injury organ/structure indicated        organ/structure indicated
                                                                                       Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                                  diagnostic observations only;   Symptomatic; medical intervention
GU Kidney                       procedural complications Kidney anastomotic leak       intervention not indicated      indicated
                                                                                       Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and    Large intestinal              diagnostic observations only;   Symptomatic; medical intervention
GI Large bowel                  procedural complications anastomotic leak              intervention not indicated      indicated
                                                                                     Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                                diagnostic observations only;     Symptomatic; medical intervention
GI Pancreas                     procedural complications Pancreatic anastomotic leak intervention not indicated        indicated
                                                                                       Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and    Pharyngeal anastomotic        diagnostic observations only;   Symptomatic; medical intervention
GI Pharynx                      procedural complications leak                          intervention not indicated      indicated




Hemorrhage/bleeding                                                                                                    Postoperative interventional
associated with surgery, intra- Injury, poisoning and                                                                  radiologic, endoscopic, or
operative or postoperative      procedural complications Postoperative hemorrhage                       -              operative intervention indicated

Prolonged intubation after
pulmonary resection (>24 hrs    Injury, poisoning and    Postoperative thoracic                                        Extubated within 24 - 72 hrs
after surgery)                  procedural complications procedure complication                         -              postoperatively
                                                                                                                       Recurrent after manual reduction;
                                                                                                                       local irritation; stool leakage;
                                Injury, poisoning and                                                                  limiting instrumental ADL; difficulty
Prolapse of stoma, GI           procedural complications Prolapse of intestinal stoma Asymptomatic; reducible          to fit appliance
                                                                                       Asymptomatic; clinical or
                                Injury, poisoning and                                  diagnostic observations only;   Local care or maintenance; minor
Prolapse of stoma, GU           procedural complications Prolapse of urostomy          intervention not indicated      revision indicated



                                                                                                                       Moderate to brisk erythema;
                                                                                                                       patchy moist desquamation,
Rash: dermatitis associated     Injury, poisoning and    Radiation recall reaction     Faint erythema or dry           mostly confined to skin folds and
with radiation Chemoradiation   procedural complications (dermatologic)                desquamation                    creases; moderate edema
                                                                                       Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                                  diagnostic observations only;   Symptomatic; medical intervention
GI Rectum                       procedural complications Rectal anastomotic leak       intervention not indicated      indicated




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       CTCAE v3.0 Term                   SOC                  Proposed AE Term                  Proposed Grade 1                   Proposed Grade 2
                                                                                        Asymptomatic; clinical or
                                Injury, poisoning and                                   diagnostic observations only;      Symptomatic; simple aspiration
Seroma                          procedural complications Seroma                         intervention not indicated         indicated
                                                                                        Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and    Small intestinal               diagnostic observations only;      Symptomatic; medical intervention
GI Small bowel                  procedural complications anastomotic leak               intervention not indicated         indicated
                                                                                        Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and    Spermatic cord                 diagnostic observations only;      Symptomatic; medical intervention
GU Spermatic cord               procedural complications anastomotic leak               intervention not indicated         indicated



                                                                                                                           Symptomatic (e.g., altered dietary
                                                                                                                           habits, vomiting, diarrhea); IV
Stricture/stenosis (including   Injury, poisoning and    Stenosis of gastrointestinal                                      fluids indicated <12 hrs; manual
anastomotic), GI Stoma          procedural complications stoma                                           -                 dilatation at bedside
                                                                                        Asymptomatic; clinical or
                                Injury, poisoning and                                   diagnostic observations only;      Symptomatic; medical intervention
Ulcer, GI Stoma                 procedural complications Stomal ulcer                   intervention not indicated         indicated



                                                                                                                        Moderate to brisk erythema;
                                                                                                                        patchy moist desquamation;
                                Injury, poisoning and                                   Faint erythema or dry           itching; burning; 10 - 30% BSA
Burn                            procedural complications Thermal burn                   desquamation; <10% BSA affected affected



Hemorrhage,
pulmonary/upper respiratory     Injury, poisoning and                                   Mild symptoms; intervention not    Symptomatic; medical intervention
Trachea                         procedural complications Tracheal hemorrhage            indicated                          indicated

                                                                                                                           Symptomatic (e.g., noisy airway
                                                                                        Partial asymptomatic obstruction   breathing); no respiratory distress;
Obstruction/stenosis of airway Injury, poisoning and                                    on examinaton (e.g., visual,       medical intervention indicated
Trachea                        procedural complications Tracheal obstruction            radiologic or endoscopic)          (e.g., steroids)



Hemorrhage,
pulmonary/upper respiratory     Injury, poisoning and                               Mild symptoms; intervention not        Symptomatic; medical intervention
Stoma                           procedural complications Tracheostomy site bleeding indicated                              indicated
                                                                                        Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                                   diagnostic observations only;      Symptomatic; medical intervention
GU Ureter                       procedural complications Ureteric anastomotic leak      intervention not indicated         indicated
                                                                                        Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                                   diagnostic observations only;      Symptomatic; medical intervention
GU Urethra                      procedural complications Urethral anastomotic leak      intervention not indicated         indicated



40                                                                                                                                                                1/6/2011
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      CTCAE v3.0 Term                    SOC                 Proposed AE Term               Proposed Grade 1                    Proposed Grade 2
                                                                                    Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                               diagnostic observations only;       Symptomatic; medical intervention
GU Stoma                        procedural complications Urostomy leak              intervention not indicated          indicated

                                                                                    Asymptomatic; clinical or           Symptomatic; dilation or
                                Injury, poisoning and                               diagnostic observations only;       endoscopic repair or stent
Obstruction, GU Stoma           procedural complications Urostomy obstruction       intervention not indicated          placement indicated



                                Injury, poisoning and                               Minimal or microscopic bleeding;    Medical intervention or urinary
Hemorrhage, GU Stoma            procedural complications Urostomy site bleeding     intervention not indicated          tract irrigation indicated
                                                                                                                        Symptomatic but no
                                                                                                                        hydronephrosis, no sepsis or no
                                                                                                                        renal dysfunction; dilation or
Stricture/stenosis (including   Injury, poisoning and                                                                   endoscopic repair or stent
anastomotic), GU Stoma          procedural complications Urostomy stenosis                           -                  placement indicated
                                                                                    Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                               diagnostic observations only;       Symptomatic; medical intervention
GU Uterus                       procedural complications Uterine anastomotic leak   intervention not indicated          indicated
                                                                                    Asymptomatic clinical or
                                Injury, poisoning and                               diagnostic observations only;       Symptomatic and intervention not
Perforation, GU Uterus          procedural complications Uterine perforation        intervention not indicated          indicated
                                                                                    Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and                               diagnostic observations only;       Symptomatic; medical intervention
GU Vagina                       procedural complications Vaginal anastomotic leak   intervention not indicated          indicated
                                                                                    Asymptomatic; clinical or
Leak (including anastomotic),   Injury, poisoning and    Vas deferens anastomotic   diagnostic observations only;       Symptomatic; medical intervention
GU Vas deferens                 procedural complications leak                       intervention not indicated          indicated



                                                                                                                        Device dislodgement, blockage,
                                                                                                                        leak, or malposition; superficial
Thrombosis/embolism             Injury, poisoning and    Vascular access                                                infection; antibiotics or device
(vascular access-related)       procedural complications complication                                -                  replacement indicated



                                Injury, poisoning and                               Asymptomatic diagnostic finding;    Symptomatic (e.g., claudication);
Vessel injury-vein Other NOS    procedural complications Venous injury              intervention not indicated          repair or revision not indicated



                                                                                    Incisional separation of <=25% of
Wound complication, non-        Injury, poisoning and                               wound, no deeper than superficial   Incisional separation >25% of
infectious                      procedural complications Wound complication         fascia                              wound; local care indicated




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      CTCAE v3.0 Term                    SOC               Proposed AE Term                 Proposed Grade 1                    Proposed Grade 2




                                                                                                                        Incisional separation >25% of
                                                                                                                        wound with local care;
                                                                                    Incisional separation of <=25% of   asymptomatic hernia or
Wound complication, non-       Injury, poisoning and                                wound, no deeper than superficial   symptomatic hernia without
infectious                     procedural complications Wound dehiscence            fascia                              evidence of strangulation
                                                        Activated partial
PTT (Partial Thromboplastin                             thromboplastin time
Time)                          Investigations           prolonged                   >1 - 1.5 x ULN                      >1.5 - 2.5 X ULN

ALT, SGPT (serum glutamic                              Alanine aminotransferase
pyruvic transaminase)          Investigations          increased                    >ULN - 2.5 x ULN                    >2.5 - 5.0 x ULN
                                                       Alkaline phosphatase
Alkaline phosphatase           Investigations          increased                    >ULN - 2.5 x ULN                    >2.5 - 5.0 x ULN

AST, SGOT(serum glutamic                               Aspartate aminotransferase
oxaloacetic transaminase)      Investigations          increased                  >ULN - 2.5 x ULN                      >2.5 - 5.0 x ULN
Neuroendocrine: ADH                                                               Asymptomatic; clinical or
secretion abnormality (e.g.,                           Blood antidiuretic hormone diagnostic observations only;         Symptomatic; medical intervention
SIADH or low ADH)              Investigations          abnormal                   intervention not indicated            indicated
                                                                                    Asymptomatic; clinical or
Neuroendocrine: ACTH                                   Blood corticotrophin         diagnostic observations only;       Symptomatic; medical intervention
deficiency                     Investigations          decreased                    intervention not indicated          indicated
Neuroendocrine:                                                                     Asymptomatic; clinical or
gonadotropin secretion                                 Blood gonadotrophin          diagnostic observations only;       Symptomatic; medical intervention
abnormality                    Investigations          abnormal                     intervention not indicated          indicated; limiting instrumental ADL
                                                                                    Asymptomatic; clinical or
Neuroendocrine: prolactin                                                           diagnostic observations only;       Moderate symptoms; limiting
hormone secretion abnormality Investigations           Blood prolactin abnormal     intervention not indicated          instrumental ADL

Short stature                  Investigations          Body height below normal     up to 10% below normal              > 10% below normal



                                                                                 3-5 units below lower limit of         6-8 units below lower limit of
                                                                                 normal, or for follow-up, a            normal, or for follow-up, an
                                                                                 decrease of 3-5 units                  asymptomatic decrease of >5-8
Carbon monoxide diffusion                              Carbon monoxide diffusing (ml/sec/mmHg) below the baseline       units (ml/sec/mmHg) below the
capacity (DL(co))              Investigations          capacity decreased        value                                  baseline value
                                                                                  Levels above the upper limit of
                                                                                  normal and below the level of
                                                                                  myocardial infarction as defined by
Cardiac troponin I (cTnI)      Investigations          Cardiac troponin increased the manufacturer                                         -




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      CTCAE v3.0 Term                     SOC        Proposed AE Term               Proposed Grade 1                      Proposed Grade 2
                                                 CD4 lymphocytes            <LLN - 500/mm(3) <LLN - 0.5 x         <500 - 200/mm(3) <0.5 - 0.2 x
CD4 count                       Investigations   decreased                  10e9 /L                               10e9 /L

CPK (creatine phosphokinase) Investigations      CPK increased              >ULN - 2.5 x ULN                      >2.5 x ULN - 5 x ULN
                                                                            >1 - 1.5 x baseline; >ULN - 1.5 x     >1.5 - 3.0 x baseline; >1.5 - 3.0 x
Creatinine                      Investigations   Creatinine increased       ULN                                   ULN




                                                 Electrocardiogram QT
                                                 corrected interval
Prolonged QTc interval          Investigations   prolonged                  QTc 450 - <=480 msec                  QTc 481 - <=500 msec

                                                                            <1.0 - 0.75 x LLN or <25%             <0.75 - 0.5 x LLN or 25 - <50%
Fibrinogen                      Investigations   Fibrinogen decreased       decrease from baseline                decrease from baseline
                                                                                                                  60-69% LLN; change PC20 0.126-
                                                 Forced expiratory volume   70%-LLN; change 10-19%; PC20          0.5 mg/ml; limiting instrumental
FEV(1)                          Investigations   decreased                  0.51-8 mg/ml                          ADL
GGT (gamma-Glutamyl
transpeptidase)                 Investigations   GGT increased              >ULN - 2.5 x ULN                      >2.5 - 5.0 x ULN
                                                                         Asymptomatic; clinical or
Neuroendocrine: growth                                                   diagnostic observations only;            Symptomatic; medical intervention
hormone secretion abnormality Investigations     Growth hormone abnormal intervention not indicated               indicated; limiting instrumental ADL
Haptoglobin                   Investigations     Haptoglobin decreased   <LLN                                                        -

                                                                            <LLN - 10.0 g/dL <LLN - 6.2           <10.0 - 8.0 g/dL <6.2 - 4.9 mmol/L
Hemoglobin                      Investigations   Hemoglobin decreased       mmol/L <LLN - 100 g/L                 <100 - 80g/L
                                                                            Increase in >0-2 Gm/dl above ULN Increase in >2-4 Gm/dl above ULN
                                                                            or above baseline if baseline is or above baseline if baseline is
Hemoglobin                      Investigations   Hemoglobin increased       above ULN                        above ULN

INR (International Normalized                                               >1 - 1.5 x ULN or times above         >1.5 - 2.5 x ULN or times above
Ratio of prothrombin time)      Investigations   INR Increased              baseline if on anticoagulation        baseline if on anticoagulation




                                                                                                                  Moderate; minimal, local or
                                                                            Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Blood/Bone Marrow - Other                        Investigations, Other      clinical or diagnostic observations   limiting age-appropriate
(Specify, __)                   Investigations   specify                    only; intervention not indicated      instrumental ADL



Lipase                          Investigations   Lipase increased           >ULN - 1.5 x ULN                      >1.5 - 2.0 x ULN




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      CTCAE v3.0 Term                    SOC                    Proposed AE Term              Proposed Grade 1                        Proposed Grade 2

Pancreas, exocrine enzyme                                   Pancreatic enzymes                                              Increase in stool frequency, bulk,
deficiency                     Investigations               decreased                 < LLN and asymptomatic                or odor; steatorrhea



Amylase                        Investigations               Serum amylase increased   >ULN - 1.5 x ULN                      >1.5 - 2.0 x ULN

                                                                                                                            <75 - 50% of predicted value;
Vital capacity                 Investigations               Vital capacity abnormal   90 - 75% of predicted value           limiting instrumental ADL
Weight gain                    Investigations               Weight gain               5 - <10% from baseline                10 - <20% from baseline
                                                                                      5 to <10% from baseline;              10 - <20% from baseline;
Weight loss                    Investigations               Weight loss               intervention not indicated            nutritional support indicated
Acidosis (metabolic or         Metabolism and nutrition
respiratory)                   disorders                    Acidosis                  pH <normal, but =>7.3                                    -

Alcohol intolerance syndrome   Metabolism and nutrition
(antabuse-like syndrome)       disorders                    Alcohol intolerance                         -                   Present
Alkalosis (metabolic or        Metabolism and nutrition
respiratory)                   disorders                    Alkalosis                 pH >normal, but <=7.5                                    -

                                                                                                                            Oral intake altered without
                                                                                                                            significant weight loss or
                               Metabolism and nutrition                               Loss of appetite without alteration   malnutrition; oral nutritional
Anorexia                       disorders                    Anorexia                  in eating habits                      supplements indicated
                                                                                      Increased oral fluids indicated; dry
                               Metabolism and nutrition                               mucous membranes; diminished
Dehydration                    disorders                    Dehydration               skin turgor                          IV fluids indicated <24 hrs
                                                                                      Asymptomatic; clinical or
Pancreatic endocrine:          Metabolism and nutrition                               diagnostic observations only;         Symptomatic; dietary modification
glucose intolerance            disorders                    Glucose intolerance       intervention not indicated            or oral agent indicated

                                                                                      >ULN - 11.5 mg/dL >ULN - 2.9          >11.5 - 12.5 mg/dL >2.9 - 3.1
Calcium, serum-high            Metabolism   and nutrition                             mmol/L Ionized calcium >ULN -         mmol/L Ionized calcium >1.5 -
(hypercalcemia)                disorders                    Hypercalcemia             1.5 mmol/L; Asymptomatic              1.6 mmol/L; Symptomatic
Cholesterol, serum-high        Metabolism   and nutrition                             >ULN - 300 mg/dL >ULN - 7.75          >300 - 400 mg/dL >7.75 - 10.34
(hypercholesteremia)           disorders                    Hypercholesteremia        mmol/L                                mmol/L
Glucose, serum-high            Metabolism   and nutrition                             >ULN - 160 mg/dL >ULN - 8.9           >160 - 250 mg/dL >8.9 - 13.9
(hyperglycemia)                disorders                    Hyperglycemia             mmol/L                                mmol/L
Potassium, serum-high          Metabolism   and nutrition
(hyperkalemia)                 disorders                    Hyperkalemia              >ULN - 5.5 mmol/L                     >5.5 - 6.0 mmol/L
Magnesium, serum-high          Metabolism   and nutrition                             >ULN - 3.0 mg/dL >ULN - 1.23
(hypermagnesemia)              disorders                    Hypermagnesemia           mmol/L                                                   -
Sodium, serum-high             Metabolism   and nutrition
(hypernatremia)                disorders                    Hypernatremia             >ULN - 150 mmol/L                     >150 - 155 mmol/L




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      CTCAE v3.0 Term                  SOC                    Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2
                                                                                                                         >300mg/dl -
Triglyceride, serum-high     Metabolism and nutrition                                  150mg/dl - 300mg/dl (1.71mmol/L - 500mg/dl(>3.42mmol/L-
(hypertriglyceridemia)       disorders                    Hypertriglyceridemia          3.42mmol/L)                      5.7mmol/L)

Uric acid, serum-high        Metabolism and nutrition                                  >ULN - 10 mg/dL <=0.59 mmol/L
(hyperuricemia)              disorders                    Hyperuricemia                without physiologic consequences                       -

Albumin, serum-low           Metabolism and nutrition
(hypoalbuminemia)            disorders                    Hypoalbuminemia              <LLN - 3 g/dL <LLN - 30 g/L           <3 - 2 g/dL <30 - 20 g/L

                                                                                       <LLN - 8.0 mg/dL <LLN - 2.0           <8.0 - 7.0 mg/dL <2.0 - 1.75
Calcium, serum-low           Metabolism and nutrition                                  mmol/L Ionized calcium <LLN -         mmol/L Ionized calcium <1.0 -
(hypocalcemia)               disorders                    Hypocalcemia                 1.0 mmol/L; Asymptomatic              0.9 mmol/L; Symptomatic
Glucose, serum-low           Metabolism and nutrition                                  <LLN - 55 mg/dL <LLN - 3.0
(hypoglycemia)               disorders                    Hypoglycemia                 mmol/L                                <55 - 40 mg/dL <3.0 - 2.2 mmol/L

Potassium, serum-low         Metabolism   and nutrition                                                                 <LLN - 3.0 mmol/L; symptomatic;
(hypokalemia)                disorders                    Hypokalemia                  <LLN - 3.0 mmol/L; Asymptomatic, intervention indicated
Magnesium, serum-low         Metabolism   and nutrition                                <LLN - 1.2 mg/dL <LLN - 0.5
(hypomagnesemia)             disorders                    Hypomagnesemia               mmol/L                           <1.2 - 0.9 mg/dL <0.5 - 0.4 mmol/L
Sodium, serum-low            Metabolism   and nutrition
(hyponatremia)               disorders                    Hyponatremia                 <LLN - 130 mmol/L                                      -
Phosphate, serum-low         Metabolism   and nutrition                                <LLN - 2.5 mg/dL <LLN - 0.8
(hypophosphatemia)           disorders                    Hypophosphatemia             mmol/L                                <2.5 - 2.0 mg/dL <0.8 - 0.6 mmol/L

                             Metabolism and nutrition                                                                        Moderate symptoms; intervention
Iron overload                disorders                    Iron overload                                  -                   not indicated




                                                                                                                             Moderate; minimal, local or
                                                                                       Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                             Metabolism and nutrition     Metabolism and nutrition     clinical or diagnostic observations   limiting age-appropriate
                             disorders                    disorders - other, specify   only; intervention not indicated      instrumental ADL
                             Metabolism and nutrition
Obesity                      disorders                    Obesity                                        -                   BMI 25 - 29.9 kg/m(2)

                             Metabolism and nutrition
Tumor lysis syndrome         disorders                    Tumor lysis syndrome                           -                                    -

                             Musculoskeletal and                                                                             Local wound care; medical
                             connective tissue            Abdominal soft tissue                                              intervention indicated (e.g.,
Soft tissue necrosis Abdomen disorders                    necrosis                                       -                   dressings or topical medications)




45                                                                                                                                                                 1/6/2011
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      CTCAE v3.0 Term                    SOC               Proposed AE Term              Proposed Grade 1                     Proposed Grade 2
                                Musculoskeletal and
Musculoskeletal/Soft Tissue -   connective tissue                                                                     Moderate pain; limiting
Other (Specify, __)             disorders             Arthralgia                 Mild pain                            instrumental ADL



                                Musculoskeletal and                                                                   Moderate pain with inflammation,
                                connective tissue                                Mild pain with inflammation,         erythema, or joint swelling; limiting
Arthritis (non-septic)          disorders             Arthritis                  erythema, or joint swelling          instrumental ADL
                                Musculoskeletal and                              Asymptomatic; clinical or
Osteonecrosis (avascular        connective tissue                                diagnostic observations only;        Symptomatic; limiting instrumental
necrosis)                       disorders             Avascular necrosis         intervention not indicated           ADL
                                Musculoskeletal and
                                connective tissue                                                                     Moderate pain; limiting
Pain Back                       disorders             Back pain                  Mild pain                            instrumental ADL
                                Musculoskeletal and
                                connective tissue                                                                     Moderate pain; limiting
Pain Bone                       disorders             Bone pain                  Mild pain                            instrumental ADL
                                Musculoskeletal and
                                connective tissue                                                                     Moderate pain; limiting
Pain Buttock                    disorders             Buttock Pain               Mild pain                            instrumental ADL
                                Musculoskeletal and
                                connective tissue                                                                     Moderate pain; limiting
Pain Chest wall                 disorders             Chest wall pain            Mild pain                            instrumental ADL
                                Musculoskeletal and                              Asymptomatic; clinical or
                                connective tissue                                diagnostic observations only;        Symptomatic; limiting instrumental
Exostosis                       disorders             Exostosis                  intervention not indicated           ADL



                                Musculoskeletal and                              Mild induration, able to move skin Moderate induration, able to slide
Fibrosis-deep connective        connective tissue     Fibrosis deep connective   parallel to plane (sliding) and     skin, unable to pinch skin; limiting
tissue                          disorders             tissue                     perpendicular to skin (pinching up) instrumental ADL
                                Musculoskeletal and
                                connective tissue                                                                     Moderate pain; limiting
Pain Kidney                     disorders             Flank pain                 Mild pain                            instrumental ADL

Muscle weakness,
generalized or specific area  Musculoskeletal and                                Symptomatic; weakness perceived Symptomatic; weakness evident
(not due to neuropathy) Whole connective tissue       Generalized muscle         by patient but not evident on   on physical exam; weakness
body/generalized              disorders               weakness                   physical exam                   limiting instrumental ADL
                                                                                                                      Reduction in growth velocity by 30-
                                                                                                                      49% ideally measured over the
                                Musculoskeletal and                              Reduction in growth velocity by 10 - period of a year0 - 49% reduction
Growth velocity (reduction in   connective tissue                                 29% ideally measured over the       in growth from the baseline growth
growth velocity)                disorders             Growth suppression         period of a year                     curve




46                                                                                                                                                            1/6/2011
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      CTCAE v3.0 Term                    SOC              Proposed AE Term                Proposed Grade 1                       Proposed Grade 2

                                Musculoskeletal and                                                                      Local wound care; medical
                                connective tissue                                                                        intervention indicated (e.g.,
Soft tissue necrosis Head       disorders             Head soft tissue necrosis                     -                    dressings or topical medications)
                                Musculoskeletal and                               Asymptomatic; clinical or
                                connective tissue                                 diagnostic observations only;          Symptomatic; limiting instrumental
Joint-effusion                  disorders             Joint effusion              intervention not indicated             ADL
                                Musculoskeletal and
                                connective tissue                                                                        Moderate pain; limiting
Pain Joint                      disorders             Joint pain                  Mild pain                              instrumental ADL

                               Musculoskeletal and                                Decreased range of motion (ROM) Decreased range of motion (ROM)
                               connective tissue      Joint range of motion       limiting athletic activity; <=25% limiting instrumental ADL; >25 -
Cervical spine-range of motion disorders              decreased                   loss of ROM                       50% decrease in ROM
                               Musculoskeletal and
                               connective tissue      Joint range of motion       Mild restriction of rotation or        Rotation <60 degrees to right or
Cervical spine-range of motion disorders              decreased cervical spine    flexion between 60 - 70 degrees        left; <60 degrees of flexion



                                                                                                                         Pain with range of motion (ROM)
                             Musculoskeletal and                                  Stiffness; difficulty bending to the   in lumbar spine; requires a
                             connective tissue        Joint range of motion       floor to pick up a very light object   reaching aid to pick up a very light
Lumbar spine-range of motion disorders                decreased lumbar spine      but able to do athletic activity       object from the floor
                                Musculoskeletal and                               Asymptomatic; clinical or
Bone growth: spine              connective tissue                                 diagnostic observations only;
kyphosis/lordosis               disorders             Kyphosis                    intervention not indicated             Moderate accentuation
                                Musculoskeletal and                               Asymptomatic; clinical or
Bone growth: spine              connective tissue                                 diagnostic observations only;          Moderate accentuation; limiting
kyphosis/lordosis               disorders             Lordosis                    intervention not indicated             instrumental ADL
Muscle weakness,
generalized or specific area    Musculoskeletal and                              Symptomatic; weakness perceived Symptomatic; weakness evident
(not due to neuropathy) Left-   connective tissue                                by patient but not evident on   on physical exam; weakness
sided                           disorders             Muscle weakness left-sided physical exam                   limiting instrumental ADL

Muscle weakness,
generalized or specific area    Musculoskeletal and                               Symptomatic; weakness perceived Symptomatic; weakness evident
(not due to neuropathy)         connective tissue     Muscle weakness lower       by patient but not evident on   on physical exam; weakness
Extremity-lower                 disorders             limb                        physical exam                   limiting instrumental ADL
Muscle weakness,
generalized or specific area   Musculoskeletal and                                Symptomatic; weakness perceived Symptomatic; weakness evident
(not due to neuropathy) Right- connective tissue      Muscle weakness right-      by patient but not evident on   on physical exam; weakness
sided                          disorders              sided                       physical exam                   limiting instrumental ADL




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      CTCAE v3.0 Term                    SOC              Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2

Muscle weakness,                Musculoskeletal and                                Symptomatic; weakness perceived Symptomatic; weakness evident
generalized or specific area    connective tissue                                  by patient but not evident on   on physical exam; weakness
(not due to neuropathy) Trunk   disorders             Muscle weakness trunk        physical exam                   limiting instrumental ADL

Muscle weakness,
generalized or specific area    Musculoskeletal and                                Symptomatic; weakness perceived Symptomatic; weakness evident
(not due to neuropathy)         connective tissue     Muscle weakness upper        by patient but not evident on   on physical exam; weakness
Extremity-upper                 disorders             limb                         physical exam                   limiting instrumental ADL




                                                                                                                         Moderate; minimal, local or
                                Musculoskeletal and   Musculoskeletal and          Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Musculoskeletal/Soft Tissue -   connective tissue     connective tissue - Other,   clinical or diagnostic observations   limiting age-appropriate
Other (Specify, __)             disorders             specify                      only; intervention not indicated      instrumental ADL

                                                                                                                         Deformity, hypoplasia, or
                                Musculoskeletal and                                                                      asymmetry able to be remediated
                                connective tissue                                  Cosmetically and functionally         by prosthesis (e.g., shoe insert) or
Muscular/skeletal hypoplasia    disorders             Musculoskeletal deformity    insignificant hypoplasia              covered by clothing
                                Musculoskeletal and
                                connective tissue                                                                        Moderate pain; limiting
Pain Muscle                     disorders             Myalgia                      Mild pain                             instrumental ADL
Myositis                        Musculoskeletal and                                                                      Moderate pain associated with
(inflammation/damage of         connective tissue                                                                        weakness; pain limiting
muscle)                         disorders             Myositis                     Mild pain                             instrumental ADL
                                Musculoskeletal and
                                connective tissue                                                                        Moderate pain; limiting
Pain Neck                       disorders             Neck pain                    Mild pain                             instrumental ADL

                                Musculoskeletal and                                                                      Local wound care; medical
                                connective tissue                                                                        intervention indicated (e.g.,
Soft tissue necrosis Neck       disorders             Neck soft tissue necrosis                      -                   dressings or topical medications)

                                Musculoskeletal and                                Asymptomatic; clinical or             Symptomatic; medical intervention
Osteonecrosis (avascular        connective tissue                                  diagnostic observations only;         indicated (e.g., topical agents);
necrosis)                       disorders             Osteonecrosis                intervention not indicated            limiting instrumental ADL
                                                                                   Radiologic evidence of
                                                                                   osteoporosis or Bone Mineral
                                Musculoskeletal and                                Density (BMD) t-score -1 to -2.5      BMD t-score < -2.5; loss of height
                                connective tissue                                  (osteopenia); no loss of height or    <2 cm; anti-osteoporotic therapy
Osteoporosis                    disorders             Osteoporosis                 intervention indicated                indicated




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      CTCAE v3.0 Term                         SOC                Proposed AE Term                  Proposed Grade 1                     Proposed Grade 2
                                   Musculoskeletal and
                                   connective tissue
Osteoporosis                       disorders                 Osteoporotic fracture                          -                                     -
                                   Musculoskeletal and
                                   connective tissue                                                                            Moderate pain; limiting
Pain Extremity-limb                disorders                 Pain in extremity             Mild pain                            instrumental ADL

                                   Musculoskeletal and                                                                          Local wound care; medical
                                   connective tissue                                                                            intervention indicated (e.g.,
Soft tissue necrosis Pelvic        disorders                 Pelvic soft tissue necrosis                    -                   dressings or topical medications)



                                   Musculoskeletal and                                                                          >20 - 45 degrees; visible by
                                   connective tissue                                       <=20 degrees; clinically             forward flexion; limiting
Bone: spine-scoliosis              disorders                 Scoliosis                     undetectable                         instrumental ADL

                                Musculoskeletal and                                                                             Local wound care; medical
Soft tissue necrosis Extremity- connective tissue            Soft tissue necrosis lower                                         intervention indicated (e.g.,
lower                           disorders                    limb                                           -                   dressings or topical medications)

                                Musculoskeletal and                                                                             Local wound care; medical
Soft tissue necrosis Extremity- connective tissue            Soft tissue necrosis upper                                         intervention indicated (e.g.,
upper                           disorders                    limb                                           -                   dressings or topical medications)



                                   Musculoskeletal and                                     Mild induration, able to move skin Moderate induration, able to slide
                                   connective tissue         Superficial soft tissue       parallel to plane (sliding) and     skin, unable to pinch skin; limiting
Fibrosis-cosmesis                  disorders                 fibrosis                      perpendicular to skin (pinching up) instrumental ADL
                                   Musculoskeletal and                                                                          Decreased range of motion
Trismus (difficulty, restriction   connective tissue                                       Decreased range of motion            requiring small bites, soft foods or
or pain when opening mouth)        disorders                 Trismus                       without impaired eating              purees

                                   Musculoskeletal and                                                                          Moderate length discrepancy 2 - 5
Bone growth: limb length           connective tissue                                                                            cm; shoe lift indicated; limiting
discrepancy                        disorders                 Unequal limb length           Mild length discrepancy <2 cm        instrumental ADL
                                   Musculoskeletal and                                                                          Some compensation from
                                   connective tissue                                                                            unaffected limb; limiting
Extremity-upper (function)         disorders                 Upper extremity dysfunction                    -                   instrumental ADL
                                   Neoplasms benign,
                                   malignant and
Pleural effusion (non-             unspecified (incl cysts
malignant)                         and polyps)               Malignant pleural effusion    < 1000 ml, asymptomatic              < 1000 ml, symptomatic




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      CTCAE v3.0 Term                    SOC                Proposed AE Term                Proposed Grade 1                      Proposed Grade 2
                              Neoplasms benign,
                              malignant and
                              unspecified (incl cysts
                              and polyps)               Myelodysplastic syndrome                      -                                     -




                              Neoplasms benign,         Neoplasms benign,                                                 Moderate; minimal, local or
                              malignant and             malignant and unspecified   Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                              unspecified (incl cysts   (incl cysts and polyps) -   clinical or diagnostic observations   limiting age-appropriate
                              and polyps)               other, specify              only; intervention not indicated      instrumental ADL
                              Neoplasms benign,
Secondary Malignancy -        malignant and
possibly related to cancer    unspecified (incl cysts   Treatment related
treatment (Specify, __)       and polyps)               secondary malignancy                          -                                     -
                              Neoplasms benign,
                              malignant and
                              unspecified (incl cysts                                                                     Moderate pain; limiting
Pain Tumor pain               and polyps)               Tumor pain                  Mild pain                             instrumental ADL
                                                                                    Asymptomatic; clinical or
Neuropathy: cranial CN VI     Nervous system                                        diagnostic observations only;         Moderate symptoms; limiting
Lateral deviation of eye      disorders                 Abducens nerve disorder     intervention not indicated            instrumental ADL
Neuropathy: cranial CN XI                                                           Asymptomatic; clinical or
Motor-sternomastoid and       Nervous system                                        diagnostic observations only;         Moderate symptoms; limiting
trapezius                     disorders                 Accessory nerve disorder    intervention not indicated            instrumental ADL
                                                                                    Asymptomatic; clinical or
Neuropathy: cranial CN VIII   Nervous system            Acoustic nerve disorder     diagnostic observations only;         Moderate symptoms; limiting
Hearing and balance           disorders                 NOS                         intervention not indicated            instrumental ADL
                                                                                                                          Moderate restlessness or
                              Nervous system                                        Mild restlessness or increased        increased motor activity; limiting
Mood alteration Agitation     disorders                 Akathisia                   motor activity                        instrumental ADL
                              Nervous system                                                                              Moderate; short term memory
Memory impairment             disorders                 Amnesia                     Mild; transient memory loss           loss; limiting instrumental ADL
Speech impairment (e.g.,      Nervous system
dysphasia or aphasia)         disorders                 Aphonia                                       -                                     -

Arachnoiditis/meningismus/rad Nervous system                                                                              Moderate symptoms; limiting
iculitis                      disorders                 Arachnoiditis               Mild symptoms                         instrumental ADL
                                                                                    Asymptomatic; clinical or
                              Nervous system                                        diagnostic observations only;         Moderate symptoms; limiting
Ataxia (incoordination)       disorders                 Ataxia                      intervention not indicated            instrumental ADL
                                                                                    Asymptomatic; clinical or
                              Nervous system                                        diagnostic observations only;         Moderate symptoms; limiting
Brachial plexopathy           disorders                 Brachial plexopathy         intervention not indicated            instrumental ADL




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      CTCAE v3.0 Term                   SOC          Proposed AE Term                 Proposed Grade 1                     Proposed Grade 2
                                                                              Asymptomatic; clinical or
CNS necrosis/cystic            Nervous system    Central nervous system       diagnostic observations only;       Moderate symptoms;
progression                    disorders         necrosis                     intervention not indicated          corticosteroids indicated


                                                                                                                  Post-craniotomy: moderate
                                                                                                                  symptoms; medical intervention
                                                                             Post-craniotomy: asymptomatic;       indicated; Post- lumbar puncture:
                                Nervous system                               Post- lumbar puncture: transient     persistent moderate symptoms;
Leak, cerebrospinal fluid (CSF) disorders        Cerebrospinal fluid leakage headache; postural care indicated    blood patch indicated
                                                                                                                  Moderate cognitive disability;
                                                                              Mild cognitive disability; not      interfering with work/school/life
                                                                              interfering with work/school/life   performance but capable of
                                                                              performance; specialized            independent living; specialized
                               Nervous system                                 educational services/devices not    resources on part-time basis
Cognitive disturbance          disorders         Cognitive disturbance        indicated                           indicated

                                                                                                                  Moderate impairment in attention
                               Nervous system                                 Mild inattention or level of        or level of concentration; limiting
Memory impairment              disorders         Concentration impairment     concentration                       instrumental ADL
Somnolence/depressed level     Nervous system    Depressed level of                                               Sedation; slow response to stimuli;
of consciousness               disorders         consciousness                Decreased level of alterness        limiting instrumental ADL
                                                                                                                  Moderate unsteadiness or
                               Nervous system                                 Mild unsteadiness or sensation of   sensation of movement; limiting
Dizziness                      disorders         Dizziness                    movement                            instrumental ADL
Speech impairment (e.g.,       Nervous system                                                                     Moderate impairment of
dysphasia or aphasia)          disorders         Dysarthria                   Mild slurred speech                 articulation or slurred speech
                                                                                                                  Moderate sensory alteration or
                               Nervous system                                 Asymptomatic; loss of deep          paresthesia; limiting instrumental
Laryngeal nerve dysfunction    disorders         Dysesthesia                  tendon reflexes or paresthesia      ADL

                                                                                                                  Altered taste with change in diet
                               Nervous system                                                                     (e.g., oral supplements); noxious
Taste alteration (dysgeusia)   disorders         Dysgeusia                    Altered taste but no change in diet or unpleasant taste; loss of taste

                                                                              Awareness of receptive or           Moderate receptive or expressive
Speech impairment (e.g.,       Nervous system                                 expressive characteristics; not     characteristics; impairing ability to
dysphasia or aphasia)          disorders         Dysphasia                    impairing ability to communicate    communicate spontaneously

                               Nervous system
Hydrocephalus                  disorders         Edema cerebral                                                                      -

                               Nervous system                                                                     Moderate symptoms; limiting
Encephalopathy                 disorders         Encephalopathy               Mild symptoms                       instrumental ADL




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      CTCAE v3.0 Term                   SOC         Proposed AE Term                 Proposed Grade 1                   Proposed Grade 2

Extrapyramidal/involuntary     Nervous system                                                                   Moderate involuntary movements;
movement/restlessness          disorders        Extrapyramidal disorder      Mild involuntary movements         limiting instrumental ADL

Muscle weakness,                                                             Asymptomatic; clinical or
generalized or specific area   Nervous system                                diagnostic observations only;      Moderate symptoms; limiting
(not due to neuropathy) Facial disorders        Facial muscle weakness       intervention not indicated         instrumental ADL
                                                                             Asymptomatic; clinical or
Neuropathy: cranial CN VII     Nervous system                                diagnostic observations only;      Moderate symptoms; limiting
Motor-face; Sensory-taste      disorders        Facial nerve disorder        intervention not indicated         instrumental ADL
Neuropathy: cranial CN IX                                                    Asymptomatic; clinical or
Motor-pharynx; Sensory-ear,    Nervous system   Glossopharyngeal nerve       diagnostic observations only;      Moderate symptoms; limiting
pharynx, tongue                disorders        disorder                     intervention not indicated         instrumental ADL
                               Nervous system                                                                   Moderate pain; limiting
Pain Head/headache             disorders        Headache                     Mild pain                          instrumental ADL

                                                                                                                Lethargy; mild disoriention; slurred
                               Nervous system                                Mild inattention; mild tremor or   speech; subtle personality change;
Encephalopathy                 disorders        Hepatic encephalopathy       anxiety                            inappropriate behavior
                                                                             Asymptomatic; clinical or
                               Nervous system                                diagnostic observations only;      Moderate symptoms; intervention
Hydrocephalus                  disorders        Hydrocephalus                intervention not indicated         not indicated
                               Nervous system
Insomnia                       disorders        Hypersomnia                  Mild increased need for sleep      Moderate increased need for sleep
                                                                           Asymptomatic; clinical or
Neuropathy: cranial CN XII     Nervous system                              diagnostic observations only;        Moderate symptoms; limiting
Motor-tongue                   disorders        Hypoglossal nerve disorder intervention not indicated           instrumental ADL

                                                                             Asymptomatic; clinical or
                               Nervous system                                diagnostic observations only;      Moderate symptoms; medical
Hemorrhage, CNS                disorders        Intracranial hemorrhage      intervention not indicated         intervention indicated
                                                                             Asymptomatic; clinical or
                             Nervous system                                  diagnostic observations only;
CNS cerebrovascular ischemia disorders          Ischemia cerebrovascular     intervention not indicated         Moderate symptoms
Neuropathy: cranial CN IV                                                    Asymptomatic; clinical or
Downward, inward movement      Nervous system                                diagnostic observations only;      Moderate symptoms; limiting
of eye                         disorders        IVth nerve disorder          intervention not indicated         instrumental ADL
Fatigue (asthenia, lethargy,   Nervous system                                Mild symptoms; reduced alertness   Moderate symptoms; limiting
malaise)                       disorders        Lethargy                     and awareness                      instrumental ADL




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      CTCAE v3.0 Term                    SOC         Proposed AE Term                Proposed Grade 1                      Proposed Grade 2


                                                                                                                   Moderate symtoms; focal
                                                                             Asymptomatic; small focal             T2/FLAIR hyperintensities,
                                                                             T2/FLAIR hyperintensities;            involving periventricular white
                                                                             involving periventricular white       matter extending into centrum
                                                                             matter or < 1/3 of susceptible        semiovale or involving 1/3 to 2/3 of
                                                                             areas of cerebrum +/- mild            susceptible areas of cerebrum +/-
Leukoencephalopathy             Nervous system                               increase in subrachnoid space         moderate increase in SAS and/or
(radiographic findings)         disorders        Leukoencephalopathy         (SAS) and/or mild ventriculomegaly    moderate ventriculomegaly
                                Nervous system                                                                     Moderate memory impairment;
Memory impairment               disorders        Memory impairment           Mild memory impairment                limiting instrumental ADL

Arachnoiditis/meningismus/rad   Nervous system                                                                     Moderate symptoms; limiting
iculitis                        disorders        Meningismus                 Mild symptoms                         instrumental ADL
Extrapyramidal/involuntary      Nervous system                                                                     Moderate symptoms; limiting
movement/restlessness           disorders        Movements involuntary       Mild symptoms                         instrumental ADL

                                Nervous system                               Asymptomatic; mild signs (e.g.,       Moderate weakness or sensory
Myelitis                        disorders        Myelitis                    Babinski's or Lhermitte's sign)       loss; limiting instrumental ADL




                                                                                                                   Moderate; minimal, local or
                                                                             Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                                Nervous system   Nervous system - Other,     clinical or diagnostic observations   limiting age-appropriate
Neurology - Other (Specify, __) disorders        specify                     only; intervention not indicated      instrumental ADL
Pain Neuralgia/peripheral       Nervous system                                                                     Moderate pain; limiting
nerve                           disorders        Neuralgia                   Mild pain                             instrumental ADL
                                Nervous system                                                                     Moderate symptoms; limiting
Nystagmus                       disorders        Nystagmus                                     -                   instrumental ADL
Neuropathy: cranial CN III                                                 Asymptomatic; clinical or
Pupil, upper eyelid, extra      Nervous system                             diagnostic observations only;           Moderate symptoms; limiting
ocular movements                disorders        Oculomotor nerve disorder intervention not indicated              instrumental ADL

                               Nervous system                                                                      Moderate symptoms; limiting
Neuropathy: cranial CN I Smell disorders         Olfactory nerve disorder                      -                   instrumental ADL
                               Nervous system                                                                      Moderate symptoms; limiting
Neuropathy: sensory            disorders         Paresthesia                 Mild symptoms                         instrumental ADL
                                                                             Asymptomatic; clinical or
                                Nervous system   Peripheral motor            diagnostic observations only;         Moderate symptoms; limiting
Neuropathy: motor               disorders        neuropathy                  intervention not indicated            instrumental ADL

                                Nervous system   Peripheral sensory          Asymptomatic; loss of deep            Moderate symptoms; limiting
Neuropathy: sensory             disorders        neuropathy                  tendon reflexes or paresthesia        instrumental ADL




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      CTCAE v3.0 Term                    SOC         Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2

Pain Phantom (pain              Nervous system                                                                      Moderate pain; limiting
associated with missing limb)   disorders        Phantom pain                 Mild pain                             instrumental ADL
                                Nervous system
Syncope (fainting)              disorders        Presyncope                                     -                   Present (e.g., near fainting)


Pyramidal tract dysfunction
(e.g., increased tone,
hyperreflexia, positive                                                       Asymptomatic; clinical or
Babinski, decreased fine        Nervous system                                diagnostic observations only;         Moderate symptoms; limiting
motor coordination)             disorders        Pyramidal tract syndrome     intervention not indicated            instrumental ADL
                                                                                                                    Moderate symptoms; limiting
Arachnoiditis/meningismus/rad Nervous system                                                                        instrumental ADL; medical
iculitis                      disorders          Radiculitis                  Mild symptoms                         intervention indicated

                                                                              Asymptomatic; clinical or
                                Nervous system   Recurrent laryngeal nerve    diagnostic observations only;
Laryngeal nerve dysfunction     disorders        palsy                        intervention not indicated            Moderate symptoms
                                                 Reversible posterior         Asymptomatic; clinical or             Moderate symptoms; abnormal
Leukoencephalopathy             Nervous system   leukoencephalopathy          diagnostic observations only;         imaging studies; limiting
(radiographic findings)         disorders        syndrome                     intervention not indicated            instrumental ADL
                                Nervous system                                Brief partial seizure; no loss of
Seizure                         disorders        Seizure                      consciousness                         Brief generalized seizure
                                Nervous system                                                                      Moderate pain; limiting
Pain Sinus                      disorders        Sinus pain                   Mild pain                             instrumental ADL

Somnolence/depressed level      Nervous system                                Mild but more than usual              Moderate sedation; limiting
of consciousness                disorders        Somnolence                   drowsiness or sleepiness              instrumental ADL


Pyramidal tract dysfunction
(e.g., increased tone,
hyperreflexia, positive                                                                                             Moderate increase in muscle tone
Babinski, decreased fine        Nervous system                                Mild or slight increase in muscle     and increase in resistance through
motor coordination)             disorders        Spasticity                   tone                                  range of motion

                             Nervous system                                   Asymptomatic or mild neurologic       Moderate neurologic deficit;
CNS cerebrovascular ischemia disorders           Stroke                       deficit; radiographic findings only   symptoms > 24 hrs duration
                             Nervous system
Syncope (fainting)           disorders           Syncope                                        -                                     -

                                                                                                                    Moderate neurologic deficit with or
                             Nervous system                                   Asymptomatic or mild neurologic       without imaging confirmation;
CNS cerebrovascular ischemia disorders           Transient ischemic attacks   deficit; radiographic findings only   symptoms < 24 hrs duration
                             Nervous system                                                                         Moderate symptoms; limiting
Tremor                       disorders           Tremor                       Mild symptoms                         instrumental ADL



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      CTCAE v3.0 Term                     SOC                  Proposed AE Term                 Proposed Grade 1                       Proposed Grade 2
Neuropathy: cranial CN V                                                                Asymptomatic; clinical or
Motor-jaw muscles; Sensory-     Nervous system                                          diagnostic observations only;          Moderate symptoms; limiting
facial                          disorders                  Trigeminal nerve disorder    intervention not indicated             instrumental ADL
                                                                                        Asymptomatic; clinical or
Neuropathy: cranial CN X        Nervous system                                          diagnostic observations only;          Moderate symptoms; limiting
Motor-palate; pharynx, larynx   disorders                  Vagus nerve disorder         intervention not indicated             instrumental ADL

                                Nervous system
Vasovagal episode               disorders                  Vasovagal reaction                             -                                      -

                                Pregnancy, puerperium
                                and perinatal conditions   Fetal death                                    -                                      -

                                Pregnancy, puerperium                                                                          Less than 10% percentile of
                                and perinatal conditions   Fetal growth retardation                       -                    weight for gestational age




                                                           Pregnancy, puerperium        Asymptomatic or mild symptoms;         Moderate, local or noninvasive
                                Pregnancy, puerperium      and perinatal conditions -   clinical or diagnostic observations    intervention indicated; limiting
                                and perinatal conditions   other, specify               only; intervention not indicated       instrumental ADL

                                Pregnancy, puerperium                                   Delivery of a liveborn infant at 34+   Delivery of a liveborn infant at 28+
                                and perinatal conditions   Premature delivery           to 37 weeks gestation                  to 34 weeks gestation

                                Pregnancy, puerperium
                                and perinatal conditions   Unintended pregnancy                           -                                      -



Mood alteration Agitation       Psychiatric disorders      Agitation                    Mild mood alteration                   Moderate mood alteration

                                                                                        Inability to achieve orgasm not        Inability to achieve orgasm
Orgasmic dysfunction            Psychiatric disorders      Anorgasmia                   adversely affecting relationship       adversely affecting relationship

                                                                                        Mild symptoms; intervention not        Moderate symptoms; limiting
Mood alteration Anxiety         Psychiatric disorders      Anxiety                      indicated                              instrumental ADL

                                                                                                                               Moderate disorientation; limiting
Confusion                       Psychiatric disorders      Confusion                    Mild disorientation                    instrumental ADL

                                                                                        Delay in achieving orgasm not          Delay in achieving orgasm
Orgasmic dysfunction            Psychiatric disorders      Delayed orgasm               adversely affecting relationship       adversely affecting relationship




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         CTCAE v3.0 Term               SOC               Proposed AE Term              Proposed Grade 1                      Proposed Grade 2



                                                                                                                     Moderate and acute confusional
Confusion                    Psychiatric disorders   Delirium                  Mild acute confusional state          state; limiting instrumental ADL



Psychosis
(hallucinations/delusions)   Psychiatric disorders   Delusions                                   -                   Moderate delusional symptoms



                                                                                                                     Moderate depressive symptoms;
Mood alteration Depression   Psychiatric disorders   Depression                Mild depressive symptoms              limiting instrumental ADL

Mood alteration Euphoria     Psychiatric disorders   Euphoria                  Mild mood elevation                   Moderate mood elevation



Psychosis                                                                      Mild hallucinations (e.g.,
(hallucinations/delusions)   Psychiatric disorders   Hallucinations            perceptual distortions)               Moderate hallucinations

                                                                               Mild difficulty falling asleep,       Moderate difficulty falling asleep,
Insomnia                     Psychiatric disorders   Insomnia                  staying asleep or waking up early     staying asleep or waking up early

                                                                               Decrease in sexual interest not       Decrease in sexual interest
Libido                       Psychiatric disorders   Libido decreased          adversely affecting relationship      adversely affecting relationship
                                                                                                                    Moderate increase in sexual
                                                                               Mild increase in sexual interest not interest adversely affecting
Libido                       Psychiatric disorders   Libido increased          adversely affecting relationship     relationship
                                                                               Mild manic symptoms (e.g.,
                                                                               elevated mood, rapid thoughts,    Moderate manic symptoms (e.g.,
                                                                               faster speech, decreased need for relationship and work difficulties;
Mood alteration Euphoria     Psychiatric disorders   Mania                     sleep)                            poor hygiene)




Personality/behavioral       Psychiatric disorders   Personality change        Mild personality change               Moderate personality change




                                                                                                                     Moderate; minimal, local or
                                                                               Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                                                     Psychiatric disorders -   clinical or diagnostic observations   limiting age-appropriate
                             Psychiatric disorders   other, specify            only; intervention not indicated      instrumental ADL




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      CTCAE v3.0 Term                  SOC               Proposed AE Term             Proposed Grade 1                    Proposed Grade 2

                                                                                                                  Moderate psychotic symptoms
Psychosis                                                                                                         (e.g., disorganized speech;
(hallucinations/delusions)   Psychiatric disorders   Psychosis                Mild psychotic symptoms             impaired reality testing)
                                                                              Mild symptoms; intervention not     Moderate symptoms; limiting
Mood alteration Agitation    Psychiatric disorders   Restlessness             indicated                           instrumental ADL



                                                                              Increased thoughts of death but no Suicidal ideation with no specific
                             Psychiatric disorders   Suicidal Ideation        wish to kill oneself               plan or intent



                             Psychiatric disorders   Suicide attempt                            -                                    -

                             Renal and urinary                                Creatinine increase > 0.3 mg/dl;
Renal failure                disorders               Acute kidney injury      creatinine 1.5-2.0 x above baseline Creatinine 2-3x above baseline

                                                                                                                  extraperitoneal perforation
                             Renal and urinary                                                                    requiring management with
Perforation, GU Bladder      disorders               Bladder perforation      -                                   indwelling catheter
                             Renal and urinary
Bladder spasms               disorders               Bladder spasm            Intervention not indicated          Antispasmodics indicated
                             Renal and urinary                                >60-90 ml/min/1.7 m2 or
Glomerular filtration rate   disorders               Chronic kidney disease   proteinuria present                 >30-60 ml/min/1.7 m2


                                                                                                                  Moderate hematuria; moderate
                                                                                                                  increase in freqency, urgency,
                                                                              Microscopic hematuria; minimal      incontinence, dysuria, or nocturia;
                                                                              increase in freuqency, urgency,     placement of urinary catheter or
                             Renal and urinary                                dysuria, nocturia; new onset of     bladder irrigation indicated; limiting
Cystitis                     disorders               Cystitis noninfective    incontinence                        instrumental ADL




                                                                              Asymptomatic; clinical or           Symptomatic; urinary catheter or
                             Renal and urinary                                diagnostic observations only;       bladder irrigation indicated; limiting
Hemorrhage, GU Bladder       disorders               Hematuria                intervention not indicated          instrumental ADL
                                                                              Asymptomatic; clinical or
                             Renal and urinary                                diagnostic observations only;
Hemoglobinuria               disorders               Hemoglobinuria           intervention not indicated           -
                                                                                                                  2+ proteinuria; 1.0 - 3.4 g/d
                             Renal and urinary                                                                    (adults); urine P/C ratio 0.5-1.9
Proteinuria                  disorders               Proteinuria              1+ proteinuria ; < 1.0 g/24 hrs;    (pediatric)




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      CTCAE v3.0 Term                    SOC           Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2




                                                                                                                      Moderate; local or noninvasive
Renal/Genitourinary - Other    Renal and urinary   Renal and urinary - Other,   Mild or minor; marginal clinical      intervention indicated; limiting
(Specify, __)                  disorders           specify                      relevance                             instrumental ADL


                                                                                                               Symptomatic, alleviated with
                                                                                                               around the clock nonprescription
                                                                                Asymptomatic; minimal symptoms analgesics; use of enteral
                               Renal and urinary                                requiring occasional use of    antiemetics; use of any oral
                               disorders           Renal Calculi                nonprescription analgesics     narcotic analgesics
                                                                                Pain not interfering with activity;   Pain interfering with instrumental
                               Renal and urinary                                manage with nonpresciption            ADL; prescription medication
Pain Kidney                    disorders           Renal colic                  medication                            indicated




                               Renal and urinary                                Mild symptoms; intervention not       Moderate symptoms requiring pain
Hemorrhage, GU Kidney          disorders           Renal hemorrhage             indicated                             control and hematocrit monitoring




                                                                                                                      Noninvasive intervention indicated;
                               Renal and urinary                                                                      urinary cathether or suprapubic
Fistula, GU Kidney             disorders           Urinary Fistula              -                                     catheter placement



                               Renal and urinary                                Occasional (e.g., with coughing,    Spontaneous, pads indicated;
Incontinence, urinary          disorders           Urinary incontinence         sneezing, etc.), pads not indicated limiting instrumental ADL
                               Renal and urinary                                                                    Moderate pain; limiting
Pain Urethra                   disorders           Urinary Pain                 Mild pain                           instrumental ADL

                                                                                Symptomatic, patient able to void     Symptomatic, residual amounts
                                                                                with some residual not requiring      require placement of urinary,
Urinary retention (including   Renal and urinary                                urinary, suprapubic or intermittent   intermittent or suprapubic catheter
neurogenic bladder)            disorders           Urinary retention            catheter placement                    placement; requiring medication


                                                                                                                      Symptomatic but no
                                                                                                                      hydronephrosis, sepsis or renal
                                                                                                                      dysfunction; urethral dilation;
                                                                                                                      urinary or suprapubic cathether
                               Renal and urinary                                Asymptomatic,; clinical or            indicated; noninvasive
Obstruction, GU Ureter         disorders           Urinary tract obstruction    diagnostic observations only          management



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        CTCAE v3.0 Term                   SOC              Proposed AE Term                     Proposed Grade 1                   Proposed Grade 2
                                Renal and urinary
Urine color change              disorders              Urine discoloration            Present                              -
                                Reproductive system
Infertility/sterility           and breast disorders   Azospermia                                    -                                      -
                                Reproductive system                                   Minimal asymmetry; minimal           Asymmetry exists; moderate
Breast volume/hypoplasia        and breast disorders   Breast atrophy                 atrophy                              atrophy
                                Reproductive system                                                                        Moderate pain; limiting
Pain Breast                     and breast disorders   Breast pain                    Mild pain                            instrumental ADL
                                                                                                                           Moderate discomfort or pain
                                                                                      Mild discomfort or pain associated   associated with vaginal
                                                                                      with vaginal penetration;            penetration; discomfort or pain
                                Reproductive system                                   discomfort relieved with use of      partially relieved with use of
Orgasmic dysfunction            and breast disorders   Dyspareunia                    vaginal lubricants/estrogen          vaginal lubricants/estrogen
                                Reproductive system                                                                        Anejaculation or retrograde
Ejaculatory dysfunction         and breast disorders   Ejaculation disorder           Diminished ejaculation               ejaculation




                                                                                      Decrease in erectile function
                                                                                      (frequency/ rigidity of erections)   Decrease in erectile function
                                                                                      but intervention such as             (frequency/rigidity of erections),
                                                                                      medication or use of mechanical      erectile intervention indicated,
                                Reproductive system                                   device (e.g., penile pump) not       (e.g., medication or mechanical
Erectile dysfunction            and breast disorders   Erectile dysfunction           indicated                            devices such as penile pump)
                                                                                      Asymptomatic; clinical or
                               Reproductive system                                    diagnostic observations only;
Obstruction, GU Fallopian tube and breast disorders    Fallopian tube obstruction     intervention not indicated                             -



Stricture/stenosis (including                                                         Asymptomatic clinical or
anastomotic), GU Fallopian      Reproductive system                                   diagnostic observations only;        Symptomatic and intervention not
tube                            and breast disorders   Fallopian tube stenosis        intervention not indicated           indicated
                                                                                      Asymptomatic clinical or
Fistula, GU Genital tract-      Reproductive system                                   diagnostic observations only;        Symptomatic and intervention not
female                          and breast disorders   Female genital tract fistula   intervention not indicated           indicated
                                Reproductive system                                   Mild symptoms; Intervention not      Moderate symptoms; medical
Feminization of male            and breast disorders   Feminization acquired          indicated                            intervention indicated
                                                                                                                      Readily apparent obscuration of
                                                                                                                      anatomic architecture; obliteration
                                                                                      Mild swelling or obscuration of of skin folds; readily apparent
                                Reproductive system                                   anatomic architecture on close  deviation from normal anatomic
Edema: trunk/genital            and breast disorders   Genital edema                  inspection                      contour
                                Reproductive system                                                                   Symptomatic (e.g., pain or
Gynecomastia                    and breast disorders   Gynecomastia                   Asymptomatic breast enlargement psychosocial impact)




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      CTCAE v3.0 Term                     SOC              Proposed AE Term           Proposed Grade 1                      Proposed Grade 2

                                                                              Minimal bleeding identified on
Hemorrhage, GU Fallopian        Reproductive system                           clinical exam or imaging study;       Moderate bleeding; local
tube                            and breast disorders   Hematosalpinx          intervention not indicated            intervention indicated

                                                                              Mild changes in lactation, not        Changes in lactation, significantly
                                Reproductive system                           significantly affecting production or affecting breast production or
Breast function/lactation       and breast disorders   Lactation disorder     expression of breast milk             expression of breast milk
                                                                                                                    Moderate symptoms; medical
                                Reproductive system                                                                 intervention indicated (e.g.,
Orgasmic dysfunction            and breast disorders   Menorrhagia            Mild; iron supplements indicated      hormones)

                                                                                                                    Symptomatic; asymmetry of nipple
                                                                              Asymptomatic; asymmetry with          areolar complex with moderate
                                Reproductive system                           slight retraction and/or thickening   retraction and/or thickening of the
Breast nipple/areolar deformity and breast disorders   Nipple deformity       of the nipple aerolar complex         nipple aerolar complex
                                Reproductive system                           Sperm concentration >48               Sperm concentration 13 - 48
Infertility/sterility           and breast disorders   Oligospermia           million/mL or motility >68%           million/mL or motility 32 - 68%

                                                                              Minimal bleeding identified on
                                Reproductive system                           clinical exam or imaging study;       Moderate bleeding; local
Hemorrhage, GU Ovary            and breast disorders   Ovarian hemorrhage     intervention not indicated            intervention indicated
                                                                              Asymptomatic clinical or
                                Reproductive system                           diagnostic observations only;         Symptomatic and intervention not
Perforation, GU Ovary           and breast disorders   Ovarian rupture        intervention not indicated            indicated
                                Reproductive system                                                                 Moderate pain; limiting
Pain Ovulatory                  and breast disorders   Ovulation pain         Mild pain                             instrumental ADL

Muscle weakness,                                                              Asymptomatic; clinical or
generalized or specific area   Reproductive system     Pelvic floor muscle    diagnostic observations only;         Symptomatic, not interfering with
(not due to neuropathy) Pelvic and breast disorders    weakness               intervention not indicated            bladder, bowel, or vaginal function
                               Reproductive system                                                                  Moderate pain; limiting
Pain Pelvis                    and breast disorders    Pelvic pain            Mild pain                             instrumental ADL
                               Reproductive system                                                                  Moderate pain; limiting
Pain Penis                     and breast disorders    Penile pain            Mild pain                             instrumental ADL
                               Reproductive system                                                                  Moderate pain; limiting
Pain Perineum                  and breast disorders    Perineal pain          Mild pain                             instrumental ADL
Irregular menses (change       Reproductive system
from baseline)                 and breast disorders    Premature menopause                      -                                     -




                                                                              Asymptomatic; clinical or             Symptomatic; not interfering with
Stricture/stenosis (including   Reproductive system                           diagnostic observations only;         urination or sexual function;
anastomotic), GU Prostate       and breast disorders   Prostatic disorder     intervention not indicated            limiting instrumental ADL



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      CTCAE v3.0 Term                     SOC               Proposed AE Term                Proposed Grade 1                      Proposed Grade 2

                                                                                    Minimal bleeding identified on
                                Reproductive system                                 clinical exam or imaging study;       Moderate bleeding; local
Hemorrhage, GU Prostate         and breast disorders   Prostatic hemorrhage         intervention not indicated            intervention indicated
                                                                                    Asymptomatic; clinical or
                                Reproductive system                                 diagnostic observations only;
Obstruction, GU Prostate        and breast disorders   Prostatic obstruction        intervention not indicated                             -
                                Reproductive system                                                                       Moderate pain; limiting
Pain Prostate                   and breast disorders   Prostatic pain               Mild pain                             instrumental ADL




                                                                                                                          Moderate; minimal, local or
                                                                                    Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Sexual/Reproductive Function Reproductive system       Reproductive system and      clinical or diagnostic observations   limiting age-appropriate
- Other (Specify, __)        and breast disorders      breast - Other, specify      only; intervention not indicated      instrumental ADL
                             Reproductive system                                                                          Moderate pain; limiting
Pain Scrotum                 and breast disorders      Scrotal pain                 Mild pain                             instrumental ADL

                                                                                 Minimal bleeding identified on
Hemorrhage, GU Spermatic        Reproductive system                              clinical exam or imaging study;          Moderate bleeding; local
cord                            and breast disorders   Spermatic cord hemorrhage intervention not indicated               intervention indicated
                                                                                  Asymptomatic; clinical or
Obstruction, GU Spermatic       Reproductive system                               diagnostic observations only;
cord                            and breast disorders   Spermatic cord obstruction intervention not indicated                                -

                                                                                                                          Symptomatic but not interfering
                                                                                    Asymptomatic; clinical or             with urination or sexual activities;
Stricture/stenosis (including   Reproductive system                                 diagnostic observations only;         intervention not indicated; limiting
anastomotic), GU Testes         and breast disorders   Testicular disorder          intervention not indicated            instrumental ADL

                                                                                    Minimal bleeding identified on
                                Reproductive system                                 clinical exam or imaging study;       Moderate bleeding; local
Hemorrhage, GU Testes           and breast disorders   Testicular hemorrhage        intervention not indicated            intervention indicated
                                Reproductive system                                                                       Moderate pain; limiting
Pain Testicle                   and breast disorders   Testicular pain              Mild pain                             instrumental ADL
                                                                                    Asymptomatic clinical or
                                Reproductive system                                 diagnostic observations only;         Symptomatic and intervention not
Fistula, GU Uterus              and breast disorders   Uterine fistula              intervention not indicated            indicated

                                                                                    Minimal bleeding identified on
                                Reproductive system                                 clinical exam or imaging study;       Moderate bleeding; local
Hemorrhage, GU Uterus           and breast disorders   Uterine hemorrhage           intervention not indicated            intervention indicated




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      CTCAE v3.0 Term                        SOC              Proposed AE Term              Proposed Grade 1                      Proposed Grade 2
                                                                                    Asymptomatic; clinical or
                                   Reproductive system                              diagnostic observations only;
Obstruction, GU Uterus             and breast disorders   Uterine obstruction       intervention not indicated                            -
                                   Reproductive system                                                                   Moderate pain; limiting
Pain Uterus                        and breast disorders   Uterine pain              Mild pain                            instrumental ADL
                                                                                                                         Moderate to heavy vaginal
Vaginal discharge (non-            Reproductive system                              Mild vaginal discharge (greater      discharge; requiring use of
infectious)                        and breast disorders   Vaginal discharge         than normal for patient)             perineal pad or tampon

                                                                                                                         Moderate vaginal dryness
                                   Reproductive system                              Mild vaginal dryness not interfering interfering with sexual function or
Vaginal dryness                    and breast disorders   Vaginal dryness           with sexual function                 causing frequent discomfort
                                                                                    Asymptomatic clinical or
                                   Reproductive system                              diagnostic observations only;        Symptomatic and intervention not
Fistula, GU Vagina                 and breast disorders   Vaginal fistula           intervention not indicated           indicated

                                                                                    Minimal bleeding identified on
                                   Reproductive system                              clinical exam or imaging study;      Moderate bleeding; local
Hemorrhage, GU Vagina              and breast disorders   Vaginal hemorrhage        intervention not indicated           intervention indicated

                                                                                                                       Moderate discomfort or pain,
                                   Reproductive system                              Mild discomfort or pain, edema, or edema, or redness; limiting
Vaginitis (not due to infection)   and breast disorders   Vaginal inflammation      redness                            instrumental ADL



                                   Reproductive system                                                                   Asymptomatic; partial obstruction
Obstruction, GU Vagina             and breast disorders   Vaginal obstruction                         -                  of the vagina
                                   Reproductive system                                                                   Moderate pain; limiting
Pain Vagina                        and breast disorders   Vaginal pain              Mild pain                            instrumental ADL
                                                                                    Asymptomatic clinical or
                                   Reproductive system                              diagnostic observations only;        Symptomatic and intervention not
Perforation, GU Vagina             and breast disorders   Vaginal perforation       intervention not indicated           indicated

                                                                                                                         Vaginal narrowing and/or
                                   Reproductive system                              Asymptomatic; mild vaginal           shortening not interfering with
Vaginal stenosis/length            and breast disorders   Vaginal stricture         shortening or narrowing              physical examination
                                                                                                                         Moderate discomfort or pain
                                                                                    Mild discomfort or pain associated   associated with vaginal
                                                                                    with vaginal spasm/ tightening; no   spasm/tightening; disruption in
                                   Reproductive system                              impact upon sexual function or       sexual function and physical
Orgasmic dysfunction               and breast disorders   Vaginismus                physical examination                 examination

                                                                                    Minimal bleeding identified on
                            Reproductive system                                     clinical exam or imaging study;      Moderate bleeding; local
Hemorrhage, GU Vas deferens and breast disorders          Vas deferens hemorrhage   intervention not indicated           intervention indicated



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      CTCAE v3.0 Term                    SOC                  Proposed AE Term                Proposed Grade 1                  Proposed Grade 2
                                                                                      Asymptomatic; clinical or
                             Reproductive system                                      diagnostic observations only;
Obstruction, GU Vas deferens and breast disorders        Vas deferens obstruction     intervention not indicated                         -



Adult Respiratory Distress     Respiratory, thoracic and Adult respiratory distress
Syndrome (ARDS)                mediastinal disorders     syndrome                                      -                                 -
Allergic rhinitis (including
sneezing, nasal stuffiness,    Respiratory, thoracic and                              Mild symptoms; intervention not   Moderate symptoms; medical
postnasal drip)                mediastinal disorders     Allergic rhinitis            indicated                         intervention indicated



                               Respiratory, thoracic and
Apnea                          mediastinal disorders     Apnea                                         -                                 -

                                                                                                                        Altered eating habits; coughing or
                                                                                      Asymptomatic; clinical or         choking episodes after eating or
                               Respiratory, thoracic and                              diagnostic observations only;     swallowing; medical intervention
Aspiration                     mediastinal disorders     Aspiration                   intervention not indicated        indicated (e.g., suction or oxygen)
                                                                                                                        Symptomatic (e.g., dyspnea,
                                                                                                                        cough), medical intervention
                                                                                      Asymptomatic; clinical or         indicated (e.g., bronchoscopic
                               Respiratory, thoracic and                              diagnostic observations only;     suctioning, chest physiotherapy,
Atelectasis                    mediastinal disorders     Atelectasis                  intervention not indicated        suctioning)




                                                                                      Asymptomatic; clinical or
Fistula, pulmonary/upper       Respiratory, thoracic and                              diagnostic observations only;     Symptomatic; tube thoracostomy
respiratory Bronchus           mediastinal disorders     Bronchial fistula            intervention not indicated        or medical management indicated



Hemorrhage,
pulmonary/upper respiratory    Respiratory, thoracic and                              Mild symptoms; intervention not   Moderate symptoms; medical
Bronchus                       mediastinal disorders     Bronchial hemorrhage         indicated                         intervention indicated


                                                                                                                        Symptomatic (e.g., mild
                                                                                                                        wheezing), endoscopic evaluation
                                                                                                                        appropriate, radiographic evidence
                                                                                                                        of atelectasis/lobar collapse
                                                                                      Asymptomatic; clinical or         present, medical management
Obstruction/stenosis of airway Respiratory, thoracic and                              diagnostic observations only;     indicated (e.g., steroids,
Bronchus                       mediastinal disorders     Bronchial obstruction        intervention not indicated        bronchodilators)




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       CTCAE v3.0 Term                       SOC                 Proposed AE Term           Proposed Grade 1                   Proposed Grade 2
                                                                                                                       Symptomatic (e.g., rhonchi or
                                                                                                                       wheezing but without respiratory
                                                                                    Asymptomatic; clinical or          distress; medical intervention
Obstruction/stenosis of airway Respiratory, thoracic and                            diagnostic observations only;      indicated (e.g., steroids,
Bronchus                       mediastinal disorders     Bronchial stricture        intervention not indicated         bronchodilators)

Hemorrhage,
pulmonary/upper respiratory        Respiratory, thoracic and Bronchopulmonary       Mild symptoms; intervention not    Moderate symptoms; medical
Bronchopulmonary NOS               mediastinal disorders     hemorrhage             indicated                          intervention indicated



                                   Respiratory, thoracic and                        Mild symptoms; intervention not    Symptomatic; medical intervention
Bronchospasm, wheezing             mediastinal disorders     Bronchospasm           indicated                          indicated

                                                                                    Asymptomatic; clinical or
                                   Respiratory, thoracic and                        diagnostic observations only;      Symptomatic; thoracentesis or
Chylothorax                        mediastinal disorders     Chylothorax            intervention not indicated         tube drainage indicated
                                                                                                                       Moderate symptoms, medical
                                   Respiratory, thoracic and                        Mild symptoms; non-prescription    intervention indicated; limiting
Cough                              mediastinal disorders     Cough                  intervention indicated             instrumental ADL




                                   Respiratory, thoracic and
Laryngeal nerve dysfunction        mediastinal disorders     Dysesthesia pharynx                     -                                   -
                                                                                                                       Shortness of breath on exertion
                                                                                    Shortness of breath on exertion,   but unable to walk 1 flight of stairs
                              Respiratory, thoracic and                             but can walk 1 flight of stairs    or 1 city block (0.1km) without
Dyspnea (shortness of breath) mediastinal disorders     Dyspnea                     without stopping                   stopping
                                                                                                                       Moderate symptoms; medical
Hemorrhage,                                                                                                            intervention indicated (e.g., nasal
pulmonary/upper respiratory        Respiratory, thoracic and                        Mild symptoms; intervention not    packing, cauterization; topical
Nose                               mediastinal disorders     Epistaxis              indicated                          vasoconstrictors)
                                                                                                                       Moderate symptoms, medical
                               Respiratory, thoracic and                            Mild symptoms; intervention not    intervention indicated; limiting
Hiccoughs (hiccups, singultus) mediastinal disorders     Hiccups                    indicated                          instrumental ADL
                                                                                                                       Moderate or persistent voice
                                                                                                                       changes, may require occasional
Voice changes/dysarthria                                                            Mild or intermittent hoarseraspy   repetition but understandable on
(e.g., hoarseness, loss or         Respiratory, thoracic and                        voice or voice change; fully       telephone; medical intervention
alteration in voice, laryngitis)   mediastinal disorders     Hoarseness             understandable; self-resolves      indicated




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      CTCAE v3.0 Term                   SOC                 Proposed AE Term             Proposed Grade 1                       Proposed Grade 2


                                                                                                                        Decreased O(2) saturation with
                                                                                                                        exercise (e.g., pulse oximeter
                                                                                                                        <88%); intermittent supplemental
                              Respiratory, thoracic and                          Desaturation at night corrected by     oxygen; desaturation at night not
Hypoxia                       mediastinal disorders     Hypoxia                  CPAP                                   corrected by CPAP
                                                                                                                        Symptomatic; medical
                                                                                 Asymptomatic; clinical or              interventionn indicated (e.g.,
                              Respiratory, thoracic and                          diagnostic observations only;          dexamethasone, epinephrine,
Edema, larynx                 mediastinal disorders     Laryngeal edema          intervention not indicated             antihistamines)




                                                                                 Asymptomatic; clinical or
Fistula, pulmonary/upper      Respiratory, thoracic and                          diagnostic observations only;          Symptomatic; tube thoracostomy
respiratory Larynx            mediastinal disorders     Laryngeal fistula        intervention not indicated             or medical management indicated

Hemorrhage,
pulmonary/upper respiratory   Respiratory, thoracic and                          Mild cough or trace hemoptysis;        Moderate symptoms; medical
Larynx                        mediastinal disorders     Laryngeal hemorrhage     laryngoscopic findings.                intervention indicated
Mucositis/stomatitis
(functional/symptomatic)      Respiratory, thoracic and                                                                 Moderate sore throat; analgesics
Larynx                        mediastinal disorders     Laryngeal inflammation   Mild sore throat; raspy voice          indicated

Mucositis/stomatitis
(functional/symptomatic)      Respiratory, thoracic and                          Endoscopic findings only; mild         Moderate discomfort; altered oral
Larynx                        mediastinal disorders     Laryngeal mucositis      discomfort with normal intake          intake
                                                                                                                        Symptomatic (e.g., noisy airway
                                                                                                                        breathing), but causing no
                                                                                 Asymptomatic; clinical or              respiratory distress; medical
Obstruction/stenosis of airway Respiratory, thoracic and                         diagnostic observations only;          management indicated (e.g.,
Larynx                         mediastinal disorders     Laryngeal obstruction   intervention not indicated             steroids)
                                                                                                                        Symptomatic (e.g., noisy airway
                                                                                                                        breathing), but causing no
                                                                                 Asymptomatic; clinical or              respiratory distress; medical
Obstruction/stenosis of airway Respiratory, thoracic and                         diagnostic observations only;          management indicated (e.g.,
Larynx                         mediastinal disorders     Laryngeal stenosis      intervention not indicated             steroids)
                                                                                                                        Moderate symptoms; mild anxiety,
                                                                                 Mild symptoms; no dyspnea, no          but no dyspnea; short duration of
                              Respiratory, thoracic and Laryngopharyngeal        significant anxiety; no intervention   observation and or anxiolytic
Laryngeal nerve dysfunction   mediastinal disorders     dysesthesia              indicated                              indicated




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      CTCAE v3.0 Term                    SOC                 Proposed AE Term             Proposed Grade 1                    Proposed Grade 2




Obstruction/stenosis of airway Respiratory, thoracic and                                                              Transient episode; intervention not
Larynx                         mediastinal disorders     Laryngospasm                              -                  indicated



Hemorrhage,                                                                       Radiologic evidence only; minimal
pulmonary/upper respiratory    Respiratory, thoracic and                          symptoms; intervention not          Moderate symptoms; medical
Mediastinum                    mediastinal disorders     Mediastinal hemorrhage   indicated                           intervention indicated
Allergic rhinitis (including
sneezing, nasal stuffiness,    Respiratory, thoracic and                          Mild symptoms; intervention not     Moderate symptoms; medical
postnasal drip)                mediastinal disorders     Nasal congestion         indicated                           intervention indicated



                                                                                  Asymptomatic; clinical or           Symptomatic; tube thoracostomy
Fistula, pulmonary/upper       Respiratory, thoracic and                          diagnostic observations only;       or medical intervention indicated;
respiratory Pharynx            mediastinal disorders     Pharyngeal fistula       intervention not indicated          limiting instrumental ADL

Hemorrhage,
pulmonary/upper respiratory    Respiratory, thoracic and                          Mild symptoms; intervention not     Moderate symptoms; medical
Pharynx                        mediastinal disorders     Pharyngeal hemorrhage    indicated                           intervention indicated

Mucositis/stomatitis                                                              Endoscopic findings only; minimal
(functional/symptomatic)       Respiratory, thoracic and                          symptoms with normal oral intake; Pain requiring analgesics; altered
Pharynx                        mediastinal disorders     Pharyngeal mucositis     pain not requiring analgesics     oral intake; respiratory symptoms




                               Respiratory, thoracic and
Necrosis, GI Pharynx           mediastinal disorders     Pharyngeal necrosis                       -                                    -
                                                                                                                      Symptomatic (e.g., noisy airway
                                                                                                                      breathing), but causing no
                                                                                  Asymptomatic; clinical or           respiratory distress; medical
Obstruction/stenosis of airway Respiratory, thoracic and                          diagnostic observations only;       management indicated (e.g.,
Pharynx                        mediastinal disorders     Pharyngeal stenosis      intervention not indicated          steroids)

                               Respiratory, thoracic and                                                              Moderate pain; limiting
Pain Throat/pharynx/larynx     mediastinal disorders     Pharyngolaryngeal pain   Mild pain                           instrumental ADL




                                                                                  Asymptomatic; clinical or           Symptomatic; intervention
Pleural effusion (non-         Respiratory, thoracic and                          diagnostic observations only;       indicated (e.g., diuretics or up to 2
malignant)                     mediastinal disorders     Pleural effusion         intervention not indicated          therapeutic thoracenteses)



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      CTCAE v3.0 Term                    SOC                  Proposed AE Term           Proposed Grade 1                    Proposed Grade 2




                                                                                 Asymptomatic; clinical or           Symptomatic; tube thoracostomy
Fistula, pulmonary/upper       Respiratory, thoracic and                         diagnostic observations only;       or medical intervention indicated;
respiratory Pleura             mediastinal disorders     Pleural fistula         intervention not indicated          limiting instrumental ADL




Hemorrhage,                                                                                                          Symptomatic or associated with
pulmonary/upper respiratory    Respiratory, thoracic and                         Asymptomatic; mild hemorrhage       pneumothorax requiring chest tube
Pleura                         mediastinal disorders     Pleural hemorrhage      confirmed by thoracentesis          drainage

                               Respiratory, thoracic and                                                             Moderate pain; limiting
Pain Pleura                    mediastinal disorders     Pleuritic pain          Mild pain                           instrumental ADL

                                                                                 Asymptomatic; clinical or
Pneumonitis/pulmonary          Respiratory, thoracic and                         diagnostic observations only;       Symptomatic; medical intervention
infiltrates                    mediastinal disorders     Pneumonitis             intervention not indicated          indicated; limiting instrumental ADL

                                                                                 Asymptomatic; clinical or           Symptomatic; intervention
                               Respiratory, thoracic and                         diagnostic observations only;       indicated (e.g., hospitalization,
Pneumothorax                   mediastinal disorders     Pneumothorax            intervention not indicated          tube placement without sclerosis)
Allergic rhinitis (including
sneezing, nasal stuffiness,    Respiratory, thoracic and                         Mild symptoms; intervention not     Moderate symptoms; medical
postnasal drip)                mediastinal disorders     Postnasal drip          indicated                           intervention indicated

                               Respiratory, thoracic and                         Occasional/minimal production of    Frequent/moderate production of
Cough                          mediastinal disorders     Productive cough        sputum with cough                   sputum with cough



Pneumonitis/pulmonary          Respiratory, thoracic and                         Radiologic findings only; minimal   Moderate dyspnea on exertion;
infiltrates                    mediastinal disorders     Pulmonary edema         dyspnea on exertion                 medical intervention indicated




                                                                                                                     Moderate hypoxemia; evidence of
                                                                                 Mild hypoxemia; radiologic          pulmonary hypertension;
Pulmonary fibrosis             Respiratory, thoracic and                         pulmonary fibrosis < 25% of lung    radiographic pulmonary fibrosis 25-
(radiographic changes)         mediastinal disorders     Pulmonary fibrosis      volume                              50%

                                                                                 Asymptomatic; clinical or           Symptomatic; tube thoracostomy
Fistula, pulmonary/upper       Respiratory, thoracic and                         diagnostic observations only;       or medical management indicated;
respiratory Lung               mediastinal disorders     Pulmonary fistula       intervention not indicated          limiting instrumental ADL



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      CTCAE v3.0 Term                    SOC                  Proposed AE Term                 Proposed Grade 1                    Proposed Grade 2

Hemorrhage,                                                                                                                Moderate hemoptysis or
pulmonary/upper respiratory    Respiratory, thoracic and                               Mild hemoptysis, intervention not   respiratory symptoms; medical
Lung                           mediastinal disorders     Pulmonary hemorrhage          indicated                           intervention indicated
                                                                                                                           Moderate dyspnea, cough;
                                                                                                                           requiring evaluation by cardiac
                               Respiratory, thoracic and                               Minimal dyspnea; findings on        catheterization and medical
Pulmonary hypertension         mediastinal disorders     Pulmonary hypertension        physical exam or other evaluation   intervention



Pneumonitis/pulmonary          Respiratory, thoracic and
infiltrates                    mediastinal disorders     Respiratory failure                            -                                   -




                                                                                                                           Moderate; minimal, local or
                                                                                     Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Pulmonary/Upper Respiratory - Respiratory, thoracic and Respiratory, thoracic and    clinical or diagnostic observations   limiting age-appropriate
Other (Specify, __)           mediastinal disorders     mediastinal - Other, specify only; intervention not indicated      instrumental ADL

                                                                                       Fluid retention; less than 3 kg of
                               Respiratory, thoracic and                               weight gain; intervention with fluid Moderate signs or symptoms;
Retinoic acid syndrome""       mediastinal disorders     Retinoic acid syndrome        restriction and/or diuretics indicated steroids indicated
                                                                                                                           Symptomatic stenosis or
Nasal cavity/paranasal sinus   Respiratory, thoracic and                               Asymptomatic mucosal crusting;      edema/narrowing interfering with
reactions                      mediastinal disorders     Sinus disorder                blood-tinged secretions             airflow
                                                                                                                           Moderate apnea and oxygen
                                                                                                                           desaturation; excessive daytime
                               Respiratory, thoracic and                               Snoring and nocturnal sleep         sleepiness; medical evaluation
Apnea                          mediastinal disorders     Sleep apnea                   arousal without apneic periods      indicated
Allergic rhinitis (including
sneezing, nasal stuffiness,    Respiratory, thoracic and                               Mild symptoms; intervention not     Moderate symptoms; medical
postnasal drip)                mediastinal disorders     Sneezing                      indicated                           intervention indicated

                               Respiratory, thoracic and                                                                   Moderate pain; limiting
Pain Larynx                    mediastinal disorders     Sore throat                   Mild pain                           instrumental ADL



                               Respiratory, thoracic and                                                                   Moderate symptoms; medical
Edema, larynx                  mediastinal disorders     Stridor                                        -                  intervention indicated




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       CTCAE v3.0 Term                       SOC                 Proposed AE Term           Proposed Grade 1                    Proposed Grade 2




                                                                                    Asymptomatic; clinical or           Symptomatic; tube thoracostomy
Fistula, pulmonary/upper           Respiratory, thoracic and                        diagnostic observations only;       or medical intervention indicated;
respiratory Trachea                mediastinal disorders     Tracheal fistula       intervention not indicated          limiting instrumental ADL
Mucositis/stomatitis                                                                Endoscopic findings only; minimal
(functional/symptomatic)           Respiratory, thoracic and                        hemoptysis, pain, or respiratory    Moderate symptoms; medical
Trachea                            mediastinal disorders     Tracheal mucositis     symptoms                            intervention indicated
                                                                                                                        Symptomatic (e.g., noisy airway
                                                                                                                        breathing), but causing no
                                                                                    Asymptomatic; clinical or           respiratory distress; medical
Obstruction/stenosis of airway Respiratory, thoracic and                            diagnostic observations only;       management indicated (e.g.,
Trachea                        mediastinal disorders     Tracheal stenosis          intervention not indicated          steroids)




Voice changes/dysarthria                                                                                                Moderate or persistent change
(e.g., hoarseness, loss or         Respiratory, thoracic and                        Mild or intermittent change from    from normal voice; still
alteration in voice, laryngitis)   mediastinal disorders     Voice alteration       normal voice                        understandable



                                   Respiratory, thoracic and                        Detectable airway noise with        Moderate symptoms; medical
Bronchospasm, wheezing             mediastinal disorders     Wheezing               minimal symptoms                    intervention indicated


                                                                                                                        Hair loss 25 - 74%; loss may or
                                                                                                                        may not be noticeable to others
                                                                                                                        but is associated with increased
                                                                                    Hair loss 0 - 24%; loss is not      shedding and/or overall feeling of
                                                                                    noticeable to others; may have      less volume. May require hair
Hair loss/alopecia (scalp or       Skin and subcutaneous                            some mild increase in daily hair    style change to cover but does not
body)                              tissue disorders          Alopecia               shedding                            require hairpiece to camouflauge
                                                                                                                          Pronounced odor; psychosocial
                                   Skin and subcutaneous                            Mild odor; physician intervention     impact; patient seeks medical
Odor (patient odor)                tissue disorders          Body odor              not indicated but patient self-treats intervention




                                   Skin and subcutaneous                            Asymptomatic; blisters covering     Blisters covering 10-30% BSA;
Rash/desquamation                  tissue disorders          Bullous dermatitis     <10% BSA                            painful blisters

                                                                                                                        Covering 10-30% BSA; associated
                                   Skin and subcutaneous                            Covering <10% BSA; no               with erythema or pruritus limiting
Dry skin                           tissue disorders          Dry skin               associated erythema or pruritus     instrumental ADL



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      CTCAE v3.0 Term                     SOC                Proposed AE Term           Proposed Grade 1                       Proposed Grade 2
Rash: erythema multiforme
(e.g., Stevens-Johnson
syndrome, toxic epidermal        Skin and subcutaneous                          Target lesions covering <10%           Target lesions covering 10-30%;
necrolysis)                      tissue disorders        Erythema multiforme    BSA; no skin tenderness                skin tenderness



                                 Skin and subcutaneous                                                                 Erythema covering >90% BSA
Rash/desquamation                tissue disorders        Erythroderma                             -                    without associated symptoms

                                 Skin and subcutaneous                                                                 Covering 10-30% BSA; associated
Atrophy, subcutaneous fat        tissue disorders        Fat atrophy            Covering <10% BSA                      with erythema or tenderness
                                                                                                                       Involving more than 1 site;
                                 Skin and subcutaneous                          Limited to one site (palms, soles,     physician-directed intervention
Sweating (diaphoresis)           tissue disorders        Hyperhidrosis          or axillae); self care interventions   sought



                                                                                Increase in length or thickness of     Increase in length or thickness of
                                                                                hairs that is noticeable to patient    hairs that is very noticeable and
                                                                                and others but that does not           requires trimming or removal of
                                                                                require an intervention other than     hairs in a given area or causes
Hair loss/alopecia (scalp or     Skin and subcutaneous                          bleaching or removal individual        symptoms related to the hair
body)                            tissue disorders        Hypertrichosis         hairs                                  growth

                                 Skin and subcutaneous                                                                 Symptomatic; limiting instrumental
Sweating (diaphoresis)           tissue disorders        Hypohidrosis                             -                    ADL

Cushingoid appearance (e.g.,
moon face, buffalo hump,                                                                                               Covering 10-30% BSA; associated
centripetal obesity, cutaneous   Skin and subcutaneous                          Asymptomatic; covering <10%            tenderness; limiting instrumental
striae)                          tissue disorders        Lipohypertrophy        BSA                                    ADL
                                                                                Asymptomatic; clinical or
                                 Skin and subcutaneous                          diagnostic observations only;
Nail changes                     tissue disorders        Nail discoloration     intervention not indicated                               -

                                                                                Asymptomatic separation of the         Symptomatic separation of the nail
                                 Skin and subcutaneous                          nail bed from the nail plate or nail   bed from the nail plate or nail loss;
Nail changes                     tissue disorders        Nail loss              loss                                   limiting instrumental ADL
                                                                                Asymptomatic; clinical or
                                 Skin and subcutaneous                          diagnostic observations only;
Nail changes                     tissue disorders        Nail ridging           intervention not indicated                               -

                                 Skin and subcutaneous                                                                 Moderate pain; limiting
Pain Skin                        tissue disorders        Pain of skin           Mild pain                              instrumental ADL




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      CTCAE v3.0 Term                    SOC                Proposed AE Term           Proposed Grade 1                    Proposed Grade 2
                                                                                                                  Skin changes (e.g., peeling,
                                                        Palmar-plantar         Minimal skin changes or dermatitis blisters, bleeding, edema, or
                                Skin and subcutaneous   erythrodysesthesia     (e.g., erythema, edema, or         hypekeratosis) with pain; limiting
Rash: hand-foot skin reaction   tissue disorders        syndrome               hyperkeratosis) without pain       instrumental ADL




                                Skin and subcutaneous
Eyelid dysfunction              tissue disorders        Periorbital edema      Soft or non-pitting                 Indurated or pitting edema




                                Skin and subcutaneous                          Painless erythema; erythema         Tender erythema; painless
Photosensitivity                tissue disorders        Photosensitivity       covering <10% BSA                   erythema covering 10-30% BSA
                                                                                                                   Intense or widespread;
                                                                                                                   intermittent; skin changes from
                                                                                                                   scratching (e.g. edema,
                                                                                                                   papulation, excoriations,
                                                                                                                   lichenification, oozing/crusts); oral
                                Skin and subcutaneous                          Mild or localized; topical          therapy indicated; itch limiting
Pruritus/itching                tissue disorders        Pruritus               intervention indicated              instrumental ADL
Petechiae/purpura
(hemorrhage/bleeding into       Skin and subcutaneous                          Combined area of lesions covering Combined area of lesions covering
skin or mucosa)                 tissue disorders        Purpura                <10% BSA                          10-30% BSA; bleeding with trauma

                                                                                                                   10-30% of BSA; associated with
                                                                                                                   symptoms of pruritus or pain;
                                Skin and subcutaneous                                                              associated with psychosocial
Rash: acne/acneiform            tissue disorders        Rash acneiform         Asymptomatic; <10% of BSA           impact; limiting instrumental ADL

                                                                                                                   Macules/papules with or without
                                Skin and subcutaneous                                                              symptoms (pruritus, burning,
Rash: acne/acneiform            tissue disorders        Rash maculo-papular                      -                 tightness) covering 10-30% BSA

                                Skin and subcutaneous                                                              Moderate pain; limiting
Pain Scalp                      tissue disorders        Scalp pain             Mild pain                           instrumental ADL




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      CTCAE v3.0 Term                    SOC                 Proposed AE Term                 Proposed Grade 1                      Proposed Grade 2




                                                                                                                            Moderate; minimal, local or
                                                                                      Asymptomatic or mild symptoms;        noninvasive intervention indicated;
Dermatology/Skin - Other        Skin and subcutaneous    Skin and subcutaneous -      clinical or diagnostic observations   limiting age-appropriate
(Specify, __)                   tissue disorders         Other, specify               only; intervention not indicated      instrumental ADL

                                                                                      Covering <10% BSA; associated
                                Skin and subcutaneous                                 with telangiectasias, changes in      Covering 10-30% BSA; associated
Atrophy, skin                   tissue disorders         Skin atrophy                 skin color                            with striae or adnexal structures

                                Skin and subcutaneous                                 Covering <10% BSA; no                 Covering >10% BSA; associated
Hyperpigmentation               tissue disorders         Skin hyperpigmentation       psychosocial impact                   psychosocial impact
                                                                                                                            Hypopigmentation or
                                                                                      Hypopigmentation or                   depigmentation covering >10%
                                Skin and subcutaneous                                 depigmentation covering <10%          BSA; associated psychosocial
Hypopigmentation                tissue disorders         Skin hypopigmentation        BSA; no psychosocial impact           impact



                                                                                      Mild induration, able to move skin Moderate induration, only able to
Induration/fibrosis (skin and   Skin and subcutaneous                                 parallel to plane (sliding) and     slide skin, unable to pinch skin;
subcutaneous tissue)            tissue disorders         Skin induration              perpendicular to skin (pinching up) limiting instrumental ADL



                                                                                      Combined area of ulcers <1cm;
                                                                                      nonblanchable erythema of intact      Combined area of ulcers 1-2cm;
                                Skin and subcutaneous                                 skin with associated warmth or        partial thickness skin loss
Ulceration                      tissue disorders         Skin ulceration              edema                                 involving skin or subcutaneous fat.

Rash: erythema multiforme
(e.g., Stevens-Johnson
syndrome, toxic epidermal       Skin and subcutaneous
necrolysis)                     tissue disorders         Stevens-Johnson syndrome                       -                                    -

                                Skin and subcutaneous                                 Telangiectasias covering <10%         Telangiectasias covering >10%
Telangiectasia                  tissue disorders         Telangiectasia               BSA                                   BSA
Rash: erythema multiforme
(e.g., Stevens-Johnson
syndrome, toxic epidermal       Skin and subcutaneous
necrolysis)                     tissue disorders         Toxic epidermal necrolysis                     -                                    -

                                 Skin and subcutaneous                                <10% BSA; topical intervention        10 - 30% BSA; oral intervention
Urticaria (hives, welts, wheals) tissue disorders        Urticaria                    indicated                             indicated




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       CTCAE v3.0 Term                 SOC              Proposed AE Term                Proposed Grade 1                      Proposed Grade 2
Irregular menses (change                                                          Menopause occurring at age 46 -       Menopause occurring at age 40 -
from baseline)               Social circumstances   Menopause                     53                                    45




                                                                                                                        Moderate; minimal, local or
                                                                                  Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                                                    Social circumstances -        clinical or diagnostic observations   limiting age-appropriate
                             Social circumstances   other, specify                only; intervention not indicated      instrumental ADL




                                                                                                                        Moderate; minimal, local or
                                                                                  Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                             Surgical and medical   Surgical and medical          clinical or diagnostic observations   limiting age-appropriate
                             procedures             procedures - other, specify   only; intervention not indicated      instrumental ADL

                                                                                                                        Symptomatic; medical intervention
Acute vascular leak syndrome Vascular disorders     Capillary leak syndrome                         -                   indicated
                                                                                  Asymptomatic; clinical or             Moderate symptoms; medical
                                                                                  diagnostic observations only;         intervention indicated; limiting
Flushing                     Vascular disorders     Flushing                      intervention not indicated            instrumental ADL

                                                                                  Mild symptoms; intervention not       Minimally invasive evacuation or
Hematoma                     Vascular disorders     Hematoma                      indicated                             aspiration indicated
                                                                                  Mild symptoms; intervention not       Moderate symptoms; limiting
Hot flashes/flushes          Vascular disorders     Hot flashes                   indicated                             instrumental ADL
                                                                                                                     Stage 1 hypertension, Systolic BP
                                                                                                                     140 - 159 or diastolic BP 90 -99
                                                                                  Prehypertension, Systolic BP 120 - mm Hg, medical intervention may
Hypertension                 Vascular disorders     Hypertension                  139 or diastolic BP 80 - 89 mm Hg be indicated



                                                                                  Asymptomatic, intervention not        Non-urgent medical intervention
Hypotension                  Vascular disorders     Hypotension                   indicated                             indicated

                                                                                                                        Symptomatic; medical intervention
Chyle or lymph leakage       Vascular disorders     Lymph leakage                                                       indicated

Dermal change lymphedema,                                                         Trace thickening or faint             Marked discoloration; leathery skin
phlebolymphedema             Vascular disorders     Lymphedema                    discoloration                         texture; papillary formation
                                                                                  Asymptomatic; clinical or
                                                                                  diagnostic observations only;         Symptomatic; medical intervention
Lymphocele                   Vascular disorders     Lymphocele                    intervention not indicated            indicated




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      CTCAE v3.0 Term                        SOC            Proposed AE Term                  Proposed Grade 1                        Proposed Grade 2

                                                                                                                            Brief (<24 hrs) episode of
                                                                                                                            ischemia managed non-surgically
Peripheral arterial ischemia       Vascular disorders   Peripheral ischemia                             -                   and without permanent deficit
Phlebitis (including superficial
thrombosis)                        Vascular disorders   Phlebitis                                       -                   Present
Phlebitis (including superficial                        Superficial
thrombosis)                        Vascular disorders   thrombophlebitis                                -                   Present



                                                                                                                          Symptomatic; medical intervention
                                                        Superior vena caval           Asymptomatic; incidental finding of indicated (e.g., anticoagulation,
Cardiac ischemia/infarction        Vascular disorders   syndrome                      SVC thrombosis                      chemotherapy)




                                                                                                                         Venous thrombosis (e.g.deep vein
Thrombosis/thrombus/embolis                                                           Venous thrombosis (e.g.superficial thrombosis), medical intervention
m                           Vascular disorders          Thromboembolic event          thrombosis),                       indicated




                                                                                                                            Moderate; minimal, local or
                                                                                      Asymptomatic or mild symptoms;        noninvasive intervention indicated;
                                                        Vascular disorders - other,   clinical or diagnostic observations   limiting age-appropriate
                                   Vascular disorders   specify                       only; intervention not indicated      instrumental ADL



                                                                                      Asymptomatic, intervention not        Symptomatic; medical intervention
Vasculitis                         Vascular disorders   Vasculitis                    indicated                             indicated

                                                                                                                            Brief (<24 hrs) episode of
Visceral arterial ischemia (non-                                                                                            ischemia managed medically and
myocardial)                      Vascular disorders     Visceral arterial ischemia                      -                   without permanent deficit




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          Proposed Grade 3                    Proposed Grade 4           Proposed Grade 5



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated             Death
Severely hypocellular or >50 -
<=75% reduction cellularity from
normal for age                          Life-threatening consequences         Death

                                      Life-threatening consequences;
Laboratory findings and bleeding      urgent intervention indicated           Death




                                      Life-threatening consequences;
Present                               urgent intervention indicated           Death



Transfusion or medical
intervention (e.g., steroids)         Life-threatening consequences;
indicated                             urgent intervention indicated           Death


                                      Laboratory findings and life-
                                      threatening consequences, (e.g.,
Laboratory findings with clinical     CNS bleeding or
consequences (e.g., renal             thrombosis/embolism or renal
insufficiency, petechiae)             failure)                                Death

                                      Laboratory findings and clinical
                                      manifestations of leucostasis;
>100,000/mm(3)                        intervention indicated                    -
<2000 - 1000/mm(3) <2.0 - 1.0 x
10e9 /L                               <1000/mm(3) <1.0 x 10e9 /L              Death

Severe pain; limiting self care ADL                    -                        -

> 20000/uL                                             -                        -
<500 - 200 mm(3) <0.5 - 0.2 x
10e9 /L                               <200/mm(3) <0.2 x 10e9 /L                 -




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        Proposed Grade 3                      Proposed Grade 4              Proposed Grade 5
<1000 - 500/mm(3) <1.0 - 0.5 x
10e9 /L                               <500/mm(3) <0.5 x 10e9 /L                  Death



                                      Life-threatening consequences;
                 -                    urgent intervention indicated              Death
<50,000 - 25,000/mm(3) <50.0 -
25.0 x 10e9 /L                        <25,000/mm(3) <25.0 x 10e9 /L              Death


                                      Laboratory findings and life-
                                      threatening consequences, (e.g.,
Laboratory findings with clinical     CNS hemorrhage/bleeding or
consequences (e.g., renal             thrombosis/embolism or renal
insufficiency, petechiae)             failure)                                   Death

Symptomatic, unstable angina          Symptomatic, unstable angina
and/or acute myocardial infarction,   and/or acute myocardial infarction,
cardiac enzymes abnormal,             cardiac enzymes abnormal,
hemodynamically stable                hemodynamically unstable                   Death



Symptomatic; severe regurgitation Life-threatening consequences;
or stenosis; symptoms controlled  urgent intervention indicated (e.g.,
with medical intervention         valve replacement, valvuloplasty)              Death

Severe, medically significant;        Life-threatening consequences;
medical intervention indicated        urgent intervention indicated              Death
Symptomatic and incompletely
controlled medically, or controlled
with device (e.g., pacemaker), or     Life-threatening consequences;
ablation                              urgent intervention indicated              Death
Symptomatic and incompletely
controlled medically, or controlled
with device (e.g., pacemaker), or     Life-threatening consequences;
ablation                              urgent intervention indicated              Death



Symptomatic and incompletely
controlled medically, or controlled   Life-threatening consequences;
with device (e.g., pacemaker)         urgent intervention indicated              Death




                  -                                    -                           -




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        Proposed Grade 3                      Proposed Grade 4               Proposed Grade 5

                                      Life-threatening consequences;
                  -                   urgent intervention indicated               Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated                 Death
Moderate to severe pain with
minimal activity                    Severe pain at rest                             -



Severe symptoms; intervention         Life-threatening consequences;
indicated                             urgent intervention indicated               Death
Symptomatic heart failure or other
cardiac symptoms, responsive to       Refractory heart failure or other
intervention                          poorly controlled cardiac symptoms          Death



                                      Life-threatening consequences;
Severe with symptoms at rest or       urgent intervention indicated (e.g.,
with minimal activity or exertion;    continuous intravenous therapy or
intervention indicated                mechanical hemodynamic support)             Death



                                      Life threatening consequences;
Severe with symptoms at rest or       urgent intervention indicated with
with minimal activity or exertion;    continuous intravenous therapy or
intervention indicated                mechanical hemodynamic support              Death



Symptomatic; severe regurgitation Life-threatening consequences;
or stenosis; symptoms controlled  urgent intervention indicated (e.g.,
with medical intervention         valve replacement, valvuloplasty)               Death



Symptomatic and incompletely
controlled medically, or controlled   Life-threatening consequences;
with device (e.g., pacemaker)         urgent intervention indicated               Death




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        Proposed Grade 3                      Proposed Grade 4             Proposed Grade 5



Symptomatic and incompletely
controlled medically, or controlled   Life-threatening consequences;
with device (e.g., pacemaker)         urgent intervention indicated             Death

Severe symptoms; cardiac              Symptomatic; cardiac enzymes
enzymes abnormal;                     abnormal; hemodynamically
hemodynamically stable; ECG           unstable; ECG changes consistent
changes consistent with infarction    with infarction                           Death



                                      Life threatening consequences;
Severe with symptoms at rest or       urgent intervention indicated with
with minimal activity or exertion;    continuous intravenous therapy or
intervention indicated                mechanical hemodynamic support            Death

                  -                                    -                          -

                                      Life threatening consequences;
                                      incompletely controlled medically;
Intraveous medication indicated       cardioversion indicated                   Death

Effusion with physiologic             Life-threatening consequences;
consequences                          urgent intervention indicated             Death

                                      Life-threatening consequences;
                  -                   urgent intervention indicated             Death

Pericarditis with physiologic
consequences (e.g., pericardial       Life-threatening consequences;
constriction)                         urgent intervention indicated             Death



Symptomatic; severe regurgitation Life-threatening consequences;
or stenosis; symptoms controlled  urgent intervention indicated (e.g.,
with medical intervention         valve replacement, valvuloplasty)             Death
Symptomatic heart failure or other
cardiac symptoms, responsive to       Refractory heart failure or other
intervention                          poorly controlled cardiac symptoms        Death

                                 Symptomatic cor pulmonale poorly
Severe symptoms, associated with controlled; intervention such as
hypoxemia, right heart failure;  ventricular assist device, or heart
oxygen required                  transplant indicated                           Death



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        Proposed Grade 3                    Proposed Grade 4             Proposed Grade 5



Severe, medically significant;       Life-threatening consequences;
medical intervention indicated       urgent intervention indicated            Death

Severe, medically significant;       Life-threatening consequences;
medical intervention indicated       urgent intervention indicated            Death



Medical intervention indicated                       -                          -



                                     Life-threatening consequences;
Medical intervention indicated       urgent intervention indicated            Death



Symptomatic; severe regurgitation Life-threatening consequences;
or stenosis; symptoms controlled  urgent intervention indicated (e.g.,
with medical intervention         valve replacement, valvuloplasty)           Death

                                     Life-threatening consequences;
                                     hemodynamic compromise; urgent
Medical intervention indicated       intervention indicated                   Death

                                     Life-threatening consequences;
                                     hemodynamic compromise; urgent
                 -                   intervention indicated                   Death

                                     Life-threatening consequences;
                                     hemodynamic compromise; urgent
Medical intervention indicated       intervention indicated                   Death

Symptomatic and incompletely
controlled medically or controlled   Life-threatening consequences;
with procedure                       urgent intervention indicated            Death

Major anomalies, not life-           Life-threatening consequences;
threatening                          urgent intervention indicated            Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated             Death



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        Proposed Grade 3                      Proposed Grade 4               Proposed Grade 5



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated                 Death

Severe pain; limiting self care ADL                     -                           -




                                      Necrosis of soft tissue or bone;
External otitis with mastoiditis;     urgent operative intervention
stenosis or osteomyelitis             indicated                                   Death

Severe pain; limiting self care ADL                     -                           -




Adult only: Enrolled in Monitoring
Program(1, 2, 4, 6 and 8 kHz
)audiogram: Threshold shift of
>25 dB averaged at 3 contiguous
test frequencies in at least one
ear; need therapeutic intervention.
Adult: Not enrolled in Monitoring
Program: Hearing loss requiring
hearing aid or intervention (i.e.,
interfering with functional ADLs).
Pediatric (on a 1, 2, 4, 6 and 8kHz   Adult only: Profound bilateral
augiogram): Hearing loss sufficient   hearing loss (>80 dB at 2 kHz and
to indicate therapeutic               above); nonservicable hearing;
intervention, including hearing       Pediatric: Audiologic indication for
aids; > 20 dB at 4 kHz and above      cochlear implant and requiring
in one ear ; requiring additional     additional speech-language
speech-language related services      related services                              -

Mastoiditis; necrosis of canal soft   Life-threatening consequences;
tissue or bone                        urgent intervention indicated               Death
Severe symptoms; limiting self
care ADL                                                -                           -
Severe symptoms; limiting self
care ADL                                                -                           -



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       Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5
Severe symptoms; limiting self
care ADL                                              -                       -

Severe symptoms; hospitalization      Life-threatening consequences;
indicated                             urgent intervention indicated         Death

Severe symptoms; medical
intervention or hospitalization
indicated                                             -                       -

No sexual development by age 14
yrs for girls, age 16 yrs for boys;
hormone replacement indicated                         -                       -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated           Death

                  -                                   -                       -

                  -                                   -                       -



Severe symptoms; limiting self      Life-threatening consequences;
care ADL; hospitalization indicated urgent intervention indicated           Death
Severe symptoms; medical
intervention or hospitalization       Life-threatening consequences;
indicated                             urgent intervention indicated         Death

Severe symptoms; limiting self
care ADL; hospitalization indicated Life-threatening myxedema coma          Death




                  -                                   -                       -

                                      Life-threatening consequences;
                  -                   urgent intervention indicated         Death

                  -                                   -                       -

Limiting self care ADL                                -                       -



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        Proposed Grade 3                   Proposed Grade 4            Proposed Grade 5


Symptomatic with marked
decrease in visual acuity (worse
than 20/40 but better than 20/200);
operative intervention indicated
(e.g., cataract surgery)            Blindness (20/200 or worse)               -



Limiting self care ADL; operative
intervention indicated                               -                        -

Limiting self care ADL; operative
intervention indicated; declining
vision (worse than 20/40 but better Perforation or Blindness (20/200
than 20/200)                        or worse)                                 -
Decrease in visual acuity ; limiting
self care ADL; multiple
interventions                                        -                        -



Limiting self care ADL                               -                        -



Limiting self care ADL; surgical
intervention indicated; disabling                    -                        -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated           Death

Severe pain; limiting self care ADL                  -                        -



Limiting self care ADL; operative
intervention indicated                               -                        -

Limiting self care ADL                               -                        -

Limiting self care ADL                               -                        -




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        Proposed Grade 3                        Proposed Grade 4              Proposed Grade 5


EIOP causing marked visual field
deficits (e.g., involving both
superior and inferior visual fields);
operative intervention indicated;
limiting basic care ADL;                Blindness (20/200 or worse)                  -



Decline in vision (worse than           Perforation or blindness (20/200 or
20/40 but better than 20/200)           worse) in the involved eye                   -
Limiting self care ADL                                     -                         -
Limiting vision in the affected eye
(worse than 20/40 but better than       Severely depressed vision
20/200)                                 (>20/200) in the affected eye                -

Marked visual field defect (worse
than 20/40 but better than 20/200)      Blindness (20/200 or worse)                  -
Limiting self care ADL                                  -                            -

Rhegmatogenous or exudative
detachment; operative intervention
indicated; decline in vision (worse
than 20/40 but better than 20/200) blindness (20/200 or worse)                       -
Vitroretinal surgical repair or
hospitalization indicated           Blindness (20/200 or worse)                      -
Symptomatic with marked
decrease in visual acuity (worse
than 20/40); disabling; limiting self
care ADL                                Blindness (20/200 or worse)                  -

Symptomatic, limiting self care
ADL; marked decrease in visual
acuity (worse than 20/40);
operative intervention indicated;       Blindness (20/200 or worse)                  -

                                        Blindness (20/200 or worse);
Posterior or pan-uveitis                enucleation indicated                        -



Limiting self care ADL; vitrectomy
indicated                               Blindness (20/200 or worse)                  -

                                                         -                           -




83                                                                                               1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5

Severe discomfort; limiting self
care ADL                                               -                       -

Severe pain; limiting self care ADL                    -                       -


Severely altered GI function (e.g.,
altered dietary habits, diarrhea, or
GI fluid loss); hospitalization
indicated; TPN indicated; elective     Life-threatening consequences;
operative intervention indicated       urgent intervention indicated         Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death

Severe symptoms; limiting self         Life-threatening consequences;
care ADL                               urgent intervention indicated         Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                             Death

Severe pain; limiting self care ADL                    -                       -



Symptomatic and severely altered
GI function; tube feedings; non-     Life-threatening consequences;
emergent operative intervention      urgent operative intervention
indicated; hospitalization indicated indicated                               Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death
                                       Life-threatening consequences;
Severe symptoms; intervention          urgent operative intervention
indicated                              indicated                             Death



                   -                                   -                       -
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death




84                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5

Severe symptoms; limiting self
care ADL; intervention indicated                       -                       -
Severe abdominal pain, fever;
change in bowel habits, medical
intervention indicated; peritoneal     Life-threatening consequences;
signs                                  urgent intervention indicated         Death


Severely altered GI function (e.g.,
altered dietary habits, diarrhea, or
GI fluid loss); hospitalization
indicated; TPN indicated; elective     Life-threatening consequences;
operative intervention indicated       urgent intervention indicated         Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Persistent and debilitating
symptoms; hospitalization              Life-threatening consequences;
indicated; elective operative          urgent operative intervention
intervention indicated                 indicated                             Death

Severe symptoms; elective              Life-threatening consequences;
operative intervention indicated       urgent intervention indicated         Death
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death

Obstipation with manual
evacuation indicated; limiting self    Life-threatening consequences;
care ADL                               urgent intervention indicated         Death
Increase of >=7 stools per day
over baseline; incontinence;
hospitalization indicated; severe
increase in ostomy output
compared to baseline; limiting self    Life-threatening consequences;
care ADL                               urgent intervention indicated         Death




85                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5



Inability to adequately aliment
orally; IV fluids, tube feedings, or
TPN indicated; unstimulated saliva
<0.1 ml/min                                            -                       -


Severely altered GI function (e.g.,
altered dietary habits, diarrhea, or
GI fluid loss); hospitalization
indicated; TPN indicated; elective     Life-threatening consequences;
hospitalization indicated              urgent intervention indicated         Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Persistent and debilitating
symptoms; hospitalization              Life-threatening consequences;
indicated; elective operative          urgent operative intervention
intervention indicated                 indicated                             Death
                                       Life-threatening consequences;
Severe symptoms; elective              urgent operative intervention
operative intervention indicated       indicated                             Death
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death
Severe symptoms; intervention
indicated                                             -                        -


Severely altered eating/swallowing
(e.g., inadequate oral caloric or
fluid intake); tube feeding;
hospitalization indicated; TPN     Life-threatening consequences;
indicated                          urgent intervention indicated             Death

Severe or persistent abdominal         Life-threatening consequences;
pain, fever; ileus; peritoneal signs   urgent intervention indicated         Death

Severe or persistent abdominal         Life-threatening consequences;
pain, fever; ileus; peritoneal signs   urgent intervention indicated         Death



86                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5

Severe, medically significant;         Life-threatening consequences;
medical intervention indicated         urgent intervention indicated         Death
Severely altered GI function (e.g.,
bowel rest, altered dietary habits,
diarrhea, or GI fluid loss); tube
feeding; hospitalization indicated;    Life-threatening consequences;
TPN                                    urgent intervention indicated         Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Severe pain; interfering with oral
intake; tube feeding;                  Life-threatening consequences;
hospitalization indicated; TPN         urgent operative intervention
indicated                              indicated                             Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                             Death
Persistent and debilitating
symptoms; hospitalization
indicated; elective operative          Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death

Severe pain; limiting self care ADL                    -                       -
                                       Life-threatening consequences;
Severe symptoms; elective              urgent operative intervention
operative intervention indicated       indicated                             Death
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death




87                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5


Severely altered eating/swallowing
(e.g., inadequate oral caloric or
fluid intake); tube feeding;       Life-threatening consequences;
hospitalization indicated; TPN     urgent operative intervention
indicated                          indicated                                 Death
Severe symptoms; elective
operative intervention indicated                     -                         -

                   -                                   -                       -


Severely altered GI function (e.g.,
bowel rest, altered dietary habits,
diarrhea, or GI fluid loss); tube
feeding; hospitalization indicated;    Life-threatening consequences;
TPN indicated; elective operative      urgent operative intervention
intervention indicated                 indicated                             Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Severe pain; interfering with oral
intake; tube feeding;                  Life-threatening consequences;
hospitalization indicated; TPN         urgent operative intervention
indicated                              indicated                             Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                             Death
                                       Life-threatening consequences;
Severe symptoms; elective              urgent operative intervention
operative intervention indicated       indicated                             Death
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death




88                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5
Severely altered eating or gastric
function (e.g., inadequate oral
caloric or fluid intake);              Life-threatening consequences;
hospitalization indicated; TPN         urgent operative intervention
indicated                              indicated                             Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated            Death
Severely altered GI function (e.g.,
bowel rest, altered dietary habits,
diarrhea, or GI fluid loss); tube      Life-threatening consequences;
feeding; hospitalization indicated;    urgent operative intervention
TPN                                    indicated                             Death

Severe pain; limiting self care ADL                    -                       -

Severe pain; limiting self care ADL                    -                       -
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Severe symptoms; radiologic,
endoscopic or elective operative
intervention indicated                                 -                       -


Severely altered GI function (e.g.,
altered dietary habits, diarrhea, or
GI fluid loss); hospitalization
indicated; TPN indicated; elective     Life-threatening consequences;
operative intervention indicated       urgent intervention indicated         Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Persistent and debilitating
symptoms; hospitalization              Life-threatening consequences;
indicated; elective operative          urgent operative intervention
intervention indicated                 indicated                             Death
                                       Life-threatening consequences;
Severe symptoms; elective              urgent operative intervention
operative intervention indicated       indicated                             Death




89                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death

Severely altered GI function; TPN      Life-threatening consequences;
indicated                              urgent intervention indicated         Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                             Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death


Severely altered GI function (e.g.,
altered dietary habits, diarrhea, or
GI fluid loss); hospitalization
indicated; TPN indicated; elective     Life-threatening consequences;
operative intervention indicated       urgent intervention indicated         Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Persistent and debilitating
symptoms; hospitalization              Life-threatening consequences;
indicated; elective operative          urgent operative intervention
intervention indicated                 indicated                             Death
                                       Life-threatening consequences;
Severe symptoms; elective              urgent operative intervention
operative intervention indicated       indicated                             Death
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death



90                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5
Persistent symptoms; severe            Life-threatening consequences;
diarrhea; hospitalization indicated;   urgent operative intervention
TPN indicated                          indicated                             Death

Severe pain; limiting self care ADL                    -                       -
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death



Inability to aliment adequately;       Life-threatening consequences;
TPN indicated                          urgent intervention indicated         Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,
endoscopic, or operative               Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Inadequate oral caloric or fluid
intake; tube feeding;
hospitalization indicated; TPN
indicated                                              -                       -
Persistent and debilitating
symptoms; hospitalization              Life-threatening consequences;
indicated; elective operative          urgent operative intervention
intervention indicated                 indicated                             Death


Severely altered GI function (e.g.,
altered dietary habits, diarrhea, or
GI fluid loss); hospitalization
indicated; TPN indicated; elective     Life-threatening consequences;
operative intervention indicated       urgent intervention indicated         Death
Disabling pain; tube feedings or
TPN indicated                                          -                       -
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death

Severe pain; limiting self care ADL                    -                       -
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death




91                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5


Severely altered GI function (e.g.,
bowel rest, altered dietary habits,
diarrhea, or GI fluid loss); tube
feeding; hospitalization indicated;    Life-threatening consequences;
TPN indicated; elective operative      urgent operative intervention
intervention indicated                 indicated                             Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                             Death

Severe pain; nausea; vomiting;
medical intervention indicated         Life-threatening consequences;
(e.g., analgesia, nutritional support) urgent intervention indicated         Death
Spontaneous bleeding; severe
bone loss with or without tooth
loss; osteonecrosis of maxilla or
mandible                                               -                       -
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                             Death

Severe pain; limiting self care ADL                    -                       -



Severe symptoms; fecal urgency
or stool incontinence; limiting self   Life-threatening consequences;
care ADL                               urgent intervention indicated         Death


Severely altered GI function (e.g.,
bowel rest, altered dietary habits,
diarrhea, or GI fluid loss); tube
feeding; hospitalization indicated;
TPN indicated; elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death



92                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5
                                       Life-threatening consequences;
Severe symptoms; limiting self         urgent operative intervention
care ADL                               indicated                             Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                             Death
Persistent and debilitating
symptoms; hospitalization              Life-threatening consequences;
indicated; elective operative          urgent operative intervention
intervention indicated                 indicated                             Death

Severe pain; limiting self care ADL                    -                       -
                                       Life-threatening consequences;
Severe symptoms; elective              urgent operative intervention
operative intervention indicated       indicated                             Death
Severely altered GI function; tube
feeding; hospitalization indicated;    Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                Death
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death

Acute salivary gland necrosis;
severe secretion-induced
symptoms; limiting self care ADL;      Life-threatening consequences;
disabling                              urgent intervention indicated         Death


Severely altered GI function (e.g.,
altered dietary habits, diarrhea, or
GI fluid loss); tube feeding;          Life-threatening consequences;
hospitalization indicated; elective    urgent operative intervention
operative intervention indicated       indicated                             Death
Severe pain; interfering with oral
intake; tube feeding;
hospitalization indicated; TPN         Life-threatening consequences;
indicated                              urgent intervention indicated         Death




93                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

         Proposed Grade 3                       Proposed Grade 4          Proposed Grade 5
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,       Life-threatening consequences;
endoscopic, or operative                 urgent operative intervention
intervention indicated                   indicated                             Death
Persistent and debilitating
symptoms; hospitalization                Life-threatening consequences;
indicated; elective operative            urgent operative intervention
intervention indicated                   indicated                             Death
                                         Life-threatening consequences;
Severe symptoms; elective                urgent operative intervention
operative intervention indicated         indicated                             Death
Symptomatic and severely altered
GI function; tube feeding;
hospitalization indicated; non-          Life-threatening consequences;
emergent operative intervention          urgent operative intervention
indicated                                indicated                             Death

Debilitating symptoms; severely
altered GI function; TPN indicated; Life-threatening consequences;
elective operative or endoscopic    urgent operative intervention
intervention indicated              indicated                                  Death

Severe pain; limiting self care ADL                      -                       -

Severe pain; interferring with oral
intake (e.g., inadequate oral
caloric or fluid intake); IV fluids or   Life-threatening consequences;
tube feeding or TPN indicated            urgent intervention indicated         Death

Maldevelopment with impairment
not surgically correctable; disabling                    -                       -

                   -                                     -                       -




Full mouth extractions indicated                         -                       -

Severe pain; limiting self care ADL                      -                       -

Symptomatic (e.g, abdominal pain, Life-threatening consequences;
fever, change in bowel habits with urgent operative intervention
ileus); peritoneal signs           indicated                                   Death




94                                                                                           1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5
Transfusion, radiologic,
endoscopic, or elective operative      Life-threatening consequences;
intervention indicated                 urgent intervention indicated           Death
>=6 episodes (separated by 5
minutes) in 24 hrs; tube feeding;
hospitalization indicated; TPN         Life-threatening consequences;
indicated                              urgent intervention indicated           Death
Severe lack or loss of bodily
strength or energy; limiting self
care ADL; disabling                                    -                          -

Severe or prolonged, not
responsive to narcotics                                -                          -



                  -                                                            Death
                                                                          Death of liveborn
                                                                        infant within 30 days
                  -                                    -                    of live delivery




>30% inter-limb discrepancy in
volume; gross deviation from
normal anatomic contour; limiting
self care ADL                                          -                          -



Gross deviation from normal
anatomic contour; limiting self care
ADL                                                    -                          -

Severe swelling; limiting self care
ADL                                                    -                          -



Severe pain; limiting self care ADL                    -                          -

Fatigue not relieved by rest;
limiting self care ADL                                 -                          -




95                                                                                              1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                   Proposed Grade 4            Proposed Grade 5



>40.0 degrees C (>104.0 degrees     >40.0 degrees C (>104.0 degrees
F) for <=24 hrs                     F) for >24 hrs                          Death

Severe symptoms; limiting self
care ADL                                             -                        -

Severe change in gait (e.g, wide-
based, limping or hobbling );
assistive device indicated;
disabling; limiting self care ADL                    -                        -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated           Death


                                    <=28 degrees C 82.4 degrees F
                                    or life-threatening consequences
                                    (e.g., coma, hypotension,
32 - >28 degrees C 89.6 - >82.4     pulmonary edema, acidemia,
degrees F                           ventricular fibrillation)               Death


Prolonged (e.g., not rapidly
responsive to symptomatic
medication and/or brief interruption
of infusion); recurrence of
symptoms following initial
improvement; hospitalization
indicated for other clinical
sequelae (e.g., renal impairment,    Life-threatening consequences;
pulmonary infiltrates)               urgent intervention indicated          Death
Ulceration or necrosis; severe
tissue damage; operative            Life-threatening consequences;
intervention indicated              urgent intervention indicated           Death
Ulceration or necrosis; severe
tissue damage; operative            Life-threatening consequences;
intervention indicated              urgent intervention indicated           Death




96                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

         Proposed Grade 3                      Proposed Grade 4               Proposed Grade 5

Abnormal or excessive response
resulting in uncontrolled anger,
hostility, rage or other emotion;
inconsolable                                             -                           -

Severe localized edema; limiting
with self care ADL                                       -                           -



                   -                                     -                           -
Shock with azotemia and acid-          Vasopressor dependent and
base disturbances; significant         oliguric or anuric; ischemic colitis
coagulation abnormalities              and lactic acidosis                         Death
Generalized neck edema (e.g.,
difficulty in turning neck) limiting
self care ADL                                            -                           -



Severe pain; limiting self care ADL                      -                           -



Severe pain; limiting self care ADL                      -                           -




                   -                                     -                           -

Severe or complete occlusion,
disabling dysfunction of catheter;
medical intervention indicated                           -                           -



Severe symptoms; radiologic,           Life-threatening consequences;
endoscopic or elective operative       urgent operative intervention
intervention indicated                 indicated                                   Death
Symptomatic or severely altered
GI function (e.g., altered dietary
habits); TPN indicated;
endoscopic intervention indicated;     Life-threatening consequences;
elective operative intervention        urgent operative intervention
indicated                              indicated                                   Death




97                                                                                               1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4          Proposed Grade 5
Severe symptoms; radiologic,          Life-threatening consequences;
endoscopic or elective operative      urgent operative intervention
intervention indicated                indicated                             Death
Symptomatic or severely altered
GI function (e.g., altered dietary
habits); TPN indicated;
endoscopic intervention indicated;    Life-threatening consequences;
elective operative intervention       urgent operative intervention
indicated                             indicated                             Death

                                      Life-threatening consequences;
                                      urgent radiologic or operative
                 -                    intervention indicated                Death


Symptomatic and severly altered
GI function; IV fluids > 12 hrs, tube
feedings or TPN indicated; non-       Life-threatening consequences;
emergent operative intervention       urgent operative intervention
indicated.                            indicated                             Death

Severe pain; limiting self care ADL                   -                       -

                                      Life-threatening consequences;
                 -                    urgent intervention indicated         Death

                                      Life-threatening consequences;
Transfusion indicated                 urgent intervention indicated         Death

                                      Life-threatening consequences;
                                      urgent radiologic or operative
                 -                    intervention indicated                Death

Severe pain; limiting self care ADL                   -                       -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated           Death

>3.0 - 10.0 x ULN                     >10.0 x ULN                             -
                                      Life-threatening consequences;
Radiologic, endoscopic or elective    urgent operative intervention
operative intervention indicated      indicated                             Death



98                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4          Proposed Grade 5
Reversal/retrograde portal vein
flow; associated with varices         Life-threatening consequences;
and/or ascites                        urgent intervention indicated         Death

                                      Life-threatening consequences;
Medical intervention indicated        urgent intervention indicated         Death


Prolonged (e.g., not rapidly
responsive to symptomatic
medication and/or brief interruption
of infusion); recurrence of
symptoms following initial
improvement; hospitalization
indicated for other clinical
sequelae (e.g., renal impairment,    Life-threatening consequences;
pulmonary infiltrates)               urgent intervention indicated          Death


Symptomatic bronchospasm, with
or without urticaria; parenteral
intervention indicated; allergy-
related edema/angioedema;             Life-threatening consequences;
hypotension                           urgent intervention indicated         Death



Autoimmune reactions involving
major organ (e.g., colitis, anemia,   Life-threatening consequences;
myocarditis, kidney)                  urgent intervention indicated         Death


Prolonged (e.g., not rapidly
responsive to symptomatic
medication and/or brief interruption
of infusion); recurrence of
symptoms following initial
improvement; hospitalization
indicated for other clinical         Life-threatening consequences;
sequelae (e.g., renal impairment,    pressor or ventilatory support
pulmonary infiltrates)               indicated                              Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated           Death




99                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5
Severe arthralgia or arthritis;        Life-threatening consequences;
extensive rash; steroids or IV         pressor or ventilatory support
fluids indicated                       indicated                             Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

Severe symptoms; elective              Life-threatening consequences;
operative intervention indicated       urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

Severe infection; axillary adenitis;
IV antibacterial, antifungal, or       Life-threatening consequences;
antiviral intervention indicated       urgent intervention indicated         Death




100                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4            Proposed Grade 5

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death


IV antibiotic, antifungal, or antiviral
intervention indicated; severe
changes in mental status; self-
limited seizure activity; focal         Life-threatening consequences;
neurologic abnormalities                urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death




101                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4           Proposed Grade 5

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death
Systemic intervention or
hospitalization indicated               Blindness (20/200 or worse)            -

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death
Symptomatic liver dysfunction;
fibrosis by biopsy; compensated      Decompensated liver function
cirrhosis. reactivation of chronic   (e.g., ascites, coagulopathy,
hepatitis                            encephalopathy, coma)                   Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated            Death



102                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

         Proposed Grade 3                    Proposed Grade 4            Proposed Grade 5



IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or
operative intervention indicated;
profuse watery diarrhea with signs
of hypovolemia; bloody diarrhea;
temperature; IV hydration               Life-threatening consequences;
indicated; severe abdominal pain        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or
operative intervention indicated;       Life-threatening consequences;
focal neurologic deficit                urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death




Arthroscopic intervention indicated
(e.g., drainage) or arthrotomy      Life-threatening consequences;
(e.g., open surgical drainage)      urgent intervention indicated             Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or
operative intervention indicated                       -                        -

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated         Death




103                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

         Proposed Grade 3                        Proposed Grade 4          Proposed Grade 5

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or
operative intervention indicated                          -                       -

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

>30% of BSA; associated with
symptoms of pruritus or pain;
associated with psychosocial              Life-threatening consequences;
impact; limiting self care ADL            urgent intervention indicated         Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death




104                                                                                           1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4           Proposed Grade 5




Surgical intervention or IV
antibiotics indicated; limiting self
care ADL                                              -                        -

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death




105                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

         Proposed Grade 3                    Proposed Grade 4           Proposed Grade 5

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or
operative intervention indicated                      -                        -




                   -                                  -                        -

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death




106                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4           Proposed Grade 5




Systemic inflammatory response
syndrome in response to
documented infection (culture or
Gram stain of blood, sputum,
urine, or normally sterile body fluid
positive for pathogenic
microorganism; or focus of
infection identified by visual
inspection, eg, ruptured bowel with
free air or bowel contents found in
abdomen at surgery, wound with
purulent discharge). Signs of
organ hypoperfusion or organ
dysfunction i.e., areas of mottled
skin; capillary refilling of [greater
than or equal to]3 s; urinary output
of <0.5 mL/kg for at least 1 h or
renal replacement therapy; lactate
>2 mmol/L; abrupt change in
mental status or abnormal EEG
findings; platelet count of
<100,000 cells/mL or
disseminated intravascular
coagulation; acute lung
injury/ARDS; and cardiac              Life-threatening consequences;
dysfunction (echocardiography)        urgent intervention indicated          Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death




107                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4           Proposed Grade 5

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated        Death




108                                                                                        1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4              Proposed Grade 5

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death

IV antibiotic, antifungal, or antiviral
intervention indicated; radiologic or Life-threatening consequences;
operative intervention indicated        urgent intervention indicated           Death
                                     Life-threatening consequences;
Severe symptoms; limiting self       evidence of end organ damage;
care ADL; disabling; repair or       urgent operative intervention
revision indicated                   indicated                                  Death
                                     Life-threatening consequences;
Severe symptoms; limiting self       evidence of end organ damage;
care ADL; disabling; repair or       urgent operative intervention
revision indicated                   indicated                                  Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                  Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                  Death



                 -                                     -                          -


                                     Life-threatening consequences;
                                     skin necrosis or ulceration of full
Moist desquamation; bleeding         thickness dermis; spontaneous
induced by minor trauma or           bleeding from involved site; skin
abrasion                             graft indicated                            Death


                                     Life-threatening consequences;
Moist desquamation other than        skin necrosis or ulceration of full
skin folds and creases; bleeding     thickness dermis; spontaneous
induced by minor trauma or           bleeding from involved site; skin
abrasion                             graft indicated                            Death
Severe symptoms; limiting self
care ADL; disabling; operative
intervention indicated (e.g.,
hardware/device replacement or       Life-threatening consequences;
removal, reconstruction)             loss of limb or organ                      Death




109                                                                                           1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4            Proposed Grade 5

Contained leak; medical              Life-threatening consequences;
intervention indicated; operative    urgent operative intervention
intervention not indicated           indicated                                Death



Medical consequences                                   -                        -
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                Death



                                     Life-threatening consequences;
Severe symptoms; elective            urgent operative intervention
operative intervention indicated     indicated (e.g., organ resection)        Death
Severe symptoms; displaced or
open wound with bone exposure;
disabling; operative intervention    Life-threatening consequences;
indicated                            urgent intervention indicated            Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                Death
Severe symptoms; hospitalization
or elective operative intervention   Life-threatening consequences;
indicated                            urgent intervention indicated            Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated             Death
Severe symptoms; limiting self
care ADL (e.g., transient cerebral
ischemia); repair or revision        Life-threatening consequences;
indicated                            urgent intervention indicated            Death

                                     Life-threatening consequences;
                  -                  urgent intervention indicated            Death
Symptomatic limiting self care
ADL; disabling; repair or revision   Life-threatening consequences;
indicated                            urgent intervention indicated            Death



110                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                    Proposed Grade 4          Proposed Grade 5
                                     Life-threatening consequences;
Severe symptoms; limiting self       evidence of end organ damage;
care ADL; disabling; repair or       urgent operative intervention
revision indicated                   indicated                             Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                             Death


Severe symptoms (e.g., altered
dietary habits, vomiting, diarrhea,
or GI fluid loss); IV fluids, tube
feedings, or TPN indicated >=24      Life-threatening consequences;
hrs; elective operative intervention urgent operative intervention
indicated                            indicated                             Death

Transfustion indicated; elective     Life-threatening consequences;
operative intervention indicated     urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Primary repair of injured            Life-threatening consequences;
organ/structure indicated            urgent intervention indicated         Death
Partial resection of injured
organ/structure indicated;
disabling (e.g., impaired hearing;   Life-threatening consequences;
impaired balance)                    urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death




111                                                                                      1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                    Proposed Grade 4          Proposed Grade 5

Postoperative interventional
radiologic, endoscopic, or           Life-threatening consequences;
operative intervention indicated     urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death
Resection or reconstruction of
injured organ/structure indicated;   Life-threatening consequences;
disabling                            urgent intervention indicated         Death

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated         Death




112                                                                                      1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                   Proposed Grade 4              Proposed Grade 5

Complete resection or
reconstruction of injured            Life-threatening consequences;
organ/structure indicated; disabling urgent intervention indicated            Death
Severe symptoms; radiologic,       Life-threatening consequences;
endoscopic or elective operative   urgent operative intervention
intervention indicated             indicated                                  Death
Severe symptoms; radiologic,       Life-threatening consequences;
endoscopic or elective operative   urgent operative intervention
intervention indicated             indicated                                  Death
Severe symptoms; radiologic,       Life-threatening consequences;
endoscopic or elective operative   urgent operative intervention
intervention indicated             indicated                                  Death
Severe symptoms; radiologic,       Life-threatening consequences;
endoscopic or elective operative   urgent operative intervention
intervention indicated             indicated                                  Death


Transfusion indicated of 2 units
(10 cc/kg for pediatrics) pRBCs
beyond protocol specification;
postoperative interventional
radiologic, endoscopic, or         Life-threatening consequences;
operative intervention indicated   urgent intervention indicated              Death
                                   Life-threatening airway
                                   compromise; urgent intervention
Extubated >72 hrs postoperatively, indicated (e.g., tracheotomy or
but before tracheostomy indicated intubation)                                 Death

                                   Life-threatening consequences;
Severe symptoms; elective          urgent operative intervention
operative intervention indicated   indicated                                  Death
Dysfunctional stoma; elective
operative intervention or major    Life-threatening consequences;
stomal revision indicated          urgent intervention indicated              Death


                                   Life-threatening consequences;
Moist desquamation other than      skin necrosis or ulceration of full
skin folds and creases; bleeding   thickness dermis; spontaneous
induced by minor trauma or         bleeding from involved site; skin
abrasion                           graft indicated                            Death
Severe symptoms; radiologic,       Life-threatening consequences;
endoscopic or elective operative   urgent operative intervention
intervention indicated             indicated                                  Death




113                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                      Proposed Grade 4           Proposed Grade 5
Symptomatic, elective
interventional radiology or
operative intervention indicated                       -                        -
Severe symptoms; radiologic,           Life-threatening consequences;
endoscopic or elective operative       urgent operative intervention
intervention indicated                 indicated                              Death
Severe symptoms; radiologic,           Life-threatening consequences;
endoscopic or elective operative       urgent operative intervention
intervention indicated                 indicated                              Death


Symptomatic (e.g., altered dietary
habits, vomiting, diarrhea, ); IV
fluids, tube feedings, or TPN          Life-threatening consequences;
indicated >=12 hrs; elective           urgent operative intervention
operative intervention indicated       indicated                              Death

Severe symptoms; elective
operative intervention indicated                       -                        -


                                Life-threatening consequences;
                                skin necrosis or ulceration of full
                                thickness dermis; spontaneous
Moderate edema; moist           bleeding from involved site; skin
desquamation; >30% BSA affected graft indicated                               Death

Transfusion, radiologic,
endoscopic, or elective operative
intervention indicated (e.g.,          Life-threatening consequences;
hemostasis of bleeding site)           urgent intervention indicated          Death

                                       Life-threatening airway
Stridor; radiologic or endoscopic      compromise; urgent intervention
intervention indicated (e.g., stent,   indicated (e.g., tracheotomy or
laser); limiting self care ADL         intubation)                            Death

Transfusion, radiologic,
endoscopic, or elective operative
intervention indicated (e.g.,          Life-threatening consequences;
hemostasis of bleeding site)           urgent intervention indicated          Death
Severe symptoms; radiologic,           Life-threatening consequences;
endoscopic or elective operative       urgent operative intervention
intervention indicated                 indicated                              Death
Severe symptoms; radiologic,           Life-threatening consequences;
endoscopic or elective operative       urgent operative intervention
intervention indicated                 indicated                              Death



114                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                     Proposed Grade 4              Proposed Grade 5
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                  Death
Altered organ function (e.g.,
sepsis or hydronephrosis, or renal   Life-threatening consequences;
dysfunction); elective operative     organ failure; urgent operative
intervention indicated               intervention indicated                     Death
Transfusion, radiologic,
endoscopic, or operative
intervention indicated (e.g.,        Life-threatening consequences;
hemostasis of bleeding site)         urgent intervention indicated              Death

Symptomatic (e.g.,
hydronephrosis, or renal             Life-threatening consequences;
dysfunction); elective operative     urgent operative intervention
intervention indicated               indicated                                  Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                  Death

Severe symptoms; elective            Life-threatening consequences;
operative intervention indicated     urgent intervention indicated              Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                  Death
Severe symptoms; radiologic,         Life-threatening consequences;
endoscopic or elective operative     urgent operative intervention
intervention indicated               indicated                                  Death


Deep vein or cardiac thrombosis;
intervention indicated (e.g.,
anticoagulation, lysis, filter,      Embolic event including pulmonary
invasive procedure); systemic        embolism or life-threatening
antibiotics indicated                thrombus; sepsis                           Death
                                     Life-threatening consequences;
Severe symptoms; limiting self       evidence of end organ damage;
care ADL; repair or revision         urgent operative intervention
indicated; disabling                 indicated                                  Death
Hernia without evidence of
strangulation; fascial               Hernia with evidence of
disruption/dehiscence; primary       strangulation; major reconstruction
wound closure or revision by         flap, grafting, resection, or
operative intervention indicated     amputation indicated                       Death




115                                                                                           1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                    Proposed Grade 4               Proposed Grade 5



                                    Life-threatening consequences;
                                    symptomatic hernia with evidence
Fascial disruption or dehiscence    of strangulation; fascial disruption
without evisceration; primary       with evisceration; major
wound closure or revision by        reconstruction flap, grafting,
operative intervention indicated    resection, or amputation indicated          Death



> 2.5 x ULN; hemorrhage                               -                           -



>5.0 - 20.0 x ULN                   >20.0 x ULN                                   -

>5.0 - 20.0 x ULN                   >20.0 x ULN                                   -



>5.0 - 20.0 x ULN                   >20.0 x ULN                                   -

                                    Life-threatening consequences;
Hospitalization indicated           urgent intervention indicated                 -

                                    Life-threatening consequences;
Hospitalization indicated           urgent intervention indicated                 -

Severe symptoms; limiting self
care ADL                                              -                           -



                 -                                    -                           -

                 -                                    -                           -


> 8 unit drop (asymptomatic) or >5
unit drop along with the presence
of pulmonary symptoms (e.g.        Life-threatening respiratory or
Grade 2 or higher hypoxia or       hemodynamic compromise;
Grade 2 or higher dyspnea)         intubation or urgent intervention
                                   indicated                                    Death

Levels consistent with myocardial
infarction as defined by the
manufacturer.                                         -                           -




116                                                                                           1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

        Proposed Grade 3                    Proposed Grade 4             Proposed Grade 5
<200 - 50/mm(3) <0.2 x 0.05 -
10e9 /L                             <50/mm(3) <0.05 x 10e9 /L                   -

>5 x ULN - 10 x ULN                 >10 x ULN                                   -
>3.0 baseline; > 3.0 - 6.0 x ULN;
See acute kidney injury             >6.0 x ULN;                                 -



                                    QTc >=501 or >60 msec change
                                    from baseline and Torsade de
                                    pointes or polymorphic ventricular
QTc >=501 msec on at least two      tachycardia or signs/symptoms of
separate EKGs                       serious arrhythmia                        Death
                                    <0.25 x LLN or 75% decrease
<0.5 - 0.25 x LLN or 50 - <75%      from baseline or absolute value
decrease from baseline              <50 mg/dL                                   -
<59% LLN; change PC 20 < 0.125
mg/ml; limiting self care ADL; Life-threatening consequences;
hospitalization indicated      urgent intervention indicated                    -
                               >20.0 x ULN; See underlying
>5.0 - 20.0 x ULN              cause of >20 X GGT elevation                     -



                   -                                 -                          -
                   -                                 -                          -

<8.0 - 6.5 g/dL <4.9 - 4.0 mmol/L   Life-threatening consequences;
<80 - 65 g/L                        urgent intervention indicated             Death
Incease in >4 Gm/dl above ULN or
above baseline if baseline is    Life-threatening consequences;
above ULN                        urgent intervention indicated                  -

> 2.5 x ULN or times above          Life-threatening consequences;
baseline if on anticoagulation      urgent intervention indicated               -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated             Death

                                    >5.0 x ULN; see pancreatitis or
>2.0 - 5.0 x ULN                    other specific organ dysfunction            -




117                                                                                         1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

          Proposed Grade 3                    Proposed Grade 4            Proposed Grade 5

                                      Life-threatening consequences;
Sequelae of absorption deficiency     urgent intervention indicated              -
                                      >5.0 x ULN; See pancreatitis or
                                      other specific source of elevated
>2.0 - 5.0 x ULN                      amylase                                    -
 < 50% of predicted value; limiting
self care ADL; hospitalization        Life-threatening consequences;
indicated                             urgent intervention indicated              -
>=20% from baseline                                     -                        -
>=20% from baseline; tube
feeding or TPN indicated                                 -                       -
                                      pH <7.3; life-threatening
pH <7.3                               consequences                             Death

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated            Death
                                      pH >7.5; life-threatening
pH >7.5                               consequences                             Death
Associated with significant weight
loss or malnutrition (e.g.,
inadequate oral caloric and/or fluid
intake); IV fluids, tube feedings or Life-threatening consequences;
TPN indicated                        urgent intervention indicated             Death

                                      Life-threatening consequences;
IV fluids indicated >=24 hrs          urgent intervention indicated            Death

                                   Life-threatening consequences;
Severe symptoms; insulin indicated urgent intervention indicated               Death
>12.5 - 13.5 mg/dL >3.1 - 3.4
mmol/L Ionized calcium >1.6 -         >13.5 mg/dL >3.4 mmol/L Ionized
1.8 mmol/L; Hospitalization           calcium >1.8 mmol/L; Life-
indicated                             threatening consequences                 Death
>400 - 500 mg/dL >10.34 - 12.92
mmol/L                                >500 mg/dL >12.92 mmol/L                   -
>250 - 500 mg/dL >13.9 - 27.8         >500 mg/dL >27.8 mmol/L
mmol/L                                (consider ketoacidosis)                  Death
>6.0 - 7.0 mmol/L; Hospitalization    >7.0 mmol/L; life-threatening
indicated                             consequences                             Death
>3.0 - 8.0 mg/dL >1.23 - 3.30         >8.0 mg/dL >3.30 mmol/L; life-
mmol/L                                threatening consequences                   -

>155 - 160 mmol/L                     >160 mmol/L                              Death




118                                                                                          1/6/2011
5670fd0d-caf7-414e-91e7-613221e16f45.xls

          Proposed Grade 3                     Proposed Grade 4         Proposed Grade 5

>500mg/dl - 1000mg/dl
(>5.7mmol/L - 11.4mmol/L)              >1000mg/dl (>11.4mmol/L)              Death

>ULN - 10 mg/dL <=0.59 mmol/L
with physiologic consequences          >10 mg/dL >0.59 mmol/L                Death

                                       Life-threatening consequences;
<2 g/dL <20 g/L                        urgent intervention indicated         Death
<7.0 - 6.0 mg/dL <1.75 - 1.5
mmol/L Ionized calcium <0.9 -          <6.0 mg/dL <1.5 mmol/L Ionized
0.8 mmol/L; Hospitalization            calcium <0.8 mmol/L; Life-
indicated                              threatening consequences              Death

<40 - 30 mg/dL <2.2 - 1.7 mmol/L       <30 mg/dL <1.7 mmol/L                 Death

<3.0 - 2.5 mmol/L; Hospitalization     <2.5 mmol/L; life-threatening
indicated                              consequences                          Death

<0.9 - 0.7 mg/dL <0.4 - 0.3 mmol/L <0.7 mg/dL <0.3 mmol/L                    Death

<130 - 120 mmol/L                      <120 mmol/L                           Death

<2.0 - 1.0 mg/dL <0.6 - 0.3 mmol/L <1.0 mg/dL <0.3 mmol/L                    Death

Severe symptoms; intervention          Life-threatening consequences;
indicated                              urgent intervention indicated         Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated            Death

BMI 30 - 39.99 kg/m(2)                 BMI >=40 kg/m(2)                        -

                                       Life-threatening consequences;
Present                                urgent intervention indicated         Death
Operative debridement or other
invasive intervention indicated
(e.g. tissue reconstruction, flap or   Life-threatening consequences;
grafting)                              urgent intervention indicated         Death




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        Proposed Grade 3                      Proposed Grade 4             Proposed Grade 5



Severe pain; limiting self care ADL                    -                          -

Severe pain with inflammation,
erythema, or joint
swelling;irreversible joint damage;
disabling; limiting self care ADL                      -                          -
Severe symptoms; limiting self
care ADL, elective operative
intervention indicated                                 -                          -



Severe pain; limiting self care ADL                    -                          -



Severe pain; limiting self care ADL                    -                          -



Severe pain; limiting self care ADL                    -                          -



Severe pain; limiting self care ADL                    -                          -
Severe symptoms; limiting self
care ADL, elective operative
intervention indicated                                 -                          -

Severe induration; unable to slide
or pinch skin; limiting joint or
orifice movement (e.g. mouth,         Generalized, limiting breathing or
anus); limiting self care ADL         feeding                                   Death



Severe pain; limiting self care ADL                    -                          -




Weakness limiting self care ADL;
disabling                                              -                          -



Reduction in growth velocity of
>=50% ideally measured over the
period of a year                                       -                          -




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        Proposed Grade 3                       Proposed Grade 4          Proposed Grade 5
Operative debridement or other
invasive intervention indicated
(e.g. tissue reconstruction, flap or    Life-threatening consequences;
grafting)                               urgent intervention indicated         Death
Severe symptoms; limiting self
care ADL; elective operative
intervention indicated; disabling                       -                       -



Severe pain; limiting self care ADL                     -                       -
Decreased range of motion
(ROM); limiting self care ADL;
>50% decrease in ROM;
ankylosis; disabling                                    -                       -

Ankylosed/fused over multiple
segments with no C-spine rotation                       -                       -


Less than 50% lumbar spine
flexion; ankylosed or fused over
multiple segments with no L-spine
flexion (e.g., unable to reach to
floor to pick up a very light object)                   -                       -
Severe accentuation; operative
intervention indicated; limiting self
care ADL                                                -                       -
Severe accentuation; operative
intervention indicated; limiting self
care ADL                                                -                       -



Weakness limiting self care ADL;
disabling                                               -                       -




Weakness limiting self care ADL;
disabling                                               -                       -



Weakness limiting self care ADL;
disabling                                               -                       -




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        Proposed Grade 3                      Proposed Grade 4          Proposed Grade 5



Weakness limiting self care ADL;
disabling                                              -                       -




Weakness limiting self care ADL;
disabling                                              -                       -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated            Death

Significant deformity, hypoplasia,
or asymmetry, unable to be
remediated by prosthesis or
covered by clothing; disabling                         -                       -



Severe pain; limiting self care ADL                    -                       -

Pain associated with severe
weakness; limiting self care ADL                       -                       -



Severe pain; limiting self care ADL                    -                       -
Operative debridement or other
invasive intervention indicated
(e.g. tissue reconstruction, flap or   Life-threatening consequences;
grafting)                              urgent intervention indicated         Death

Severe symptoms; limiting self
care ADL, elective operative           Life-threatening consequences;
intervention indicated                 urgent intervention indicated         Death



Loss of height >=2 cm;
hospitalization indicated; limiting
self care ADL                                          -                       -




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        Proposed Grade 3                        Proposed Grade 4              Proposed Grade 5



                  -                                      -                           -



Severe pain; limiting self care ADL                      -                           -
Operative debridement or other
invasive intervention indicated
(e.g. tissue reconstruction, flap or    Life-threatening consequences;
grafting)                               urgent intervention indicated              Death

>45 degrees; scapular prominence
in forward flexion; operative
intervention indicated; limiting self
care ADL; disabling                                      -                           -
Operative debridement or other
invasive intervention indicated
(e.g. tissue reconstruction, flap or    Life-threatening consequences;
grafting)                               urgent intervention indicated              Death
Operative debridement or other
invasive intervention indicated
(e.g. tissue reconstruction, flap or    Life-threatening consequences;
grafting)                               urgent intervention indicated              Death

Severe induration; unable to slide
or pinch skin; limiting joint or
orifice movement (e.g. mouth,           Generalized, limiting breathing or
anus); limiting self care ADL           feeding                                    Death
Decreased range of motion with
inability to adequately aliment or
hydrate orally                                           -                           -
Severe length discrepancy >5 cm;
limiting self care ADL;
disabling;operative intervention
indicated                                                -                           -

Severe symptoms; limiting self
care ADL                                                 -                           -



>1000 ml, symptoms resolve with         >1000 ml, recurrent, not controlled
drainage or pleurodesis                 by pleurodesis                             Death




123                                                                                              1/6/2011
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        Proposed Grade 3                      Proposed Grade 4               Proposed Grade 5



                                      Life-threatening consequences;
                 -                    urgent intervention indicated               Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated                 Death



Non life-threatening secondary        Acute life-threatening secondary
malignancy                            malignancy; blast crisis in leukemia        Death




Severe pain; limiting self care ADL                    -                            -

Severe symptoms; limiting self
care ADL                                               -                            -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated               Death

Severe symptoms; limiting self
care ADL                                               -                            -
Severe restlessness or increased
motor activity; limiting self care
ADL                                                    -                            -
Severe; long term memory loss;
limiting self care ADL                                 -                            -

Voicelessness; unable to speak                         -                            -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated               Death
Severe symptoms; limiting self
care ADL; mechanical assistance
indicated                                              -                            -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated               Death




124                                                                                             1/6/2011
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        Proposed Grade 3                       Proposed Grade 4          Proposed Grade 5

Severe symptoms; medical                Life-threatening consequences;
intervention indicated                  urgent intervention indicated         Death




Severe symptoms; medical                Life-threatening consequences;
intervention indicated                  urgent intervention indicated         Death




Severe cognitive disability;
significant impairment of
work/school/life performance                            -                       -

Severe impairment in attention or
level of concentration; limiting self
care ADL                                                -                       -

Difficult to arouse                     Obtundation; precoma                  Death
Severe unsteadiness or sensation
of movement; limiting self care
ADL                                                     -                       -
Severe impairment of articulation
or slurred speech                                       -                       -

Severe sensory alteration or
paresthesia; limiting self care ADL                     -                       -




                   -                                    -                       -
Severe receptive or expressive
characteristics; impairing ability to
read, write or communicate
intelligibly                                            -                       -

                                        Life-threatening consequences;
                   -                    urgent intervention indicated           -

Severe symptoms; limiting self          Life-threatening consequences;
care ADL                                urgent intervention indicated         Death




125                                                                                         1/6/2011
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        Proposed Grade 3                     Proposed Grade 4          Proposed Grade 5

Severe involuntary movements or       Life-threatening consequences;
torticollis; limiting self care ADL   urgent intervention indicated         Death



Severe symptoms; limiting self
care ADL                                              -                       -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated         Death

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated         Death

Severe pain; limiting self care ADL                   -                       -

Somnolence but responsive to
stimuli; severe disorientation or   Life-threatening consequences;
confusion; clonus and hyperreflexia urgent intervention indicated           Death

Severe symptoms or neurological       Life-threatening consequences;
deficit; intervention indicated       urgent intervention indicated         Death

Severe increased need for sleep                       -                       -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated         Death

Ventriculostomy, ICP monitoring,
intraventricular thrombolysis, or     Life-threatening consequences;
operative intervention indicated      urgent intervention indicated         Death



                  -                                   -                       -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated         Death

                  -                                   -                       -




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        Proposed Grade 3                     Proposed Grade 4             Proposed Grade 5


Severe symptoms; extensive            Life-threatening; extensive
T2/FLAIR hyperintensities,            T2/FLAIR hyperintensities,
involving periventricular white       involving periventricular white
matter involving 2/3 or more of       matter involving most of
susceptible areas of cerebrum +/-     susceptible areas of cerebrum +/-
moderate to severe increase in        moderate to severe increase in
SAS and/or moderate to severe         SAS and/or moderate to severe
ventriculomegaly                      ventriculomegaly                         Death
Severe memory impairment;
limiting self care ADL                                 -                         -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated            Death
Severe symptoms; limiting self
care ADL                                               -                         -

Severe weakness or sensory loss; Life-threatening consequences;
limiting self care ADL           urgent intervention indicated                 Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated              Death

Severe pain; limiting self care ADL                    -                         -
Severe symptoms; limiting self
care ADL                                               -                         -

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated            Death

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated            Death
Severe symptoms; limiting self
care ADL                                               -                         -
Severe symptoms; limiting self
care ADL; assistive device            Life-threatening consequences;
indicated                             urgent intervention indicated            Death

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated            Death




127                                                                                          1/6/2011
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        Proposed Grade 3                     Proposed Grade 4           Proposed Grade 5



Severe pain; limiting self care ADL                   -                        -

                  -                                   -                        -




Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated          Death

Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated          Death

Severe symptoms; medical
intervention indicated (e.g.,         Life-threatening consequences;
thyroplasty, vocal cord injection)    urgent intervention indicated          Death
Severe symptoms; very abnormal
imaging studies; limiting self care   Life-threatening consequences;
ADL                                   urgent intervention indicated          Death
Multiple seizures despite medical     Life-threatening; prolonged
intervention                          repetitive seizures                    Death

Severe pain; limiting self care ADL                   -                        -

                                      Life-threatening consequences;
Obtundation or stupor                 urgent intervention indicated          Death




Severe incease in muscle tone      Life-threatening; unable to move
and increase in resistance through active or passive range of motion;
range of motion                    rigid in flexion and extension            Death

Severe neurologic deficit;            Life-threatening consequences;
symptoms >24 hrs duration             urgent intervention indicated          Death

Fainting; orthostatic collapse                        -                        -




              -                                       -                        -
Severe symptoms; limiting self
care ADL                                              -                        -



128                                                                                        1/6/2011
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          Proposed Grade 3                     Proposed Grade 4              Proposed Grade 5

Severe symptoms; limiting self         Life-threatening consequences;
care ADL                               urgent intervention indicated              Death

Severe symptoms; limiting self         Life-threatening consequences;
care ADL                               urgent intervention indicated              Death

                                       Life-threatening consequences;
Present                                urgent intervention indicated              Death

                                                                             Fetal loss at any
                  -                                      -                    gestational age

Less than 5% percentile of weight      Less than 1% percentile of weight
for gestational age                    for gestational age                        Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated                 Death

Delivery of a liveborn infant at 24+   Delivery of a liveborn infant at 24
to 28 weeks gestation                  weeks of gestation or less                 Death



Unintended pregnancy                                     -                           -

Severe agitation; hospitalization      Life-threatening consequences;
not indicated                          urgent intervention indicated              Death



                  -                                      -                           -
Severe symptoms; limiting self
care ADL; hospitalization not          Life-threatening; hospitalization
indicated                              indicated                                  Death

Severe disorientation; limiting self   Life-threatening consequences;
care ADL                               urgent intervention indicated              Death



                  -                                      -                           -




129                                                                                              1/6/2011
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        Proposed Grade 3                       Proposed Grade 4             Proposed Grade 5

Severe and acute confusional           Life-threatening consequences,
state; limiting self care ADL;         threats of harm to self or others;
hospitalization indicated              hospitalization indicated                 Death

                                       Life-threatening consequences,
Severe delusional symptoms;            threats of harm to self or others;
hospitalization not indicated          hospitalization indicated                 Death

Severe depressive symptoms;            Life-threatening consequences,
limiting self care ADL;                threats of harm to self or others;
hospitalization not indicated          hospitalization indicated                 Death
Severe mood elevation (e.g.,
hypomania)                                               -                         -

                                       Life-threatening consequences,
Severe hallucinations;                 threats of harm to self or others;
hospitalization not indicated          hospitalization indicated                 Death

Severe difficulty in falling asleep,
staying asleep or waking up early                        -                         -



                  -                                      -                         -

Severe increase in sexual interest
leading to dangerous behavior                            -                         -
Severe manic symptoms (e.g.,
hypomania; major sexual or             Life-threatening consequences,
financial indiscretions);              threats of harm to self or others;
hospitalization not indicated          hospitalization indicated                 Death

                                       Life-threatening consequences,
Severe personality change;             threats of harm to self or others;
hospitalization not indicated          hospitalization indicated                 Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated                Death




130                                                                                            1/6/2011
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        Proposed Grade 3                       Proposed Grade 4              Proposed Grade 5
Severe psychotic symptoms (e.g.,
paranoid; extreme                      Life-threatening consequences,
disorganization); hospitalization      threats of harm to self or others;
not indicated                          hospitalization indicated                  Death
Severe symptoms; limiting self
care ADL                                                 -                           -
Specific plan to commit suicide or     Specific plan to commit suicide or
suicide attempt without serious        suicide attempt with serious intent
intent to die which may not require    to die which requires
hospitalization                        hospitalization                               -
Suicide attempt or gesture without
intent to die which may not require Suicide attempt with intent to die
hospitalization                     which requires hospitalization           Completed suicide
Creatinine > 3x baseline or > 4.0
mg/dl; hospitalization indicated;
dialysis not indicated                 Dialysis indicated                         Death
intraperitoneal performation;
elective operating room or             Life-threatening consequences;
interventional radiology               organ failure; urgent operative
intervention indicated                 intervention indicated                     Death

Hospitalization indicated                                 -                          -
15-30 ml/min/1.7 m2, dialysis not       < 15 ml/min/1.7 m2; Dialysis or
indicated                              renal transplant indicated                 Death



Gross hematuria necessitating
transfusion or IV medications;
hospitalization; elective operative,   Life-threatening consequences;
endoscopic or interventional           urgent interventional radiology or
intervention indicated                 operative intervention indicated           Death


Gross hematuria necessitating
transfusion or IV medications;
hospitalization; elective operative,   Life-threatening consequences;
endoscopic or interventional           urgent interventional radiology or
intervention indicated                 operative intervention indicated           Death



-                                                           -                        -

> 3.5 g/d (adult); urine P/C > 1.9
(pediatric)                                                 -                        -




131                                                                                              1/6/2011
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        Proposed Grade 3                       Proposed Grade 4             Proposed Grade 5



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated                Death
Requiring admission ot the
hospital; use of intravenous
medications (for Pain or               Life-threatening consequences;
antiemetics); planned endoscopic       urgent endoscopic or
or interventional radiology            interventional radiology
intervention                           intervention indicated                    Death



Hospitalization indicated                                -                         -
Symptoms requiring
hospitalization; transfusion;
radiation; elective operating room     Life-threatening consequences;
or interventional radiology            urgent interventional radiology or
intervention indicated                 operative intervention indicated          Death
Symptomatic limiting self care
ADL; elective operating room or
interventional radiology
intervention indicated;                Life-threatening consequences;
permanent urinary diversion            urgent interventional radiology or
indicated                              operative intervention indicated          Death
Limiting self care ADL;
intervention indicated (e.g., clamp,
collagen injections); operative
intervention indicated                                   -                         -

Severe pain; limiting self care ADL                      -                         -

Elective operative or radiologic
intervention indicated; substantial    Life-threatening consequences;
loss of affected kidney function or    organ failure; urgent operative
mass                                   intervention indicated                    Death


Symptomatic and altered organ
function (e.g. hydronephrosis, or
renal dysfunction); elective
operating room, endoscopic or
interventional radiology               Life-threatening consequences;
intervention indicated                 urgent intervention indicated             Death



132                                                                                            1/6/2011
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        Proposed Grade 3                        Proposed Grade 4            Proposed Grade 5

-                                                         -                        -

Absence of sperm in ejaculate                             -                        -
Asymmetry exists, >1/3 of the
breast volume; severe atrophy                             -                        -

Severe pain; limiting self care ADL                       -                        -

Severe discomfort or pain
associated with vaginal
penetration; no relief from use of
vaginal lubricants/estrogen                               -                        -

                  -                                       -                        -


Decrease in erectile function
(frequency/rigidity of erections) but
erectile intervention not helpful
(e.g., medication or mechanical
devices such as penile pump);
placement of a permanent penile
prosthesis indicated (not
previously present)                                       -                        -

Severe symptoms; elective
operative intervention indicated                          -                        -



                                        Life-threatening consequences;
Severe symptoms; elective               urgent operative intervention
operative intervention indicated        indicated (e.g., organ resection)        Death

Severe symptoms; elective               Life-threatening consequences;
operative intervention indicated        urgent intervention indicated            Death

                  -                                       -                        -



Lymphorrhea; gross deviation from
normal anatomic contour; limiting
self care ADL                                             -                        -
Severe symptoms; elective
operative intervention indicated                          -                        -




133                                                                                            1/6/2011
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          Proposed Grade 3                   Proposed Grade 4          Proposed Grade 5

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                               Death




                  -                                   -                       -
Severe; transfusion indicated;
surgical intervention indicated       Life-threatening consequences;
(e.g., hysterectomy)                  urgent intervention indicated         Death




                 -                                    -                       -
Sperm concentration <13
million/mL or motility <32%                           -                       -

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                               Death
Transfusion, radiologic,
endoscopic, or elective operative     Life-threatening consequences;
intervention indicated                urgent intervention indicated         Death

Severe pain; limiting self care ADL                   -                       -



Severe symptoms; limiting self        Life-threatening consequences;
care ADL                              urgent intervention indicated         Death

Severe pain; limiting self care ADL                   -                       -

Severe pain; limiting self care ADL                   -                       -

Severe pain; limiting self care ADL                   -                       -

Present                                               -                       -


Severe symptoms; interfering with
urination or sexual function;
limiting self care ADL; elective
operative intervention or stent       Life-threatening consequences;
placement indicated                   urgent intervention indicated         Death



134                                                                                       1/6/2011
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        Proposed Grade 3                     Proposed Grade 4          Proposed Grade 5

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                               Death

Severe symptoms; elective
operative intervention indicated                      -                       -

Severe pain; limiting self care ADL                   -                       -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated           Death

Severe pain; limiting self care ADL                   -                       -

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                               Death

Severe symptoms; elective
operative intervention indicated                      -                       -

Severe symptoms; interfering with
urination or sexual function;
limiting self care ADL; intervention Life-threatening consequences;
indicated                            urgent intervention indicated          Death

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                               Death

Severe pain; limiting self care ADL                   -                       -

Severe symptoms; elective             Life-threatening consequences;
operative intervention indicated      urgent intervention indicated         Death

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                               Death




135                                                                                       1/6/2011
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        Proposed Grade 3                      Proposed Grade 4           Proposed Grade 5

Severe symptoms; elective
operative intervention indicated                       -                        -

Severe pain; limiting self care ADL                    -                        -



                  -                                    -                        -

Severe vaginal dryness resulting
in dyspareunia or severe
discomfort                                             -                        -

Severe symptoms; elective             Life-threatening consequences;
operative intervention indicated      urgent intervention indicated           Death

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                                 Death
                                    Widespread areas of mucosal
Severe discomfort or pain, edema, ulceration; life-threatening
or redness; limiting self care ADL; consequences; urgent intervention
small areas of mucosal ulceration indicated                                   Death

Symptomatic obstruction of the
vagina precluding sexual function     Life-threatening consequences;
and physical examination              urgent intervention indicated           Death

Severe pain; limiting self care ADL                    -                        -

Severe symptoms; elective             Life-threatening consequences;
operative intervention indicated      urgent intervention indicated           Death
Vaginal narrowing and/or
shortening interfering with the use
of tampons, sexual activity or        Complete obliteration of vaginal
physical examination                  canal                                   Death
Severe discomfort or pain
associated with vaginal spasm/
tightening; unable to tolerate
vaginal penetration or physical
examination                                            -                        -

Severe bleeding; transfusion        Life-threatening consequences;
indicated; radiologic or endoscopic urgent operative intervention
intervention intervention indicated indicated                                 Death



136                                                                                         1/6/2011
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        Proposed Grade 3                      Proposed Grade 4             Proposed Grade 5

Severe symptoms; elective
operative intervention indicated                        -                         -
                                      Life-threatening respiratory or
                                      hemodynamic compromise;
Present with radiologic findings;     intubation or urgent intervention
intubation not indicated              indicated                                 Death



                  -                                     -                         -
                                      Life-threatening respiratory or
                                      hemodynamic compromise;
Present; medical intervention         intubation or urgent intervention
indicated                             indicated                                 Death

Dyspnea and pneumonia                 Life-threatening respiratory or
symptoms (e.g., aspiration            hemodynamic compromise;
pneumonia) hospitalization            intubation or urgent intervention
indicated; unable to aliment orally   indicated                                 Death

Oxygen therapy indicated;             Life-threatening respiratory or
hospitalization or elective           hemodynamic compromise;
operative intervention indicated      intubation or urgent intervention
(e.g., stent, laser)                  indicated                                 Death


                                      Life-threatening consequences;
Severe symptoms; limiting self        urgent operative intervention with
care ADL; endoscopic or operative     thoracoplasty, chronic open
intervention indicated (e.g., stent   drainage or multiple thoracotomies
or primary closure)                   indicated                                 Death

Transfusion, radiologic,              Life-threatening respiratory or
endoscopic, or elective operative     hemodynamic compromise;
intervention indicated (e.g.,         intubation or urgent intervention
hemostasis of bleeding site)          indicated                                 Death




                                      Life-threatening respiratory or
Shortness of breath with stridor;     hemodynamic compromise;
endoscopic intervention indicated     intubation or urgent intervention
(e.g., laser, stent placement)        indicated                                 Death




137                                                                                           1/6/2011
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        Proposed Grade 3                        Proposed Grade 4            Proposed Grade 5

                                        Life-threatening respiratory or
Shortness of breath with stridor;       hemodynamic compromise;
endoscopic intervention indicated       intubation or urgent intervention
(e.g., laser, stent placement)          indicated                                Death
Transfusion, radiologic,                Life-threatening respiratory or
endoscopic, or operative                hemodynamic compromise;
intervention indicated (e.g.,           intubation or urgent intervention
hemostasis of bleeding site)            indicated                                Death
                                        Life-threatening respiratory or
                                        hemodynamic compromise;
Limiting self care ADL; oxygen          intubation or urgent intervention
saturation decreased                    indicated                                Death
                                        Life-threatening respiratory or
                                        hemodynamic compromise;
Severe symptoms; elective               intubation or urgent intervention
operative intervention indicated        indicated                                Death

Severe symptoms; interfering with
sleep; limiting self care ADL                             -                        -
Symptomatic (e.g., abnormal
sensation, itching, burning, tingling
of the throat); no respiratory          Life-threatening respiratory or
distress; medical intervention          hemodynamic compromise;
indicated (e.g., steroids,              intubation or urgent intervention
epinephrine)                            indicated                                Death



Shortness of breath limiting self       Life-threatening consequences;
care ADL                                urgent intervention indicated            Death
Transfusion, radiologic,
endoscopic, or operative
intervention indicated (e.g.,           Life-threatening consequences;
hemostasis of bleeding site)            urgent intervention indicated            Death

Severe symptoms; interfering with
sleep; limiting self care ADL                             -                        -




Severe voice changes including
predominantly whispered speech                            -                        -




138                                                                                            1/6/2011
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        Proposed Grade 3                      Proposed Grade 4              Proposed Grade 5



                                      Life-threatening airway
Hypoxia at rest, with O(2)            compromise; urgent intervention
saturation < or =88% or PaO(2) <      indicated (e.g., tracheotomy or
or =55.                               intubation)                                Death
                                      Life-threatening airway
                                      compromise; urgent intervention
Stridor; respiratory distress;        indicated (e.g., tracheotomy or
hospitalization indicated             intubation)                                Death


                                      Life-threatening consequences;
Severe symptoms; limiting self        urgent operative intervention with
care ADL; endoscopic or operative     thoracoplasty, chronic open
intervention indicated (e.g., stent   drainage or multiple thoracotomies
or primary closure)                   indicated                                  Death
Transfusion, radiologic,              Life-threatening airway
endoscopic, or operative              compromise; urgent intervention
intervention indicated (e.g.,         indicated (e.g., tracheotomy or
hemostasis of bleeding site)          intubation)                                Death

Severe throat pain; endoscoptic
intervention indicated                                 -                           -
                                      Life-threatening airway
Severe pain; severely altered         compromise; urgent intervention
eating/swallowing; medical            indicated (e.g., tracheotomy or
intervention indicated                intubation)                                Death



Limiting self care ADL; stridor;
endoscopic intervention indicated     Life threatening consequences;
(e.g., stent, laser)                  urgent intervention indicated              Death



Limiting self care ADL; stridor;
endoscopic intervention indicated     Life threatening consequences;
(e.g., stent, laser)                  urgent intervention indicated              Death
Severe symptoms; dyspnea and
swallowing diffculty; limiting self
care ADL; inpatient observation       Life-threatening episode; inpatient
not indicated                         observation indicated                      Death




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        Proposed Grade 3                       Proposed Grade 4               Proposed Grade 5
                                       Persistent or severe episodes
Recurrent episodes; non-invasive       associated with syncope; urgent
intervention indicated (e.g.,          intervention indicated (e.g.,
breathing technique, pressure          fiberoptic laryngoscopy, intubation,
point massage)                         botox injection)                            Death

Transfusion, radiologic,
endoscopic, or elective operative
intervention indicated (e.g.,          Life-threatening consequences;
hemostasis of bleeding site)           urgent intervention indicated               Death

Associated with bloody nasal
discharge or epistaxis                                   -                           -

Severe symptoms; limiting self
care ADL; endoscopic or operative
intervention indicated (e.g., stent Life threatening consequences;
or primary closure)                 urgent intervention indicated                  Death
Transfusion, radiologic,               Life-threatening respiratory or
endoscopic, or operative               hemodynamic compromise;
intervention indicated (e.g.,          intubation or urgent intervention
hemostasis of bleeding site)           indicated                                   Death

Severe pain; unable to adequately
aliment or hydrate orally; limiting    Life threatening consequences;
self care ADL                          urgent intervention indicated               Death
Inability to aliment adequately by
GI tract (e.g., requiring enteral or
parenteral nutrition); radiologic,     Life-threatening consequences;
endoscopic, or operative               urgent operative intervention
intervention indicated                 indicated                                   Death

                                       Life-threatening airway
Limiting self care ADL; stridor;       compromise; urgent intervention
endoscopic intervention indicated      indicated (e.g., tracheotomy or
(e.g., stent, laser)                   intubation)                                 Death



Severe pain; limiting self care ADL                      -                           -


Symptomatic with respiratory
distress and hypoxia; more than        Life-threatening respiratory or
two thoracenteses, surgical            hemodynamic compromise;
intervention including chest tube or   intubation or urgent intervention
pleurodesis indicated                  indicated                                   Death



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        Proposed Grade 3                        Proposed Grade 4              Proposed Grade 5


                                        Life-threatening consequences;
Severe symptoms; limiting self          urgent operative intervention with
care ADL; endoscopic or operative       thoracoplasty, chronic open
intervention indicated (e.g., stent     drainage or multiple thoracotomies
or primary closure)                     indicated                                  Death


Greater than 1000ml of blood
evacuate, continued bleeding (150-      Life-threatening respiratory or
200ml/hr for 2-4 hr), persistent        hemodynamic compromise;
transfusion ; elective operative        intubation or urgent intervention
intervention indicated                  indicated                                  Death



Severe pain; limiting self care ADL                       -                          -
                                        Life-threatening airway
                                        compromise; urgent intervention
Severe symptoms; limiting self          indicated (e.g., tracheotomy or
care ADL; O(2) indicated                intubation)                                Death



Sclerosis and/or operative              Life-threatening consequences;
intervention indicated                  urgent intervention indicated              Death



                  -                                       -                          -
Persistent/copious production of
sputum with cough; limiting self
care ADL                                                  -                          -
                                        Life-threatening respiratory
Severe dyspnea or dyspnea at            compromise; urgent intervention or
rest; requiring oxygen; limiting self   intubation with ventilatory support
care ADLs                               indicated                                  Death



                                    Life-threatening consequences;
                                    hemodynamic/pulmonary
Severe hypoxemia; evidence of       complications; intubation with
right-sided heart failure;          ventilatory support required;
radiographic pulmonary fibrosis 50- radiographic pulmonary fibrosis >
75%                                 75% with severe honeycombing                   Death

Altered respiration limiting self Life-threatening cardiopulmonary
care ADLs; endoscopic stenting or complications; urgent operative
operative intervention indicated  intervention indicated                           Death



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        Proposed Grade 3                      Proposed Grade 4              Proposed Grade 5
Transfusion, radiologic,              Life-threatening respiratory or
endoscopic, or operative              hemodynamic compromise;
intervention indicated (e.g.,         intubation or urgent intervention
hemostasis of bleeding site)          indicated                                  Death
                                 Life-threatening airway
Severe symptoms, associated with compromise; urgent intervention
hypoxemia, right heart failure;  indicated (e.g., tracheotomy or
oxygen required                  intubation)                                     Death

                                      Life-threatening consequences;
                                      urgent intervention, intubation, or
                  -                   ventilatory support indicated              Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated                Death



Severe symptoms; hospitalization      Life-threatening consequences;
indicated                             ventilatory support indicated              Death
                                      Necrosis of soft tissue or bone;
Stenosis with significant nasal       urgent operative intervention
obstruction; limiting self care ADL   indicated                                  Death
Oxygen desaturation; associated
with hypertension; medical            Cardiovascular or neuropsychiatric
intervention indicated; limiting self symptoms; urgent operative
care ADL                              intervention indicated                     Death



                  -                                     -                          -



Severe pain; limiting self care ADL                     -                          -
                                      Life-threatening airway
Respiratory distress limiting self    compromise; urgent intervention
care ADL; medical intervention        indicated (e.g., tracheotomy or
indicated                             intubation)                                Death




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        Proposed Grade 3                       Proposed Grade 4             Proposed Grade 5


                                       Life-threatening consequences;
Severe symptoms; limiting self         urgent operative intervention with
care ADL; endoscopic or operative      thoracoplasty, chronic open
intervention indicated (e.g., stent    drainage or multiple thoracotomies
or primary closure)                    indicated                                 Death
Severe pain, bleeding, or
respiratory symptoms limiting self     Life-threatening consequences;
care ADL                               urgent intervention indicated             Death

Stridor or respiratory distress        Life-threatening airway
limiting self care ADL; endoscopic     compromise; urgent intervention
intervention indicated (e.g., stent,   indicated (e.g., tracheotomy or
laser)                                 intubation)                               Death


Severe voice changes including
predominantly whispered speech;
may require frequent repetition or
face-to-face contact for
understandability; may require
assistive technology                                    -                          -
Severe respiratory symptoms
limiting self care ADL; oxygen
therapy indicated; hospitalization     Life-threatening consequences;
indicated                              urgent intervention indicated             Death



Hair loss >74%; associated with
marked increase in shedding and
is apparent to others. May be
difficult to camouflage with hair
style change; may require hair
piece but not generally wig                             -                          -



                  -                                     -                          -
                                       Blisters covering >30%
                                       BSA;limiting self care; associated
                                       with fluid or electrolyte
Blisters covering >30% BSA;            abnormalities; ICU care or burn
limiting self care ADL                 unit indicated                            Death



Covering >30% BSA; associated
with pruritus limiting self care ADL                    -                          -



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        Proposed Grade 3                      Proposed Grade 4              Proposed Grade 5
                                      Target lesions covering >30%
Target lesions covering >30%          BSA; associated with fluid or
BSA; associated with oral or          electrolyte abnormalities, ICU care
genital erosions                      indicated                                  Death

>90% BSA with associated            Associated fluid or electrolyte
symptoms (e.g., pruirtus or         abnormalities with indication for
tenderness); limiting self care ADL ICU or burn unit care                        Death

Covering >30% BSA; associated
with erythema or tenderness                            -                           -
Generalized hyperhidrosis
involving sites other than palms,
soles, or axillae                                      -                           -


Very dense increased hair growth
that requires daily treatment to
camouflage or treatment with laser
or electrolysis. Without treatment,
patient is unable to function in
social, personal or professional
situations.                                            -                           -



Increase in body temperature          Heat stroke                                Death

Covering >30% BSA; associated
tenderness requiring narcotics or
NSAIDs; lipohypertrophy limiting
self care ADL                                          -                           -



                 -                                     -                           -




                 -                                     -                           -



                 -                                     -                           -



Severe pain; limiting self care ADL                    -                           -




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        Proposed Grade 3                      Proposed Grade 4             Proposed Grade 5
Skin changes (e.g., peeling,
blisters, bleeding, edema, or
hypekeratosis) with pain, limiting
self care ADL                                          -                          -


Edema associated with visual
disturbance; increased intraocular
pressure, glaucoma or retinal
hemorrhage; optical neuritis;
edema and diuretic indicated;
surgical intervention indicated                        -                          -


Erythema covering >30% BSA;
erythema with blistering;
photosensitivity requiring oral
corticosteroid therapy OR             Life-threatening consequences;
narcotics/NSAIDs for pain control     urgent intervention indicated             Death



Intense or widespread, constant,
limiting self care ADL or sleep;
oral corticosteroid or
immunosuppressive therapy
indicated                                              -                          -

Combined area of lesions covering
>30% BSA; spontaneous bleeding                         -                          -

>30% of BSA; associated with          >30% of BSA; associated with
symptoms of pruritus or pain;         extensive superinfection requiring
associated with psychosocial          intravenous antibiotics or
impact; limiting self care ADL        hospitalization                           Death

Macules/papules with or without
associated symptoms covering
>30% BSA                                               -                          -



Severe pain; limiting self care ADL                    -                          -




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        Proposed Grade 3                     Proposed Grade 4             Proposed Grade 5



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated              Death



Covering >30% BSA; associated
ulceration                                             -                         -



                  -                                    -                         -




                  -                                    -                         -

Severe induration, unable to slide
or pinch skin; limiting joint
movement or orifice (e.g. mouth,     Generalized, limiting breathing or
anus); limiting self care ADL        feeding                                   Death


Combined area of ulcers >2cm;        Any size ulcer with extensive
full-thickness skin loss involving   destruction, tissue necrosis, or
damage to or necrosis of             damage to muscle, bone, or
subcutaneous tissue that may         supporting structures with or
extend down to fascia.               without full thickness skin loss          Death
<10% BSA with associated             10 - 30% BSA with associated
symptoms (e.g., erythema,            symptoms (e.g., erythema,
purpura, epidermal detachment        purpura, epidermal detachment
and mucous membrane                  and mucous membrane
detachment)                          detachment)                               Death



Many and confluent                                     -                         -

                                     >=30% BSA with associated
                                     symptoms (e.g., erythema,
                  -                  purpura, or epidermal detachment)         Death

>30% BSA; IV intervention
indicated                                              -                         -




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        Proposed Grade 3                     Proposed Grade 4            Proposed Grade 5
Menopause occurring before age
40 years of age                                       -                         -



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated             Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated             Death

Severe symptoms; intervention        Life-threatening consequences;
indicated                            urgent intervention indicated            Death

Symptomatic, associated with
hypotension and/or tachycardia                        -                         -
Transfusion, radiologic,
endoscopic, or elective operative    Life-threatening consequences;
intervention indicated               urgent intervention indicated            Death
Severe symptoms; limiting self
care ADL                                              -                         -

Stage 2 hypertension, systolic BP    Life-threatening, malignant
>= 160 or diastolic BP >=100 mm      hypertension, urgent intervention
Hg, medical intervention indicated   indicated                                Death

                                     Life-threatening and urgent
Medical intervention indicated       intervention indicated (consider
(consider etiology of hypotension)   etiology of hypotension)                 Death
Severe symptoms; radiologic,
endoscopic or elective operative     Life-threatening consequences;
intervention indicated               urgent intervention indicated            Death

Severe symptoms; limiting self
care ADL                                              -                         -
Severe symptoms; radiologic,
endoscopic or elective operative
intervention indicated                                -                         -




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        Proposed Grade 3                    Proposed Grade 4             Proposed Grade 5
                                    Life-threatening consequences;
Recurring or prolonged (>=24 hrs)   evidence of end organ damage;
and/or invasive intervention        urgent operative intervention
indicated                           indicated                                 Death

                 -                                   -                          -

                 -                                   -                          -

Severe symptoms; multi-modality     Life-threatening consequences;
intervention indicated (e.g.,       urgent multi-modality intervention
anticoagulation, chemotherapy,      indicated (e.g., lysis,
radiation, stenting)                thrombectomy, surgery)                    Death


                                    Life-threatening (e.g. pulmonary
Thrombosis (e.g.uncomplicated       embolism, cerebrovascular event,
pulmonary embolism [venous],        arterial insufficiency);
non-embolic cardiac mural           hemodynamic or neurologic
[arterial] thrombus, medical        instability, urgent intervention
intervention indicated              indicated                                 Death



Severe or medically significant but
not immediately life-threatening;
hospitalization or prolongation of
existing hospitalization indicated. Life-threatening consequences;
Disabling; limiting self care ADL   urgent intervention indicated             Death

Severe symptoms; medical            Life-threatening; evidence of
intervention indicated (e.g.        peripheral or visceral ischemia;
steroids)                           urgent intervention indicated.            Death
                                    Life-threatening consequences;
Prolonged (>=24 hrs) or recurring   evidence of end organ damage;
symptoms and/or invasive            urgent operative intervention
intervention indicated              indicated                                 Death




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               SOC                            Proposed AE Term                                                         Draft Definition
                                                                          A laboratory finding indicating decreased number of hematopoietic cells in the bone marrow. It may
Blood and lymphatic system                                                result from decreased proliferation of all or part of the hematopoietic series (erythroid, myeloid, and
disorders                    Bone marrow hypocellular                     megakaryocytic).

Blood and lymphatic system                                                A pathological process where the blood starts to coagulate throughout the whole body. This depletes
disorders                    Disseminated intravascular coagulation       the body of its platelets and coagulation factors, and there is an increased risk of hemorrhage.
Blood and lymphatic system
disorders                    Febrile neutropenia                          Neutropenia associated with fever, indicating the presence of an infection.
Blood and lymphatic system
disorders                    Hemoglobin decreased                         A laboratory test result which indicates decreased levels of hemoglobin in a biological specimen.
Blood and lymphatic system
disorders                    Hemolysis                                    Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin.
Blood and lymphatic system                                                A form of thrombotic microangiopathy with renal failure, hemolytic anemia, and severe
disorders                    Hemolytic uremic syndrome                    thrombocytopenia and purpura.
Blood and lymphatic system
disorders                    Leukocytosis                                 A laboratory test result indicating an increased number of white blood cells in the peripheral blood.
Blood and lymphatic system
disorders                    Leukopenia                                   A laboratory test result indicating a decreased number of white blood cells in the peripheral blood.
Blood and lymphatic system
disorders                    Lymph node pain                              A painful sensation in a lymph node.
Blood and lymphatic system                                                A laboratory test result indicating an abnormal increase in the number of lymphocytes in the peripheral
disorders                    Lymphocytosis                                blood, effusions, or bone marrow.
Blood and lymphatic system
disorders                    Lymphopenia                                  A decreased number of lymphocytes in the circulating blood.
Blood and lymphatic system                                                A decrease in the number of mature granulocytes (neutrophils, eosinophils, and basophils) in the
disorders                    Neutropenia                                  peripheral blood.
Blood and lymphatic system
disorders                    Spleen disorder                              An abnormality of the spleen
Blood and lymphatic system
disorders                    Thrombocytopenia                             A condition in which there decreased number of platelets in the circulating blood.
                                                                          An acute or subacute syndrome characterized by the presence of microangiopathic hemolytic anemia,
Blood and lymphatic system                                                thrombocytopenic purpura, fever, renal abnormalities and neurologic abnormalities such as seizures,
disorders                    Thrombotic thrombocytopenic purpura          hemiplegia, and visual disturbances.
                                                                          Signs and symptoms related to acute ischemia of the myocardium secondary to coronary artery
                                                                          disease. The clinical presentation covers a spectrum of heart diseases from unstable angina to
Cardiac disorders            Acute coronary syndrome                      myocardial infarction.
Cardiac disorders            Aortic valve disease                         A heart disorder characterized by a defect in aortic valve structure or function.
                                                                          Sudden cessation of the pumping function of the heart, with disappearance of arterial blood pressure,
Cardiac disorders            Asystole                                     connoting either ventricular fibrillation or ventricular standstill.

                                                                          A supraventricular arrhythmia characterized by uncoordinated atrial myocardium activation due to
Cardiac disorders            Atrial fibrillation                          multiple reentry circuits with consequent deterioration of atrial mechanical function.
                                                                          An electrocardiographic finding of an organized rhythmic contraction of the atria which is generally at a
Cardiac disorders            Atrial flutter                               rate of 200-300 beats per minute.

Cardiac disorders            Atrioventricular block complete              Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

                                                                          A delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV)
Cardiac disorders            Atrioventricular block first degree          node beyond 0.2 seconds; prolongation of the PR interval beyond 200 milliseconds.




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Cardiac disorders   Cardiac arrest                                   Sudden cessation of the pumping function of the heart, with disappearance of arterial blood pressure.
Cardiac disorders   Chest pain - cardiac                             A heart condition marked by paroxysms of chest pain due to reduced oxygen to the heart.

Cardiac disorders   Conduction disorder                              A disorder affecting the conduction system that sends electrical signals in the myocardium.
                                                                     A heart disorder in which the pericardial sac becomes thickened and fibrotic, tightening the
Cardiac disorders   Constrictive pericarditis                        myocardium and impeding the normal myocardial function.
                                                                     Inability of the heart to pump blood at an adequate rate to meet tissue metabolic requirements or the
Cardiac disorders   Heart failure                                    ability to do so only at an elevated filling pressure.
                                                                     Failure of adequate output by the left ventricle despite an increase in distending pressure and in end-
                                                                     diastolic volume. Cinical manifestations include dyspnea, orthopnea, and other signs and symptoms of
Cardiac disorders   Left ventricular failure                         pulmonary congestion and edema.
Cardiac disorders   Mitral valve disease                             A heart disorder characterized by a defect in mitral valve structure or function.

                                                                     Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the
Cardiac disorders   Mobitz (type) II atrioventricular block          ventricles, characterized by a relatively constant PR interval prior to the block of an atrial impulse.
                                                                     Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the
                                                                     ventricles, characterized by a progressively lengthening PR interval prior to the block of an atrial
Cardiac disorders   Mobitz type I                                    impulse.
                                                                     Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area, as in
Cardiac disorders   Myocardial infarction                            coronary thrombosis.
Cardiac disorders   Myocarditis                                      Inflammation of the muscle tissue of the heart.
Cardiac disorders   Palpitations                                     An unpleasant sensation of irregular and/or forceful beating of the heart.
Cardiac disorders   Paroxysmal atrial tachycardia                    An episodic form of atrial tachycardia, with abrupt onset and termination.
Cardiac disorders   Pericardial effusion                             Fluid collection within the pericardial sac, usually due to inflammation.

                                                                     Acute compression of the heart caused by increased intrapericardial pressure due to the collection of
Cardiac disorders   Pericardial tamponade                            blood or fluid in the pericardium from rupture of the heart, penetrating trauma, or progressive effusion.
Cardiac disorders   Pericarditis                                     An inflammatory process affecting the pericardium.
Cardiac disorders   Pulmonary valve disease                          A heart disorder characterized by a defect in pulmonary valve structure or function.
                                                                     A type of heart disorder referring to the inability of the ventricles to fill with blood because the
Cardiac disorders   Restrictive cardiomyopathy                       myocardium (heart muscle) stiffens and looses its flexibility.
                                                                     Impairment of the right ventricular function associated with low ejection fraction and decreased motility
Cardiac disorders   Right ventricular dysfunction                    of the right ventricular wall.

                                                                     A constellation of signs and symptoms which may include syncope, fatigue, dizziness, and alternating
Cardiac disorders   Sick sinus syndrome                              periods of bradycardia and atrial tachycardia, which is caused by sinoatrial node dysfunction.
Cardiac disorders   Sinus bradycardia                                A heart rate of less than 60 beats per minute, with its origin in the sinus node.
Cardiac disorders   Sinus tachycardia                                A heart rate of more than 100 beats per minute, with its origin in the sinus node.

                                                                     Obstruction of the blood flow in the superior vena cava caused by a malignant neoplasm, thrombosis,
                                                                     or aneurysm. It is a medical emergency requiring immediate treatment. Signs and symptoms include
Cardiac disorders   Superior vena caval syndrome                     swelling and cyanosis of the face, neck, and upper arms, cough, orthopnea, and headache.
Cardiac disorders   Supraventricular tachycardia                     Tachyarrhythmia originating either from the atria or the atrioventricular node.
Cardiac disorders   Tricuspid valve disease                          A heart disorder characterized by a defect in tricuspid valve structure or function.
Cardiac disorders   Ventricular arrhythmia                           Irregular heart beat resulting from a pathologic process in the cardiac ventricles.
                                                                     Arrhythmia characterized by fibrillary contractions of the ventricular muscle due to rapid repetitive
Cardiac disorders   Ventricular fibrillation                         excitation of myocardial fibers without coordinated contraction of the ventricle.
Cardiac disorders   Ventricular tachycardia                          A tachycardia arising distal to bundle of His, with a rate greater than 100 beats per minute.




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                                                                           A congenital electrical function abnormality in the heart. It is characterized by the presence of an
                                                                           accessory conductive pathway between the atria and the ventricles which causes the activation of the
Cardiac disorders                  Wolff-Parkinson-White Syndrome          ventricles earlier than anticipated.
Congenital, familial and genetic
disorders                          Congenital anomaly                      Any abnormality, anatomical or biochemical, evident at birth or during the neonatal period.
Ear and labyrinth disorders        Ear pain                                Earache; a pain localized in the middle or inner ear.

Ear and labyrinth disorders        External ear inflammation               An acute or chronic inflammatory process involving the skin of the outer ear and the ear canal.
Ear and labyrinth disorders        External ear pain                       Painful sensation in the external ear region.
                                                                           Partial or complete loss of the ability to detect or understand sounds resulting from damage to the
Ear and labyrinth disorders        Hearing impaired                        outer, middle, or inner ear structures.
Ear and labyrinth disorders        Middle ear inflammation                 An acute or chronic inflammatory process affecting the middle ear.
Ear and labyrinth disorders        Tinnitus                                A noise in the ears, such as ringing, buzzing, roaring, clicking.

                                                                           Vertigo is a feeling of movement, a sensation as if the external world were revolving around the patient
Ear and labyrinth disorders        Vertigo                                 (objective vertigo) or as if he himself were revolving in space (subjective vertigo).
                                                                           A non-neoplastic or neoplastic disorder affecting the inner ear. Causes are inner ear infections, head
                                                                           injuries, and neoplasms (e.g., acoustic schwannoma). Symptoms include dizziness, imbalance,
Ear and labyrinth disorders        Vestibular disorder                     nausea, and vision problems.
                                                                           An endocrine or hormonal disorder that occurs when the adrenal cortex does not produce enough of
                                                                           the hormone cortisol and in some cases, the hormone aldosterone. It may be due to a disorder of the
                                                                           adrenal cortex (Addison's disease or primary adrenal insufficiency; Failure of the adrenal gland to
Endocrine disorders                Adrenal insufficiency                   produce adequate levels of steroid hormones.
                                                                           Resembling the signs and symptoms of Cushing's disease or syndrome: buffalo hump obesity,
                                                                           striations, adiposity, hypertension, diabetes, and osteoporosis, usually due to exogenous
Endocrine disorders                Cushingoid                              corticosteroids.
Endocrine disorders                Delayed puberty                         Unusually late sexual maturity.
Endocrine disorders                Growth accelerated                      Growth greater than expected for age.

                                                                           An endocrine disorder characterized by increased production of parathyroid hormone by the
Endocrine disorders                Hyperparathyroidism                     parathyroid glands, resulting in abnormally high levels of calcium in the blood (hypercalcemia).

                                                                            Excess of thyroid hormone resulting from an overactive thyroid gland (or taking too much thyroid
Endocrine disorders                Hyperthyroidism                         hormone). Symptoms can include increased heart rate, weight loss, depression, and cognitive slowing
                                                                           An endocrine disorder characterized by decreased production of parathyroid hormone by the
Endocrine disorders                Hypoparathyroidism                      parathyroid glands.
                                                                           A condition in which the production of thyroid hormone by the thyroid gland is diminished. Signs and
                                                                           symptoms of hypothyroidism include low metabolic rate, tendency to weight gain, somnolence and
Endocrine disorders                Hypothyroidism                          sometimes myxedema.
                                                                           The unusually early development of secondary sexual features; the onset of sexual maturation begin
Endocrine disorders                Precocious puberty                      before age 8 for girls and before age 9 for boys.
                                                                           A hypermetabolic syndrome caused by the elevation of thyroid hormone levels in the serum. Signs and
                                                                           symptoms include tachycardia, palpitations, tremor, weight loss, warm weather intolerance, and moist
                                                                           skin. Causes include Graves disease, toxic nodular goiter, toxic thyroid nodule, and lymphocytic
Endocrine disorders                Thyrotoxicosis                          thyroiditis
Endocrine disorders                Virilization                            Masculinization; occurring inappropriately in a female or prepubertal male
                                                                           Blurred vision is the loss of visual acuity (sharpness of vision) resulting in a loss of ability to see small
Eye disorders                      Blurred vision                          details. (from MedlinePlus Medical Encyclopedia)
                                                                           Partial or complete opacity of the crystalline lens of one or both eyes that decreases visual acuity and
Eye disorders                      Cataract                                eventually results in blindness.
Eye disorders                      Conjunctivitis                          Inflammation of the conjunctiva of the eye.



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                                                                 Area of epithelial tissue loss from corneal surface; associated with inflammatory cells in the cornea and
Eye disorders                Corneal ulcer                       anterior chamber.
                                                                 A syndrome characterized by dryness of the cornea and conjunctiva. It is usually caused by a
                                                                 deficiency in tear production. Symptoms include a feeling of burning eyes and a possible foreign body
Eye disorders                Dry eye                             presence in the eye.
Eye disorders                Endophthalmitis                     An infectious process affecting the internal structures of the eye.
Eye disorders                Exophthalmos                        A protrusion of the eyeball from the socket.
Eye disorders                Extraocular muscle paresis          A slight or incomplete paralysis of an extraocular muscle.
Eye disorders                Eye pain                            Painful sensation in the eye.
Eye disorders                Eyelid function disorder            A disorder characterized by impaired eyelid function.
Eye disorders                Flashing lights                     A sudden or brief burst of light.
Eye disorders                Floaters                            Spots before the eyes caused by opaque cell fragments in the vitreous humor or lens.
Eye disorders                Glaucoma                            Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor.
Eye disorders                Keratitis                           Inflammation of the cornea.

Eye disorders                Night blindness                     An inability to see clearly in dim light; due to a deficiency of vitamin A or to a retinal disorder.
Eye disorders                Optic nerve disorder                A non-neoplastic or neoplastic disorder affecting the optic nerve (second cranial nerve).
                                                                 Swelling around the optic nerve, usually due to increased intracranial pressure or pressure on the
Eye disorders                Papilledema                         nerve by a tumor.
                                                                 Fear and avoidance of light. It can be the result of anxiety about the eyes, photosensitivity, or
Eye disorders                Photophobia                         photalgia.--2004

                                                                 An eye emergency condition which may lead to blindness if left untreated. It is characterized by the
Eye disorders                Retinal detachment                  separation of the inner retina layers from the underlying pigment epithelium.
                                                                 A usually small tearing of the retina occurring when the vitreous separates from the retina. It may lead
Eye disorders                Retinal tear                        to retinal detachment. Symptoms include flashes and floaters.
Eye disorders                Retinopathy                         Any disease or disorder of the retina.
Eye disorders                Scleral disorder                    A disorder affecting the sclera.
Eye disorders                Uveitis                             An inflammatory process affecting a part of or the entire uvea.
                                                                 Blood extravasation in the vitreous humor. Causes include neovascularization, retinal tear, retinal
Eye disorders                Vitreous hemorrhage                 detachment, and rupture of a blood vessel aneurysm in the eye.
Eye disorders                Watering eyes                       A condition caused either by tear overproduction or impaired drainage of the tear duct.
                                                                 Swelling of the abdomen resulting from excessive food intake, malnutrition, liver disease, primary
Gastrointestinal disorders   Abdominal distension                abdominal tumors, and tumors metastatic to the abdominal cavity.
Gastrointestinal disorders   Abdominal pain                      Painful sensation in the abdominal region.
Gastrointestinal disorders   Anal fistula                        A pathologic tract that connects an opening in the anal canal to the perianal skin.
Gastrointestinal disorders   Anal hemorrhage                     Bleeding originating from the anal area.
Gastrointestinal disorders   Anal mucositis                      An inflammatory process affecting the mucous membrane of the anus.
Gastrointestinal disorders   Anal necrosis                       A necrotic process involving the area of the anus.
Gastrointestinal disorders   Anal pain                           Painful sensation in the anal region.
Gastrointestinal disorders   Anal stenosis                       Narrowing of the anal canal.
Gastrointestinal disorders   Anal ulcer                          A painful tear in the lining of the anal canal, often accompanied by bleeding on defecation.
                                                                 Acute appendicitis with gangrenous changes resulting in the rupture of the appendiceal wall. The
                                                                 appendiceal wall rupture causes the release of inflammatory and bacterial contents from the
Gastrointestinal disorders   Appendicitis perforated             appendiceal lumen into the abdominal cavity.
                                                                 Accumulation of fluid in the peritoneal cavity. The fluid may be serous, hemorrhagic, or the result of
Gastrointestinal disorders   Ascites                             tumor metastasis to the peritoneum.
Gastrointestinal disorders   Bloating                            Distention of the abdomen associated with a feeling of fullness.
Gastrointestinal disorders   Cecal hemorrhage                    Bleeding originating in the cecum.
Gastrointestinal disorders   Cheilitis                           An inflammatory process affecting the lip.
Gastrointestinal disorders   Colitis                             Inflammation of the colon.




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Gastrointestinal disorders   Colonic fistula                        An abnormal communication between the large intestine and another organ or cavity.
Gastrointestinal disorders   Colonic hemorrhage                     Bleeding originating from the colon.
Gastrointestinal disorders   Colonic obstruction                    Blockage of the normal flow of the intestinal contents in the colon.
Gastrointestinal disorders   Colonic perforation                    A rupture in the colonic wall due to traumatic or pathologic processes.
Gastrointestinal disorders   Colonic stenosis                       Narrowing of the lumen of colon.

Gastrointestinal disorders   Colonic ulcer                          A circumscribed inflammatory and necrotic erosive lesion in the mucosa surface of the colon.
Gastrointestinal disorders   Constipation                           Irregular and infrequent or difficult evacuation of the bowels.
Gastrointestinal disorders   Diarrhea                               A condition of frequent and watery bowel movements.
Gastrointestinal disorders   Dry mouth                              An oral condition in which salivary flow is reduced.
Gastrointestinal disorders   Duodenal fistula                       An abnormal communication between the duodenum and another organ or cavity.
Gastrointestinal disorders   Duodenal hemorrhage                    Bleeding originating from the duodenum.
Gastrointestinal disorders   Duodenal obstruction                   Blockage of the normal flow of stomach contents through the duodenum.
Gastrointestinal disorders   Duodenal perforation                   A rupture in the duodenal wall due to traumatic or pathologic processes.
Gastrointestinal disorders   Duodenal stenosis                      Narrowing of the lumen of the duodenum.
Gastrointestinal disorders   Duodenal ulcer                         An ulcer in the duodenal wall.
                                                                    An uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms
Gastrointestinal disorders   Dyspepsia                              include burning stomach pain, bloating, heartburn, nausea, and vomiting.
                                                                    A symptom referring to difficulty in swallowing. It may be observed in patients with stroke, motor neuron
                                                                    disorders, cancer of the throat or mouth, head and neck injuries, Parkinson disease, and multiple
Gastrointestinal disorders   Dysphagia                              sclerosis.
Gastrointestinal disorders   Enteritis                              Inflammation of the intestine.
Gastrointestinal disorders   Enterocolitis                          An inflammatory process affecting the small and large intestines.
Gastrointestinal disorders   Enterovesical fistula                  An abnormal communication between the urinary bladder and the intestine.
Gastrointestinal disorders   Esophageal fistula                     An abnormal communication between the esophagus and another organ or anatomic site.
Gastrointestinal disorders   Esophageal hemorrhage                  Bleeding originating from the esophagus.
Gastrointestinal disorders   Esophageal mucositis                   An inflammatory process affecting the mucous membrane of the esophagus.
Gastrointestinal disorders   Esophageal necrosis                    A necrotic process involving the esophageal wall.
Gastrointestinal disorders   Esophageal obstruction                 Blockage of the normal flow of the contents in the esophagus.
Gastrointestinal disorders   Esophageal pain                        Painful sensation in the esophageal region.
                                                                    The presence of a hole or other type of opening in the esophageal wall through which the contents of
Gastrointestinal disorders   Esophageal perforation                 the esophagus can pass into the mediastinum.
Gastrointestinal disorders   Esophageal stenosis                    Narrowing of the lumen of the esophagus.
Gastrointestinal disorders   Esophageal ulcer                       An ulcerated lesion in the esophageal wall.
Gastrointestinal disorders   Esophageal varices hemorrhage          Bleeding from esophageal varices.
Gastrointestinal disorders   Esophagitis                            An acute or chronic inflammatory process affecting the esophageal wall.
Gastrointestinal disorders   Fecal incontinence                     Inability to control the escape of stool from the rectum.
Gastrointestinal disorders   Flatulence                             A state of excessive gas in the alimentary canal.
Gastrointestinal disorders   Gastric fistula                        An abnormal communication between the stomach and another organ or anatomic site.
Gastrointestinal disorders   Gastric hemorrhage                     Bleeding from the gastric wall.
Gastrointestinal disorders   Gastric mucositis                      An inflammatory process affecting the mucous membrane of the stomach.
Gastrointestinal disorders   Gastric necrosis                       A necrotic process affecting the gastric wall.
Gastrointestinal disorders   Gastric perforation                    A rupture in the gastric wall caused by traumatic or pathologic processes.
Gastrointestinal disorders   Gastric stenosis                       Narrowing of the lumen of the stomach.
                                                                    An ulcerated lesion in the mucosal surface of the stomach. It may progress to involve the deeper layers
Gastrointestinal disorders   Gastric ulcer                          of the gastric wall.
Gastrointestinal disorders   Gastritis                              Inflammation of the stomach.
                                                                    An abnormal communication between any part of the gastrointestinal system and another organ or
Gastrointestinal disorders   Gastrointestinal fistula               cavity.
Gastrointestinal disorders   Gastrointestinal pain                  Painful sensation in the gastrointestinal region.
Gastrointestinal disorders   Gingival pain                          Painful sensation in the gingival region.




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Gastrointestinal disorders   Hemorrhoidal hemorrhage                    Bleeding from the hemorrhoids.
Gastrointestinal disorders   Hemorrhoids                                Dilated veins in the rectum and anal area.
Gastrointestinal disorders   Ileal fistula                              An abnormal communication between the ileum and another organ or cavity.
Gastrointestinal disorders   Ileal hemorrhage                           Bleeding originating from the ileal wall.
Gastrointestinal disorders   Ileal obstruction                          Blockage of the normal flow of the small intestinal contents in the ileum.
Gastrointestinal disorders   Ileal perforation                          A rupture in the ileal wall due to traumatic or a pathologic processes.
Gastrointestinal disorders   Ileal stenosis                             Narrowing of the lumen of ileum.

Gastrointestinal disorders   Ileal ulcer                                A circumscribed inflammatory and necrotic erosive lesion in the mucosa surface of the ileum.
Gastrointestinal disorders   Ileus                                      An obstruction of the intestines, especially the ileum.
Gastrointestinal disorders   Intestinal necrosis                        A necrotic process involving the intestinal wall.
Gastrointestinal disorders   Intra-abdominal hemorrhage                 Bleeding within the abdominal cavity.
Gastrointestinal disorders   Jejunal fistula                            An abnormal communication between the jejunum and another organ or cavity.
Gastrointestinal disorders   Jejunal hemorrhage                         Bleeding originating from the jejunal wall.
Gastrointestinal disorders   Jejunal obstruction                        Blockage of the normal flow of the small intestinal contents in the jejunum.
Gastrointestinal disorders   Jejunal perforation                        A rupture in the jejunal wall due to traumatic or pathologic processes.
Gastrointestinal disorders   Jejunal stenosis                           Narrowing of the lumen of jejunum.

Gastrointestinal disorders   Jejunal ulcer                              A circumscribed inflammatory and necrotic erosive lesion in the mucosa surface of the jejunum.
Gastrointestinal disorders   Large intestinal mucositis                 An inflammatory process affecting the mucous membrane of the large intestine.
Gastrointestinal disorders   Lip pain                                   Painful sensation in the lip.
Gastrointestinal disorders   Lower gastrointestinal hemorrhage          Bleeding from the lower gastrointestinal tract (small intestine, large intestine, and anus).
                                                                        A syndrome resulting from the inadequate absorption of nutrients in the small intestine. Symptoms
Gastrointestinal disorders   Malabsorption                              include abdominal pain, bloating, and diarrhea.
Gastrointestinal disorders   Mouth necrosis                             A necrotic process affecting the tissues of the mouth.
Gastrointestinal disorders   Nausea                                     The sensation that one is about to vomit.
Gastrointestinal disorders   Obstruction gastric                        Blockage of the normal flow of the contents in the stomach.
Gastrointestinal disorders   Oral cavity fistula                        An abnormal communication between the oral cavity and the adjacent tissues.

Gastrointestinal disorders   Oral dysesthesia                           A condition characterized by a burning or tingling sensation on the lips, tongue, or entire mouth.
Gastrointestinal disorders   Oral hemorrhage                            Bleeding originating from the mouth.
Gastrointestinal disorders   Oral pain                                  Painful sensation in the mouth, tongue, or lips.
Gastrointestinal disorders   Pancreatic duct stenosis                   Narrowing of the lumen of the pancreatic duct.
Gastrointestinal disorders   Pancreatic fistula                         An abnormal communication between the pancreas and another organ or cavity.
Gastrointestinal disorders   Pancreatic hemorrhage                      Bleeding originating from the pancreas.
Gastrointestinal disorders   Pancreatic necrosis                        A necrotic process affecting the pancreas.
Gastrointestinal disorders   Pancreatitis                               Inflammation of the pancreas.
                                                                        An inflammatory process of the gingival tissues and/or periodontal membrane of the teeth, resulting in
                                                                        an abnormally deep gingival sulcus, possibly producing periodontal pockets and loss of alveolar bone
Gastrointestinal disorders   Periodontal disease                        support.
Gastrointestinal disorders   Peritoneal necrosis                        A necrotic process affecting the peritoneum.
Gastrointestinal disorders   Peritoneal pain                            Painful sensation in the peritoneum.
Gastrointestinal disorders   Proctitis                                  An inflammatory process affecting the rectum.
Gastrointestinal disorders   Rectal fistula                             An abnormal communication between the rectum and another organ or cavity.
Gastrointestinal disorders   Rectal hemorrhage                          Bleeding originating from the rectal wall and discharged from the anus.
Gastrointestinal disorders   Rectal mucositis                           An inflammatory process affecting the mucous membrane of the rectum.
Gastrointestinal disorders   Rectal necrosis                            A necrotic process involving the rectal wall.
Gastrointestinal disorders   Rectal obstruction                         Blockage of the normal flow of the intestinal contents in the rectum.
Gastrointestinal disorders   Rectal pain                                Pain in the rectal area.
Gastrointestinal disorders   Rectal perforation                         An rupture in the rectal wall due to traumatic or pathologic processes.
Gastrointestinal disorders   Rectal stenosis                            Narrowing of the rectal lumen.




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Gastrointestinal disorders       Rectal ulcer                               A circumscribed inflammatory and necrotic erosive lesion in the mucosa surface of the rectum.
Gastrointestinal disorders       Retroperitoneal hemorrhage                 Bleeding originating in the retroperitoneal area.
Gastrointestinal disorders       Salivary duct inflammation                 An inflammatory process affecting the salivary duct.
Gastrointestinal disorders       Salivary gland fistula                     An abnormal communication between a salivary gland and another organ or anatomic site.
Gastrointestinal disorders       Small intestinal mucositis                 An inflammatory process affecting the mucous membrane of the small intestine.
Gastrointestinal disorders       Small intestinal necrosis                  A necrotic process involving the wall of the small intestine.
Gastrointestinal disorders       Small intestinal obstruction               Blockage of the normal flow of the small intestinal contents.
Gastrointestinal disorders       Small intestinal perforation               A rupture in the wall of the small intestine due to traumatic or pathologic processes.
Gastrointestinal disorders       Small intestinal stenosis                  Narrowing of the lumen of small intestine.

Gastrointestinal disorders       Small intestine ulcer                      A circumscribed inflammatory and necrotic erosive lesion in the mucosa surface of the small intestine.
Gastrointestinal disorders       Stomach pain                               A painful sensation in the stomach.
Gastrointestinal disorders       Stomatitis                                 Inflammation of the oral mucosa due to local or systemic factors.
Gastrointestinal disorders       Tooth development disorder                 A disorder of the teeth arising during odontogenesis.
                                                                            A change in tooth color. Causes may be local or systemic and include tobacco use, foods, dental
                                                                            plaques, caries, restorative filling materials, trauma, medications, infections, hereditary diseases, and
Gastrointestinal disorders       Tooth discoloration                        nutritional deficiencies.
Gastrointestinal disorders       Tooth disorder                             A non-neoplastic or neoplastic (benign or malignant) disorder affecting the teeth.
Gastrointestinal disorders       Toothache                                  A painful sensation originating from a tooth.
Gastrointestinal disorders       Typhlitis                                  Inflammation of the cecum.
                                                                            Bleeding originating from the upper gastrointestinal tract (oral cavity, pharynx, esophagus, and
Gastrointestinal disorders       Upper gastrointestinal hemorrhage          stomach).
Gastrointestinal disorders       Vomiting                                   The reflex act of ejecting the contents of the stomach through the mouth.
General disorders and
administration site conditions   Asthenia                                   A sign or symptom of weakness and diminished or absent energy and strength.
General disorders and
administration site conditions   Chills                                     A sensation of cold that often marks the start of an infection and the development of a fever.
General disorders and
administration site conditions   Death                                      The cessation of life.
General disorders and
administration site conditions   Death neonatal                             Cessation of life occuring during the first 28 days of life.
General disorders and
administration site conditions   Edema limbs                                Swelling due to an excessive accumulation of fluid in the upper or lower extremities.
General disorders and
administration site conditions   Edema trunk                                Swelling due to an excessive accumulation of fluid in trunk area.
General disorders and
administration site conditions   Face edema                                 Swelling due to an excessive accumulation of fluid in facial tissues.
General disorders and
administration site conditions   Facial pain                                Painful sensation in the face.
                                                                            A state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish
                                                                            daily activities. That state, following a period of mental or bodily activity, characterized by a lessened
General disorders and                                                       capacity for work and reduced efficiency of accomplishment, usually accompanied by a feeling of
administration site conditions   Fatigue                                    weariness, sleepiness, or irritability.
General disorders and                                                       The elevation of the body's temperature above the upper limit of normal, usually taken as 37.7 degrees
administration site conditions   Fever                                      C.
General disorders and                                                       A group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body
administration site conditions   Flu like symptoms                          aches, malaise, loss of appetite, and dry cough.
General disorders and
administration site conditions   Gait disturbance                           Walking difficulties.




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                                                                      An abnormally low body temperature. Treatment is required when the body temperature is 35C (95F)
General disorders and                                                 or below. Symptoms include decreased mental function, lethargy, and disorientation. Abnormally low
administration site conditions   Hypothermia                          body temperature.
                                                                      A reaction to the infusion of pharmacological or biological substances. Symptoms may appear within
General disorders and                                                 minutes to hours following the infusion and may include pruritus, flushing, swelling, dyspnea,
administration site conditions   Infusion related reaction            bronchospasm, and hypotension.

General disorders and                                                 Leakage of a pharmacologic substance from the infusion site into the surrounding tissue. Signs and
administration site conditions   Infusion site extravasation          symptoms include induration, erythema, swelling, burning sensation, and pain at the infusion site.
General disorders and
administration site conditions   Injection site reaction              An intense reaction (usually immunologic) developing at the site of injection
General disorders and                                                 An abnormal responsiveness or morbid excitability of an organ, its part, or entire organism or its part to
administration site conditions   Irritability                         stimuli.
General disorders and
administration site conditions   Localized edema                      Swelling due to an excessive accumulation of fluid at a specific anatomic site.
General disorders and
administration site conditions   Malaise                              A feeling of general discomfort or uneasiness, an out-of-sorts feeling.
General disorders and                                                 A progressive condition usually characterized by combined failure of the lungs, liver, kidney, and
administration site conditions   Multi-organ failure                  clotting mechanisms.
General disorders and
administration site conditions   Neck edema                           Swelling due to an accumulation of excessive fluid in the neck.
General disorders and
administration site conditions   Non-cardiac chest pain               Pain in the chest unrelated to a heart disorder.
General disorders and                                                 The sensation of discomfort, distress, or agony, resulting from the stimulation of specialized nerve
administration site conditions   Pain                                 endings.

                                                                      Swelling due to excessive accumulation of fluid under the skin defined by a persistent indentation when
General disorders and                                                 pressure is applied to the swollen area. Causes include systemic conditions (e.g., heart failure, liver
administration site conditions   Pitting edema                        failure, or kidney failure) and local conditions affecting the extremities.
General disorders and
administration site conditions   Thrombus in catheter                 The development of a blood clot in a catheter.
Hepatobiliary disorders          Bile duct stenosis                   Narrowing or stricture of the bile duct.
Hepatobiliary disorders          Biliary fistula                      An abnormal communication between the bile ducts and another organ or cavity.
                                                                      An acute or chronic inflammation involving the gallbladder wall. It may be associated with the presence
Hepatobiliary disorders          Cholecystitis                        of gallstones.
Hepatobiliary disorders          Gallbladder fistula                  An abnormal communication between the gallbladder and another organ or cavity.
Hepatobiliary disorders          Gallbladder necrosis                 A necrotic process occurring in the gallbladder.
Hepatobiliary disorders          Gallbladder obstruction              Blockage of the normal flow of the contents of the gallbladder.
Hepatobiliary disorders          Gallbladder pain                     Painful sensation in the gallbladder region.
Hepatobiliary disorders          Gallbladder perforation              A rupture in the gallbladder wall caused by traumatic or pathologic processes.
Hepatobiliary disorders          Hepatic hemorrhage                   Bleeding originating from the liver.
Hepatobiliary disorders          Hepatic necrosis                     A necrotic process affecting the hepatic parenchyma.
Hepatobiliary disorders          Hepatic pain                         A painful sensation in the liver.
Hepatobiliary disorders          Hyperbilirubinemia                   Abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice.
                                                                      A rupture in the wall of the extrahepatic or intrahepatic bile duct due to traumatic or pathologic
Hepatobiliary disorders          Perforation bile duct                processes.
Hepatobiliary disorders          Portal hypertension                  Increased blood pressure in the portal venous system.
Hepatobiliary disorders          Portal vein thrombosis               The formation of a blood clot (thrombus) in the portal vein.
                                                                      A local or general reaction of an organism following contact with a specific allergen to which it has been
Immune system disorders          Allergic reaction                    previously exposed and to which it has become sensitized.




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                                                                     An acute inflammatory reaction resulting from the release of histamine and histamine-like substances
                                                                     from mast cells, causing a hypersensitivity immune response. Clinically, it presents with breathing
Immune system disorders       Anaphylaxis                            difficulty, dizziness, hypotension, cyanosis and loss
                                                                     A disorder resulting from loss of function or tissue destruction of an organ or multiple organs, arising
                                                                     from humoral or cellular immune responses of the individual to his own tissue constituents. It may be
Immune system disorders       Autoimmune disorder                    systemic or localized.
                                                                     A syndrome that occurs after therapeutic infusion of antibodies into the blood and is characterized by
                                                                     nausea, headache, tachycardia, hypotension, rash, and shortness of breath. It is caused by the release
Immune system disorders       Cytokine release syndrome              of cytokines from the cells.

                                                                     Delayed-type hypersensitivity reaction to foreign proteins derived from an animal serum. It occurs
                                                                     approximately six to twenty one days following the administration of the foreign antigen. Symptoms
Immune system disorders       Serum sickness                         include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest pain, and dyspnea.
                                                                     Infection in the abdominal cavity resulting from injury, acute intestinal inflammation (e.g., acute
Infections and infestations   Abdominal infection                    appendicitis), intestinal perforation, or complication of abdominal surgery.
Infections and infestations   Anal infection                         An infectious process affecting the anal area.
Infections and infestations   Anorectal infection                    An infectious process affecting the anal area and the rectum.
Infections and infestations   Appendicitis                           Acute inflammation of the vermiform appendix.
Infections and infestations   Arteritis infective                    An infectious process affecting an artery.
Infections and infestations   Biliary tract infection                An acute or chronic inflammatory process affecting the biliary tract.
Infections and infestations   Bladder infection                      An acute or chronic inflammatory process affecting the bladder.
Infections and infestations   Bone infection                         An acute or chronic infectious process affecting the bones.
Infections and infestations   Breast infection                       An infectious process affecting the breast.
Infections and infestations   Bronchial infection                    An acute or chronic inflammatory process affecting the bronchi.
Infections and infestations   Catheter related infection             An infection that arises secondary to catheter use.
Infections and infestations   Cecal infection                        An infectious process affecting the cecum.
Infections and infestations   Conjunctivitis infective               Acute inflammation of the conjunctiva characterized by pink or red color in the eyes.
Infections and infestations   Corneal infection                      Inflammation of the cornea.
Infections and infestations   Cranial nerve infection                An infectious process affecting a cranial nerve.
Infections and infestations   Device related infection               An infectious disorder caused by the use of a medical device.
Infections and infestations   Duodenal infection                     An infectious process affecting the duodenum.
Infections and infestations   Encephalitis infection                 An acute infectious process that affects the brain tissue.
Infections and infestations   Encephalomyelitis infection            An infectious process that affects the brain and spinal cord tissues.
Infections and infestations   Endocarditis infective                 An infectious process involving the endocardial layer of the heart.
Infections and infestations   Esophageal infection                   An infectious process affecting the esophagus.
Infections and infestations   Eye infection                          An infectious process affecting any part of the eye.
Infections and infestations   Gallbladder infection                  An acute or chronic infectious process affecting the gallbladder.
Infections and infestations   Genitourinary tract infection          An acute or chronic infectious process affecting any part of the genitourinary system.
Infections and infestations   Gum infection                          An acute or chronic infectious process affecting the gums.
Infections and infestations   Hepatic infection                      An acute or chronic infectious process affecting the liver.
Infections and infestations   Hepatitis viral                        An acute or chronic inflammation of the liver parenchyma caused by viruses.
Infections and infestations   Implant infection                      An infectious process involving an implanted medical device and the surrounding tissues.
Infections and infestations   Infectious colitis                     A viral or bacterial infectious process affecting the large intestine.
                                                                     Inflammation of the meninges of the brain and/or spinal cord caused by an infectious agent (viral,
                                                                     bacterial, or fungal). Symptoms include headache, fever, vomiting, neck stiffness, photophobia,
Infections and infestations   Infectious meningitis                  confusion, and seizures.
Infections and infestations   Infective cervicitis                   An infectious process affecting the uterine cervix.

                                                                     An infectious process affecting the skeletal muscles. It can be caused by viruses (including HIV),
Infections and infestations   Infective myositis                     bacteria, fungi, and parasites. Symptoms include muscle weakness and muscle pain.




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Infections and infestations   Joint infection                     An infectious process affecting a joint. Causative agents include bacteria, viruses, fungi, and parasites.
                                                                  An acute or chronic inflammatory process affecting the kidney. It is the result of a urinary tract infection.
                                                                  Signs and symptoms include fever, chills, flank pain, painful and frequent urination, cloudy or bloody
Infections and infestations   Kidney infection                    urine, and confusion.
                                                                  An acute or chronic, bacterial or viral inflammatory process affecting the larynx. Symptoms include sore
Infections and infestations   Laryngitis                          throat, cough, swallowing difficulties, and hoarseness.
Infections and infestations   Lip infection                       An acute or chronic infectious process affecting the lips.
Infections and infestations   Lung infection                      An acute or chronic infectious process affecting the lungs.
Infections and infestations   Lymph gland infection               An acute or chronic infectious process affecting the lymph nodes.
Infections and infestations   Mediastinal infection               An acute or chronic infectious process of the mediastinum.
Infections and infestations   Mucosal infection                   An acute or chronic infectious process affecting a mucosal surface.
Infections and infestations   Nail infection                      An infectious process affecting the nail.
                                                                  A bacterial infectious process involving the outer ear and ear canal. Contributory factors include
                                                                  excessive water exposure (swimmer's ear infection) and cuts in the ear canal. Symptoms include
Infections and infestations   Otitis externa                      fullness, itching, swelling and pain in the ear and ear drainage.
Infections and infestations   Otitis media                        An acute or chronic inflammatory process affecting the middle ear.
Infections and infestations   Ovarian infection                   An infectious process affecting the ovary.
Infections and infestations   Pancreas infection                  An infectious process affecting the pancreas.

Infections and infestations   Paranasal sinus infection           An acute or chronic infectious process affecting the mucous membranes of the paranasal sinuses.
                                                                  An acute or chronic infection of the soft tissues around the nail. Symptoms include pain, tenderness,
                                                                  erythema, and swelling around the nail. Acute infection results from minor trauma to the fingertip and
                                                                  Staphylococcus aureus is usually the causative agent. Chronic infection is usually caused by Candida
Infections and infestations   Paronychia                          albicans.
                                                                  Pelvic inflammatory disease (PID) is an acute or chronic inflammation in the pelvic cavity. PID may be
Infections and infestations   Pelvic infection                    either symptomatic or asymptomatic.
Infections and infestations   Penile infection                    An infectious process affecting the penis.
Infections and infestations   Periorbital infection               An infectious process affecting the tissues around the orbit.
Infections and infestations   Peripheral nerve infection          An infectious process affecting the peripheral nerves.
Infections and infestations   Peritoneal infection                An infectious process affecting the peritoneum.
                                                                  Inflammation of the throat most often caused by viral and bacterial infections. Other causes include
Infections and infestations   Pharyngitis                         allergens, chemical substances, and trauma.

                                                                  Infection at the site of needle puncture or intravenous catheter placement due to poor aseptic
Infections and infestations   Phlebitis infective                 techniques. It is characterized by erythema, pain, swelling, and induration at the catheter insertion site.
Infections and infestations   Pleural infection                   An infectious process affecting the pleura.
Infections and infestations   Prostate infection                  An acute or chronic infectious process affecting the prostate gland.
Infections and infestations   Rash pustular                       A circumscribed and elevated skin lesion filled with pus.
                                                                  An inflammatory process affecting the nasal mucosa. It is characterized by chills, headaches,
Infections and infestations   Rhinitis infective                  mucopurulent nasal discharge, coughing, and facial pain.
                                                                  A viral (such as mumps) or bacterial infectious process affecting the salivary gland. The salivary gland
Infections and infestations   Salivary gland infection            become enlarged and is often painful.
Infections and infestations   Scrotal infection                   A bacterial, fungal or viral infectious process affecting the scrotum.

                                                                  The presence of pathogenic microorganisms in the blood stream causing a rapidly progressing
                                                                  systemic reaction that may lead to shock. Symptoms include fever, chills, tachycardia, and increased
Infections and infestations   Sepsis                              respiratory rate. It is a medical emergency that requires urgent medical attention.

Infections and infestations   Sinusitis                           An acute or chronic infectious process affecting the mucous membranes of the paranasal sinuses.




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Infections and infestations        Skin infection                           An inflammatory process affecting the skin, caused by bacteria, viruses, parasites, or fungi.
Infections and infestations        Small intestine infection                An infectious process affecting the small intestine.
                                                                            A bacterial infectious process affecting the soft tissues. A severe form caused by anaerobic or aerobic
                                                                            bacteria is associated with soft tissues necrosis and affects the subcutaneous adipose tissue, muscles,
Infections and infestations        Soft tissue infection                    fascia, and the skin.
                                                                            An infectious process affecting the spleen. Predisposing factors include immunosuppression, diabetes
                                                                            mellitus, and sickle cell anemia. Infectious agents include bacteria (e.g., staphylococcus and
Infections and infestations        Splenic infection                        streptococcus) and fungi.
Infections and infestations        Stoma site infection                     An infectious process affecting a surgically created opening in the surface of the body.
Infections and infestations        Tooth infection                          An infectious process affecting a tooth.

Infections and infestations        Tracheitis                               Bacterial infectious process with formation of mucopurulent membranes affecting the trachea.

                                                                            An infectious process affecting the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or
Infections and infestations        Upper respiratory infection              trachea). Symptoms include congestion, sneezing, coughing, fever, and sore throat.
Infections and infestations        Urethral infection                       A bacterial, viral, or fungal infectious process affecting the urethra.
                                                                            A bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and
                                                                            the urethra. Symptoms include urinary urgency and frequency, burning sensation during urination,
Infections and infestations        Urinary tract infection                  lower abdominal discomfort, and cloudy urine.
                                                                            An acute or chronic, usually bacterial infectious process affecting the endometrium. It may extend to
                                                                            the myometrium and parametrial tissues. Symptoms include lower abdominal pain, vaginal discharge,
Infections and infestations        Uterine infection                        and vaginal bleeding.

Infections and infestations        Vaginal infection                        An infectious process affecting the vagina. Symptoms include pain and purulent discharge.
Infections and infestations        Vascular implant infection               An infectious process originating from an implanted vascular device.
Infections and infestations        Vulval infection                         An infectious process affecting the vulva.
Infections and infestations        Wound infection                          Infection occurring in the wound.
Injury, poisoning and procedural
complications                      Aortic injury                            Damage to the aorta from traumatic or pathologic processes.
Injury, poisoning and procedural
complications                      Arterial injury                          Damage to an artery from traumatic or pathologic processes.
Injury, poisoning and procedural
complications                      Biliary anastomotic leak                 Leakage of bile due to breakdown of a biliary anastomosis.
Injury, poisoning and procedural
complications                      Bladder anastomotic leak                 Leakage of urine due to breakdown of a bladder anastomosis.
Injury, poisoning and procedural
complications                      Bruising                                 Injury of the soft tissues or bone without breaking the skin, as by a blow. (from Dictionary.com)
Injury, poisoning and procedural
complications                      Chemical Burn                            A burn caused by exposure to chemical substances.
Injury, poisoning and procedural                                            A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of
complications                      Dermatitis radiation                     ionizing radiation.
Injury, poisoning and procedural
complications                      Device complication                      Problems arising from the use of a medical device.
Injury, poisoning and procedural
complications                      Esophageal anastomotic leak              Leakage due to breakdown of an esophageal anastomosis.
Injury, poisoning and procedural
complications                      Fall                                     A sudden movement downward, usually resulting in injury.
Injury, poisoning and procedural
complications                      Fallopian tube anastomotic leak          Leakage due to breakdown of a fallopian tube anastomosis.




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Injury, poisoning and procedural
complications                      Fracture                                          A traumatic or pathologic injury to the bone in which the continuity of the bone is broken.
Injury, poisoning and procedural
complications                      Gastric anastomotic leak                          Leakage due to breakdown of a gastric anastomosis.
Injury, poisoning and procedural
complications                      Gastrointestinal anastomotic leak                 Leakage due to breakdown of a gastrointestinal anastomosis.
Injury, poisoning and procedural
complications                      Gastrointestinal stoma necrosis                   A necrotic process affecting the post-operative stoma area in the gastrointestinal tract.
Injury, poisoning and procedural
complications                      Injury to carotid artery                          Damage to the carotid artery.
Injury, poisoning and procedural
complications                      Injury to inferior vena cava                      Damage to the inferior vena cava from traumatic or pathologic processes.
Injury, poisoning and procedural
complications                      Injury to jugular vein                            Damage to the jugular vein from traumatic or pathologic processes.
Injury, poisoning and procedural
complications                      Injury to superior vena cava                      Damage to the superior vena cava from traumatic or pathologic processes.
Injury, poisoning and procedural
complications                      Intestinal stoma leak                             Leakage of contents from the intestinal stoma.
Injury, poisoning and procedural                                                     A blockage of the intestinal stoma.
complications                      Intestinal stoma obstruction
Injury, poisoning and procedural
complications                      Intestinal stoma site bleeding                    Bleeding originating from the intestinal stoma.
Injury, poisoning and procedural
complications                      Intraoperative arterial injury                    Damage to an artery during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative breast injury                      Damage to the breast parenchyma during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative cardiac injury                     Damage to the heart during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative ear injury                         Damage to the ear during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative endocrine injury                   Damage to an endocrine gland during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative gastrointestinal injury            Damage to any part of the gastrointestinal system during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative head and neck injury               Damage to head and neck during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative hemorrhage                         Uncontrolled bleeding during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative hepatobiliary injury               Damage to the hepatic parenchyma and biliary tract during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative musculoskeletal injury             Damage to any part of the musculoskeletal system during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative neurological injury                Damage to any part of the nervous system during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative ocular injury                      Damage to the eye during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative renal injury                       Damage to the kidney during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative reproductive tract injury          Damage to the reproductive organs during a surgical procedure.




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Injury, poisoning and procedural
complications                      Intraoperative respiratory injury               Damage to the respiratory system during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative skin injury                      Damage to the skin during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative splenic injury                   Damage to the spleen during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative urinary injury                   Damage to any part of the urinary system during a surgical procedure.
Injury, poisoning and procedural
complications                      Intraoperative venous injury                    Damage to a vein during a surgical procedure.
Injury, poisoning and procedural
complications                      Kidney anastomotic leak                         Leakage of urine due to breakdown of a kidney anastomosis.
Injury, poisoning and procedural
complications                      Large intestinal anastomotic leak               Leakage due to breakdown of a large intestinal anastomosis.
Injury, poisoning and procedural
complications                      Pancreatic anastomotic leak                     Leakage due to breakdown of a pancreatic anastomosis.
Injury, poisoning and procedural
complications                      Pharyngeal anastomotic leak                     Leakage due to breakdown of a pharyngeal anastomosis.
Injury, poisoning and procedural                                                   Bleeding occurring after completion of a surgical procedure. Postoperative bleeding may follow surgery
complications                      Postoperative hemorrhage                        immediately or may be delayed; it may be wound-related or not.
Injury, poisoning and procedural
complications                      Postoperative thoracic procedure complication   Any disorder occurring postoperatively as a consequence of a thoracic procedure.
Injury, poisoning and procedural
complications                      Prolapse of intestinal stoma                    An intestinal stoma complication characterized by protrusion of the stoma above the abdominal surface.
Injury, poisoning and procedural
complications                      Prolapse of urostomy                            Displacement of the urostomy.

                                                                                   Acute skin inflammatory reaction caused by drugs, especially chemotherapeutic agents, weeks or
Injury, poisoning and procedural                                                   months following radiotherapy. The inflammatory reaction is confined to the previously irradiated skin
complications                      Radiation recall reaction (dermatologic)        and the symptoms disappear after the removal of the pharmaceutical agent.
Injury, poisoning and procedural
complications                      Rectal anastomotic leak                         Leakage due to breakdown of a rectal anastomosis.
Injury, poisoning and procedural
complications                      Seroma                                          A tumor-like collection of serum in the tissues.
Injury, poisoning and procedural
complications                      Small intestinal anastomotic leak               Leakage due to breakdown of a small intestinal anastomosis.
Injury, poisoning and procedural
complications                      Spermatic cord anastomotic leak                 Leakage due to breakdown of a spermatic cord anastomosis.
Injury, poisoning and procedural
complications                      Stenosis of gastrointestinal stoma              Narrowing of the lumen of a gastrointestinal stoma.
Injury, poisoning and procedural                                                   An ulcer that develops in the jejunal mucosa close to the anastomosis site following a
complications                      Stomal ulcer                                    gastroenterostomy procedure.
Injury, poisoning and procedural
complications                      Thermal burn                                    A burn injury caused by heat or fire.
Injury, poisoning and procedural
complications                      Tracheal hemorrhage                             Bleeding originating from the trachea.
Injury, poisoning and procedural
complications                      Tracheal obstruction                            Blockage of the lumen of the trachea. Causes include secretions, foreign bodies, and tumors.
Injury, poisoning and procedural
complications                      Tracheostomy site bleeding                      Bleeding from the tracheostomy site.




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Injury, poisoning and procedural
complications                      Ureteric anastomotic leak                           Leakage due to breakdown of a ureteral anastomosis.
Injury, poisoning and procedural
complications                      Urethral anastomotic leak                           Leakage due to breakdown of a urethral anastomosis.
Injury, poisoning and procedural
complications                      Urostomy leak                                       Leakage of contents from a urostomy.
Injury, poisoning and procedural
complications                      Urostomy obstruction                                Blockage of the urostomy.
Injury, poisoning and procedural
complications                      Urostomy site bleeding                              Hemorrhage from the urostomy site.
Injury, poisoning and procedural
complications                      Urostomy stenosis                                   Narrowing of the opening of a urostomy.
Injury, poisoning and procedural
complications                      Uterine anastomotic leak                            Leakage due to breakdown of a uterine anastomosis.
Injury, poisoning and procedural
complications                      Vaginal anastomotic leak                            Leakage due to breakdown of a vaginal anastomosis.
Injury, poisoning and procedural
complications                      Vas deferens anastomotic leak                       Leakage due to breakdown of a vas deferens anastomosis.
                                                                                       Complications related to damage at the vascular access site. Examples include bleeding, formation of
Injury, poisoning and procedural                                                       hematoma, aneurysm, pseudoaneurysm, or arteriovenous fistula, development of infection, and
complications                      Vascular access complication                        catheter thrombosis.
Injury, poisoning and procedural
complications                      Venous injury                                   Damage to a vein from traumatic or pathologic processes.
Injury, poisoning and procedural                                                   A medical condition that develops at the site of an existing wound. Examples include swelling, draining,
complications                      Wound complication                              bleeding, formation of hematoma, infection, and necrosis.
Injury, poisoning and procedural                                                   Splitting of the sutured margins of a surgical wound. Risk factors include diabetes mellitus, obesity, and
complications                      Wound dehiscence                                advanced age.
                                                                                   An abnormal laboratory test result in which the partial thromboplastin time is found to be greater than
Investigations                     Activated partial thromboplastin time prolonged the control value.
Investigations                     Alanine aminotransferase increased              An increase in the level of alanine aminotransferase in the blood.
                                                                                   A laboratory test result which indicates an increased level of alkaline phosphatase in a biological
Investigations                     Alkaline phosphatase increased                  specimen.
Investigations                     Aspartate aminotransferase increased            An increase in the level of aspartate aminotransferase in the blood.

Investigations                     Blood antidiuretic hormone abnormal                 A laboratory test result which indicates abnormal levels of antidiuretic hormone in the blood.
Investigations                     Blood corticotrophin decreased                      A laboratory test result which indicates decreased levels of corticotrophin in the blood.

Investigations                     Blood gonadotrophin abnormal                        A laboratory test result which indicates abnormal levels of gonadotrophin hormone in the blood.
Investigations                     Blood prolactin abnormal                            A laboratory test result which indicates abnormal levels of prolactin hormone in the blood.
Investigations                     Body height below normal                            Body height below the normal range.

Investigations                     Carbon monoxide diffusing capacity decreased A lung function test result in which the lung capacity to absorb carbon monoxide is decreased.

Investigations                     Cardiac troponin increased                          A laboratory test result which indicates increased levels of cardiac troponin I in a biological specimen.

Investigations                     CD4 lymphocytes decreased                           A laboratory test result which indicates decreased levels of CD4 lymphocytes in a biospecimen.
                                                                                       Gradual and usually permanent loss of kidney function resulting in renal failure. Causes include
Investigations                     Chronic kidney disease                              diabetes, hypertension, and glomerulonephritis.
                                                                                       A laboratory test result which indicates increased levels of creatine phosphokinase in a biological
Investigations                     CPK increased                                       specimen.




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Investigations                       Creatinine increased                         A laboratory test result which indicates increased levels of creatinine in a biological specimen.
                                     Electrocardiogram QT corrected interval
Investigations                       prolonged                                    A QT interval that is prolonged. The length of the QT interval varies with the heart rate.

Investigations                       Fibrinogen decreased                         A laboratory test result which indicates decreased levels of fibrinogen in a biological specimen.

Investigations                       Forced expiratory volume decreased           A decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.
                                                                                  Increase in the level of the enzyme gamma-glutamyltransferase in the blood, which catalyzes the
                                                                                  transfer of a gamma glutamyl group from a gamma glutamyl peptide to another peptide, aminoacids, or
Investigations                       GGT increased                                water.

Investigations                       Growth hormone abnormal                      A laboratory test result which indicates abnormal levels of growth hormone in a biologic specimen.

Investigations                       Haptoglobin decreased                        A laboratory test result which indicates decreased levels of haptoglobin in a biological specimen.

Investigations                       Hemoglobin increased                         A laboratory test result which indicates increased levels of hemoglobin in a biological specimen.
                                                                                  A laboratory test result which indicates increased levels of INR (International Normalized Ratio) in the
Investigations                       INR Increased                                blood.
Investigations                       Lipase increased                             A laboratory test result which indicates increased levels of lipase in a biologic specimen.

Investigations                       Pancreatic enzymes decreased                 A laboratory test result which indicates decreased levels of pancreatic enzymes in a biologic specimen.
Investigations                       Serum amylase increased                      A laboratory test indicating increased levels of amylase in the serum.
                                                                                  A pulmonary function test result indicating an abnormal vital capacity as compared to the predicted
Investigations                       Vital capacity abnormal                      value.
Investigations                       Weight gain                                  An increase in overall body mass.
Investigations                       Weight loss                                  A reduction in overall body mass.

Metabolism and nutrition disorders   Acidosis                                     An abnormally high acidity (excess hydrogen-ion concentration) of the blood and other body tissues.
                                                                                  Increased sensitivity to the adverse effects of alcohol, which can include nasal congestion, skin
Metabolism and nutrition disorders   Alcohol intolerance                          flushes, heart dysrhmthias, nausea, vomiting, indigestion and headaches.

Metabolism and nutrition disorders   Alkalosis                                    An abnormally high alkalinity (low hydrogen-ion concentration) of the blood and other body tissues.

Metabolism and nutrition disorders   Anorexia                                     Lack or loss of appetite; aversion to food
                                                                                  A condition resulting from the excessive loss of water from the body. It is usually caused by severe
Metabolism and nutrition disorders   Dehydration                                  diarrhea, vomiting or diaphoresis.

Metabolism and nutrition disorders   Glucose intolerance                          Inability to properly metabolize glucose

Metabolism and nutrition disorders   Hypercalcemia                                Abnormally high concentration of calcium in the peripheral blood.

Metabolism and nutrition disorders   Hypercholesteremia                           A laboratory test result indicating an increased amount of cholesterol in the blood.

Metabolism and nutrition disorders   Hyperglycemia                                A high level of blood sugar. It is usually an indication of diabetes mellitus or glucose intolerance.
                                                                                  Higher than normal levels of potassium in the circulating blood; associated with kidney failure or
Metabolism and nutrition disorders   Hyperkalemia                                 sometimes with the use of diuretic drugs.

Metabolism and nutrition disorders   Hypermagnesemia                              Higher than normal levels of magnesium in the circulating blood.

Metabolism and nutrition disorders   Hypernatremia                                Higher than normal levels of sodium in the circulating blood.



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                                                                              Higher than normal levels of potassium in the circulating blood; associated with kidney failure or
Metabolism and nutrition disorders   Hypertriglyceridemia                     sometimes with the use of diuretic drugs.

Metabolism and nutrition disorders   Hyperuricemia                            Elevated blood concentrations of uric acid.

Metabolism and nutrition disorders   Hypoalbuminemia                          Abnormally low levels of albumin in the blood

Metabolism and nutrition disorders   Hypocalcemia                             Lower than normal levels of calcium in the circulating blood.

Metabolism and nutrition disorders   Hypoglycemia                             Abnormally low level of glucose in the blood.

Metabolism and nutrition disorders   Hypokalemia                              Lower than normal levels of potassium in the circulating blood.

Metabolism and nutrition disorders   Hypomagnesemia                           Lower than normal levels of magnesium in the circulating blood.

Metabolism and nutrition disorders   Hyponatremia                             Lower than normal levels of sodium in the circulating blood.

Metabolism and nutrition disorders   Hypophosphatemia                         Lower than normal levels of phosphates in the circulating blood.
                                                                              Accumulation of iron in the tissues. It may be a manifestation of an inherited disorder (e.g.,
                                                                              hemochromatosis) or acquired (in patients with repeated blood transfusions). Symptoms include
Metabolism and nutrition disorders   Iron overload                            hepatomegaly, arthritis, diabetes mellitus, and bronzed skin.

Metabolism and nutrition disorders   Obesity                                  Having a high amount of body fat (body mass index [BMI] of 30 or more).
Musculoskeletal and connective
tissue disorders                     Abdominal soft tissue necrosis           A necrotic process occurring in the soft tissues of the abdominal wall.
Musculoskeletal and connective
tissue disorders                     Arthralgia                               Pain in a joint.
Musculoskeletal and connective
tissue disorders                     Arthritis                                An inflammatory process affecting a joint.
                                                                              Necrotic changes in the bone tissue due to interruption of blood supply. Most often affecting the
Musculoskeletal and connective                                                epiphysis of the long bones, the necrotic changes result in the collapse and the destruction of the bone
tissue disorders                     Avascular necrosis                       structure.
Musculoskeletal and connective
tissue disorders                     Back pain                                Painful sensation in the back region.
Musculoskeletal and connective
tissue disorders                     Bone pain                                Painful sensation in the bones.
Musculoskeletal and connective
tissue disorders                     Buttock Pain                             Painful sensation in the buttocks.
Musculoskeletal and connective
tissue disorders                     Chest wall pain                          Painful sensation in the chest wall region.
Musculoskeletal and connective
tissue disorders                     Exostosis                                Non-neoplastic overgrowth of bone.
Musculoskeletal and connective
tissue disorders                     Fibrosis deep connective tissue          Fibrotic degeneration of the deep connective tissues.
Musculoskeletal and connective
tissue disorders                     Flank pain                               Painful sensation in the region below the ribs and above the hip.
Musculoskeletal and connective
tissue disorders                     Generalized muscle weakness              A reduction in the strength of muscles in multiple anatomic sites.
Musculoskeletal and connective
tissue disorders                     Growth suppression                       Stature that is smaller than normal as expected for age.




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Musculoskeletal and connective
tissue disorders                 Head soft tissue necrosis                        A necrotic process affecting the soft tissues of the head.
Musculoskeletal and connective
tissue disorders                 Joint effusion                                   Abnormally increased amount of fluid in a joint cavity, usually as a result of joint inflammation.
Musculoskeletal and connective
tissue disorders                 Joint pain                                       Pain in a joint.
Musculoskeletal and connective
tissue disorders                 Joint range of motion decreased                  Decreased joint flexibility.
Musculoskeletal and connective
tissue disorders                 Joint range of motion decreased cervical spine   Decreased flexibility of a cervical spine joint.
Musculoskeletal and connective
tissue disorders                 Joint range of motion decreased lumbar spine     Decreased flexibility of a lumbar spine joint.
Musculoskeletal and connective
tissue disorders                 Kyphosis                                         Abnormally increased curvature of the thoracic portion of the spine.
Musculoskeletal and connective
tissue disorders                 Lordosis                                         Abnormally increased curvature of the lumbar portion of the spinal column.
Musculoskeletal and connective
tissue disorders                 Muscle weakness left-sided                       A reduction in the strength of the muscles in the left side of the body.
Musculoskeletal and connective
tissue disorders                 Muscle weakness lower limb                       A reduction in the strength of the lower limb muscles.
Musculoskeletal and connective
tissue disorders                 Muscle weakness right-sided                      A reduction in the strength of the muscles in the right side of the body.
Musculoskeletal and connective
tissue disorders                 Muscle weakness trunk                            A reduction in the strength of the trunk muscles.
Musculoskeletal and connective
tissue disorders                 Muscle weakness upper limb                       A reduction in the strength of the upper limb muscles.
Musculoskeletal and connective
tissue disorders                 Musculoskeletal deformity                        Congenital or acquired deformity of the musculoskeletal system.
Musculoskeletal and connective
tissue disorders                 Myalgia                                          Painful sensation originating from a muscle or group of muscles.
Musculoskeletal and connective                                                    An inflammatory process affecting the skeletal muscles. Causes include infections, injuries, and
tissue disorders                 Myositis                                         autoimmune disorders.
Musculoskeletal and connective
tissue disorders                 Neck pain                                        Painful sensation in the neck area.
Musculoskeletal and connective
tissue disorders                 Neck soft tissue necrosis                        A necrotic process affecting the soft tissues of the neck.
Musculoskeletal and connective
tissue disorders                 Osteonecrosis                                    Death of bone tissue due to traumatic or nontraumatic causes.
                                                                                  A condition of reduced bone mass, with decreased cortical thickness and a decrease in the number
Musculoskeletal and connective                                                    and size of the trabeculae of cancellous bone (but normal chemical composition), resulting in increased
tissue disorders                 Osteoporosis                                     fracture incidence.
Musculoskeletal and connective                                                    A pathologic bone fracture due to osteoporosis. It is generally caused by a fall from a standing height or
tissue disorders                 Osteoporotic fracture                            lower and usually involves the spine, hip, or wrist.
Musculoskeletal and connective
tissue disorders                 Pain in extremity                                Painful sensation in the upper or lower extremities.
Musculoskeletal and connective
tissue disorders                 Pelvic soft tissue necrosis                      A necrotic process affecting the soft tissues of the pelvis.
Musculoskeletal and connective
tissue disorders                 Scoliosis                                        A congenital or acquired spine deformity characterized by lateral curvature of the spine.
Musculoskeletal and connective
tissue disorders                 Soft tissue necrosis lower limb                  A necrotic process affecting the soft tissues of the lower extremity.



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Musculoskeletal and connective
tissue disorders                      Soft tissue necrosis upper limb            A necrotic process affecting the soft tissues of the upper extremity.
Musculoskeletal and connective
tissue disorders                      Superficial soft tissue fibrosis           Fibrotic degeneration of the superficial soft tissues.
Musculoskeletal and connective                                                   Lack of ability to open the mouth fully due to decreased range of motion of the muscles of mastication.
tissue disorders                      Trismus                                    It may be a symptom of tetanus.
Musculoskeletal and connective
tissue disorders                      Unequal limb length                        Discrepancy between the lengths of the lower or upper extremities.
Musculoskeletal and connective
tissue disorders                      Upper extremity dysfunction                Impaired functioning of the upper extremity.

Neoplasms benign, malignant and                                                  A collection of fluid in the pleural cavity as a result of malignant disease, contains free-floating
unspecified (incl cysts and polyps)   Malignant pleural effusion                 malignant cells.

Neoplasms benign, malignant and                                                  A clonal hematopoietic disorder characterized by dysplasia and ineffective hematopoiesis in one or
unspecified (incl cysts and polyps)   Myelodysplastic syndrome                   more of the hematopoietic cell lines.
                                                                                 A late complication of cancer therapy, possibly related to treatment modality or to an inherent genetic
Neoplasms benign, malignant and                                                  susceptibility such as mutation in p53. Much of the current data has been derived from patients treated
unspecified (incl cysts and polyps)   Treatment related secondary malignancy     in childhood and/or patients treated for Hodgkins lymphoma.

Neoplasms benign, malignant and                                                  A condition of metabolic abnormalities that result from a spontaneous or therapy-related cytolysis of
unspecified (incl cysts and polyps)   Tumor lysis syndrome                       tumor cells.

Neoplasms benign, malignant and
unspecified (incl cysts and polyps)   Tumor pain                                 A painful sensation caused by the tumor growth.

Nervous system disorders              Abducens nerve disorder                    A non-neoplastic or neoplastic disorder affecting the abducens nerve (sixth cranial nerve).

Nervous system disorders              Accessory nerve disorder                   A non-neoplastic or neoplastic disorder affecting the accessory nerve (eleventh cranial nerve).
Nervous system disorders              Acoustic nerve disorder NOS                A non-neoplastic or neoplastic disorder affecting the acoustic nerve.
                                                                                 An uncomfortable feeling of inner restlessness and inability to stay still; this is a side effect of some
Nervous system disorders              Akathisia                                  psychotropic drugs.
                                                                                 Systematic and extensive loss of memory caused by organic or psychological factors. The loss may be
Nervous system disorders              Amnesia                                    temporary or permanent, and may involve old or recent memories.
                                                                                 A term referring to the inability to speak. It may result from injuries to the vocal cords or may be
Nervous system disorders              Aphonia                                    functional (psychogenic).
Nervous system disorders              Arachnoiditis                              Inflammation of the arachnoid membrane and adjacent subarachnoid space.
                                                                                 Lack of coordination of muscle movements resulting in the impairment or inability to perform voluntary
Nervous system disorders              Ataxia                                     activities.
                                                                                 A brachial plexus disorder characterized by regional paresthesia, pain and muscle weakness, and
Nervous system disorders              Brachial plexopathy                        limited movement in the arm or hand.
Nervous system disorders              Central nervous system necrosis            A necrotic process affecting the brain and/or spinal cord.
Nervous system disorders              Cerebrospinal fluid leakage                The loss of cerebrospinal fluid into the surrounding tissues.
Nervous system disorders              Cognitive disturbance                      A notable change in cognitive function.
Nervous system disorders              Concentration impairment                   Deterioration in the ability to concentrate.
Nervous system disorders              Depressed level of consciousness           A neurologic state characterized by decreased ability to perceive and respond.
                                                                                 A medically indistinct term used to describe a variety of conditions such as lightheadedness,
Nervous system disorders              Dizziness                                  unsteadiness, giddiness, a sense of turning, spinning or rocking.

Nervous system disorders              Dysarthria                                 Slow and slurred speech resulting from inability to coordinate the muscles that are used in speech.




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                                                                    Distortion of a sense resulting in an abnormal and unpleasant sensation, usually described as burning,
Nervous system disorders   Dysesthesia                              tingling, or numbness. Causes include lesions of the nervous system.

Nervous system disorders   Dysgeusia                                Abnormal appreciation of the taste of foodstuffs, can be related to decreased sense of smell.
Nervous system disorders   Dysphasia                                Impairment of verbal communication skills, often resulting from brain damage.
Nervous system disorders   Edema cerebral                           Swelling due to an excessive accumulation of fluid in the brain.
Nervous system disorders   Encephalopathy                           A functional and/or structural disorder of the brain.
                                                                    A movement disorder caused by defects in the basal ganglia. The clinical manifestations include
Nervous system disorders   Extrapyramidal disorder                  changes in the muscle tone, dyskinesia, and akinesia.
Nervous system disorders   Facial muscle weakness                   A reduction in the strength of the facial muscles.
Nervous system disorders   Facial nerve disorder                    A non-neoplastic or neoplastic disorder affecting the facial nerve (seventh cranial nerve).

Nervous system disorders   Glossopharyngeal nerve disorder          A non-neoplastic or neoplastic disorder affecting the glossopharyngeal nerve (ninth cranial nerve).
Nervous system disorders   Headache                                 Pain in various parts of the head, not confined to the area of distribution of any nerve.
                                                                    A constellation of signs and symptoms characterized by changes in personality, consciousness, and
                                                                    reflexes, resulting from neuropsychiatric abnormalities secondary to liver failure without evidence of
Nervous system disorders   Hepatic encephalopathy                   other brain disease.
Nervous system disorders   Hydrocephalus                            An abnormal increase of cerebrospinal fluid in the ventricles of the brain.
Nervous system disorders   Hypersomnia                              A sleep disorder characterized by excessive sleepiness during the daytime.

Nervous system disorders   Hypoglossal nerve disorder               A non-neoplastic or neoplastic disorder affecting the hypoglossal nerve (twelfth cranial nerve).
Nervous system disorders   Intracranial hemorrhage                  Bleeding within the cranium.
                                                                    Diminished or absent blood supply to the brain caused by obstruction (thrombosis or embolism) of an
Nervous system disorders   Ischemia cerebrovascular                 artery resulting in neurologic damage.
Nervous system disorders   IVth nerve disorder                      A non-neoplastic or neoplastic disorder affecting the trochlear nerve (IVth cranial nerve).
Nervous system disorders   Lethargy                                 Decreased consciousness characterized by mental and physical inertness.

                                                                    White matter changes first described in children with leukemia, associated with radiation and
                                                                    chemotherapy injury, often associated with methotrexate; pathologically characterised by diffuse
Nervous system disorders   Leukoencephalopathy                      reactive astrocytosis with multiple areas of necrotic foci without inflammation.
Nervous system disorders   Memory impairment                        Deterioration in memory function.

Nervous system disorders   Meningismus                              The symptoms of neck stiffness, headache, and photophobia resulting from meningeal irritation.
Nervous system disorders   Movements involuntary                    Uncontrolled and purposeless movements.
                                                                    An inflammatory process affecting the spinal cord. Symptoms include weakness, paresthesia, sensory
Nervous system disorders   Myelitis                                 loss, pain, and incontinence.
                                                                    Intense painful sensation along a nerve or group of nerves. It is caused by irritation or trauma to a
Nervous system disorders   Neuralgia                                nerve or inflammation of a nerve.
Nervous system disorders   Nystagmus                                Involuntary to and fro movements of the eyeballs.

Nervous system disorders   Oculomotor nerve disorder                A non-neoplastic or neoplastic disorder affecting the oculomotor nerve (third cranial nerve).
Nervous system disorders   Olfactory nerve disorder                 A non-neoplastic or neoplastic disorder affecting the olfactory nerve (first cranial nerve).
                                                                     Functional disturbances of sensory neurons resulting in abnormal cutaneous sensations of tingling,
                                                                    numbness, pressure, cold, and warmth that an individual experiences without the presence of a
Nervous system disorders   Paresthesia                              stimulus.
Nervous system disorders   Peripheral motor neuropathy              Inflammation or degeneration of the peripheral motor nerves.
Nervous system disorders   Peripheral sensory neuropathy            Inflammation or degeneration of the sensory nerves.

Nervous system disorders   Phantom pain                             Painful sensation related to a limb or an organ that is removed from or is not physically part of the body.
Nervous system disorders   Presyncope                               An episode of lightheadedness and dizziness which may precede an episode of syncope.




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                                                                        Dysfunction of the corticospinal (pyramidal) tracts of the spinal cord. Symptoms include increased
                                                                        muscle tone in the lower extremities, hyperreflexia, positive Babinski, and decreased fine motor
Nervous system disorders    Pyramidal tract syndrome                    coordination.
                                                                        An inflammatory process affecting a nerve root. Patients experience pain radiating along a nerve path
Nervous system disorders    Radiculitis                                 because of spinal pressure on the nerve root that connects to the nerve path.
Nervous system disorders    Recurrent laryngeal nerve palsy             Paralysis of the recurrent laryngeal nerve.
                                                                        An acute or subacute reversible condition characterized by headaches, mental status changes, visual
                                                                        disturbances, and seizures associated with imaging findings of posterior leukoencephalopathy. It has
                            Reversible posterior leukoencephalopathy    been observed in association with hypertensive encephalopathy, eclampsia, and immunosuppressive
Nervous system disorders    syndrome                                    and cytotoxic drug treatment.
Nervous system disorders    Seizure                                     Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.

Nervous system disorders    Sinus pain                                  Painful sensation in the face, between the eyes, or upper teeth originating from the sinuses.
Nervous system disorders    Somnolence                                  A sleep disorder characterized by excessive sleepiness and drowsiness.

                                                                        Increased involuntary muscle tone caused by central nervous system disorders that affect the regions
Nervous system disorders    Spasticity                                  interfering with voluntary movement. It results in gait, movement, and speech disturbances.

                                                                        A sudden, nonconvulsive loss of neurologic function due to an ischemic or hemorrhagic intracranial
                                                                        vascular event. In general, cerebrovascular accidents are classified by anatomic location in the brain,
                                                                        vascular distribution, etiology, age of the affected individual, and hemorrhagic vs. nonhemorrhagic
Nervous system disorders    Stroke                                      nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)
Nervous system disorders    Syncope                                     A spontaneous loss of consciousness caused by insufficient blood supply to the brain.
                                                                        A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no
Nervous system disorders    Transient ischemic attacks                  persistent neurological deficit.
                                                                        The shaking movement of the whole body or just a certain part of it, often caused by problems of the
Nervous system disorders    Tremor                                      neurons responsible for muscle action.
Nervous system disorders    Trigeminal nerve disorder                   A non-neoplastic or neoplastic disorder affecting the trigeminal nerve (fifth cranial nerve).
Nervous system disorders    Vagus nerve disorder                        A non-neoplastic or neoplastic disorder affecting the vagus nerve (tenth cranial nerve).
                                                                        Sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of
                                                                        consciousness. It results from an increase in the activity of the vagus nerve. It may be triggered by
Nervous system disorders    Vasovagal reaction                          emotions of fear or pain or gastrointestinal upset
                                                                        Death in utero; failure of the product of conception to show evidence of respiration, heartbeat, or
Pregnancy, puerperium and                                               definite movement of a voluntary muscle after expulsion from the uterus, with no possibility of
perinatal conditions        Fetal death                                 resuscitation.
Pregnancy, puerperium and
perinatal conditions        Fetal growth retardation                    Inhibition of fetal growth resulting in the inability of the fetus to achieve its potential size.
                                                                        Ouster of a viable infant before the normal end of gestation, commonly defined as interruption of
Pregnancy, puerperium and                                               pregnancy between the twentieth-thirty seventh completed weeks after the onset of the last menstrual
perinatal conditions        Premature delivery                          cycle.
Pregnancy, puerperium and
perinatal conditions        Unintended pregnancy                        A pregnancy that was not desired or was timed incorrectly at the time that the conception occurred.
Psychiatric disorders       Agitation                                   A state of restlessness associated with unpleasant feelings of irritability and tension.
Psychiatric disorders       Anorgasmia                                  Inability to achieve orgasm.
                                                                        Apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea
Psychiatric disorders       Anxiety                                     unattached to a clearly identifiable stimulus.
Psychiatric disorders       Confusion                                   A mental state characterized by a lack of clear and orderly thought and behavior.
Psychiatric disorders       Delayed orgasm                              Sexual dysfunction characterized by a delay in climax.
                                                                        A usually reversible condition characterized by the acute and sudden development of confusion,
Psychiatric disorders       Delirium                                    illusions, movement changes, inattentiveness, agitation, and hallucinations.




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Psychiatric disorders            Delusions                          False personal beliefs held contrary to reality, despite contradictory evidence and common sense.
Psychiatric disorders            Depression                         Feelings of grief or unhappiness. A melancholy feeling of sadness and despair.
Psychiatric disorders            Euphoria                           An exaggerated feeling of well-being which is disproportionate to events and stimuli.
                                                                    A false sensory perception in the absence of an external stimulus, as distinct from an illusion which is a
Psychiatric disorders            Hallucinations                     misperception of an external stimulus.
Psychiatric disorders            Insomnia                           A sleep disorder characterized by difficulty in falling asleep and/or remaining asleep.
Psychiatric disorders            Libido decreased                   Decreased sexual desire.
Psychiatric disorders            Libido increased                   Increased sexual desire.
                                                                    Excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganisation of
Psychiatric disorders            Mania                              behaviour and elevation of mood.
Psychiatric disorders            Personality change                 A noticeable change in a person's behavior and thinking.

                                                                    A mental disorder characterized by personality change, impaired functioning, and loss of touch with
Psychiatric disorders            Psychosis                          reality. It may be a manifestation of schizophrenia, bipolar disorder, or brain tumor.
Psychiatric disorders            Restlessness                       An inability to rest, relax, or be still.
Psychiatric disorders            Suicidal Ideation                  Thoughts of taking one's own life.
Psychiatric disorders            Suicide attempt                    Self-inflicted harm in an attempt to end one's own life.

                                                                    A clinical syndrome characterized by a sudden decrease in glomerular filtration rate, often to values of
                                                                    less than 1 to 2 ml per minute. It is usually associated with oliguria (urine volumes of less than 400 ml
                                                                    per day) and is always associated with biochemical consequences of the reduction in glomerular
Renal and urinary disorders      Acute kidney injury                filtration rate such as a rise in blood urea nitrogen (BUN) and serum creatinine concentrations.
Renal and urinary disorders      Bladder perforation                A rupture in the bladder wall due to traumatic or pathologic processes.
Renal and urinary disorders      Bladder spasm                      A sudden and involuntary contraction of the bladder wall.
                                                                    An inflammation of the bladder which is not caused by an infection of the urinary tract. Representative
Renal and urinary disorders      Cystitis noninfective              examples include interstitial cystitis and radiation-induced cystitis.
Renal and urinary disorders      Hematuria                          Blood in the urine.
Renal and urinary disorders      Hemoglobinuria                     A laboratory test result which indicates free hemoglobin in the urine.
Renal and urinary disorders      Proteinuria                        The presence of excessive protein, chiefly albumin but also globulin, in the urine.
Renal and urinary disorders      Renal Calculi                      The formation of crystal in the pelvis of the kidney.
                                                                    Paroxysmal and severe flank pain radiating to the inguinal area. It is caused by the passage of a
Renal and urinary disorders      Renal colic                        kidney stone through the ureter.
Renal and urinary disorders      Renal hemorrhage                   Bleeding originating from the kidney.

Renal and urinary disorders      Urinary Fistula                    An abnormal communication between any part of the urinary system and another organ or cavity.
Renal and urinary disorders      Urinary incontinence               Inability to control the flow of urine from the bladder.
Renal and urinary disorders      Urinary Pain                       A painful sensation in the rrinary tract.
Renal and urinary disorders      Urinary retention                  Accumulation of urine within the bladder because of the inability to urinate.
Renal and urinary disorders      Urinary tract obstruction          Blockage of the normal flow of contents of the urinary tract.
                                                                    Change in the color of the urine. Causes include medications, vitamins, urinary tract infection, liver
Renal and urinary disorders      Urine discoloration                disease, hemolysis, and kidney cancer.
Reproductive system and breast
disorders                        Azospermia                         Complete absence of spermatozoa in the semen.
Reproductive system and breast
disorders                        Breast atrophy                     Underdevelopment of the breast.
Reproductive system and breast
disorders                        Breast pain                        Painful sensation in the breast region.
Reproductive system and breast
disorders                        Dyspareunia                        Painful or difficult coitus.




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Reproductive system and breast                                         A disorder referring to problems related to ejaculation. This category includes premature, delayed,
disorders                        Ejaculation disorder                  retrograde, and painful ejaculation.
Reproductive system and breast                                         A disorder characterized by the persistent or recurrent inability to achieve or to maintain an erection
disorders                        Erectile dysfunction                  during sexual activity.
Reproductive system and breast
disorders                        Fallopian tube obstruction            Blockage of the normal flow of the contents in the fallopian tube.
Reproductive system and breast
disorders                        Fallopian tube perforation            A rupture of the fallopian tube wall due to tubal pregnancy, or other traumatic or pathologic processes.
Reproductive system and breast
disorders                        Fallopian tube stenosis               Narrowing of the lumen of the fallopian tube.
Reproductive system and breast
disorders                        Female genital tract fistula          An abnormal communication between a female reproductive system organ and another organ or cavity.
Reproductive system and breast
disorders                        Feminization acquired                 The development of secondary female sex characteristics in males due to extrinsic factors.
Reproductive system and breast
disorders                        Genital edema                         Swelling due to an excessive accumulation of fluid in the genitals.
Reproductive system and breast                                         Excessive development of the breasts in males; usually the result of hormonal imbalance or treatment
disorders                        Gynecomastia                          with certain drugs.
Reproductive system and breast
disorders                        Hematosalpinx                         The presence of blood in a fallopian tube.
Reproductive system and breast                                         A disorder not necessarily related to pregnancy that is observed in females and males. It is
disorders                        Lactation disorder                    characterized by disturbances of milk secretion.
Reproductive system and breast                                         The permanent cessation of menses, usually defined by 6 to 12 months of amenorrhea in a woman
disorders                        Menopause                             over 45 years of age.
Reproductive system and breast
disorders                        Menorrhagia                           Abnormally heavy menstrual bleeding. [from NCI Dictionary of Cancer Terms]
Reproductive system and breast
disorders                        Nipple deformity                      A congenital or acquired deformity of the nipple.
Reproductive system and breast
disorders                        Oligospermia                          Decreased number of spermatozoa in the semen.
Reproductive system and breast
disorders                        Ovarian hemorrhage                    Bleeding originating from the ovary.
Reproductive system and breast
disorders                        Ovarian rupture                       Tearing or disruption of the ovarian tissue.
Reproductive system and breast                                         Painful sensation in one side of the abdomen between menstrual cycles, around the time of the
disorders                        Ovulation pain                        discharge of the ovum from the ovarian follicle.
Reproductive system and breast
disorders                        Pelvic floor muscle weakness          A reduction in the strength of the muscles of the pelvic floor.
Reproductive system and breast
disorders                        Pelvic pain                           Painful sensation in the pelvis.
Reproductive system and breast
disorders                        Penile pain                           Painful sensation in the penis.
Reproductive system and breast
disorders                        Perineal pain                         Painful sensation in the perineal area.
Reproductive system and breast                                         Ovarian failure before the age of 40. Symptoms include hot flashes, night sweats, mood swings, and
disorders                        Premature menopause                   decreased sex drive.
Reproductive system and breast                                         A non-neoplastic or neoplastic disorder affecting the prostate gland. Representative examples include
disorders                        Prostatic disorder                    prostatitis, benign prostatic hyperplasia, and cancer.
Reproductive system and breast
disorders                        Prostatic hemorrhage                  Bleeding originating from the prostate gland.




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Reproductive system and breast                                       Squeezing of the urethra secondary to enlargement of the prostate gland, resulting in voiding
disorders                        Prostatic obstruction               symptoms (straining to void, slow urine stream, and incomplete emptying of the bladder).
Reproductive system and breast
disorders                        Prostatic pain                      Pain in the prostate gland.
Reproductive system and breast
disorders                        Scrotal pain                        Painful sensation in the scrotal area.
Reproductive system and breast
disorders                        Spermatic cord hemorrhage           Bleeding originating from the spermatic cord.
Reproductive system and breast
disorders                        Spermatic cord obstruction          Blockage of the normal flow of the contents of the spermatic cord.

Reproductive system and breast                                       A non-neoplastic or neoplastic disorder affecting the testis. Representative examples include torsion,
disorders                        Testicular disorder                 infarction, germ cell tumor, sex cord-stromal tumor, lymphoma, and leukemia.
Reproductive system and breast
disorders                        Testicular hemorrhage               Bleeding originating from the testis.
Reproductive system and breast
disorders                        Testicular pain                     A painful sensation in the testis.
Reproductive system and breast
disorders                        Uterine fistula                     An abnormal communication between the uterus and another organ.
Reproductive system and breast
disorders                        Uterine hemorrhage                  Bleeding originating from the uterus.
Reproductive system and breast
disorders                        Uterine obstruction                 Blockage of the uterine outlet. Causes include uterine tumors and adhesions.
Reproductive system and breast
disorders                        Uterine pain                        A painful sensation in the uterus.
Reproductive system and breast
disorders                        Uterine perforation                 A rupture in the uterus due to traumatic or pathologic processes.
Reproductive system and breast                                       Normal or abnormal secretions from the vagina. Mucus produced by the cervical glands is discharged
disorders                        Vaginal discharge                   from the vagina naturally, especially during the childbearing years.
                                                                     An uncomfortable feeling of itching and burning in the vaginal opening resulting from inadequate
Reproductive system and breast                                       vaginal lubrication. It is commonly seen during and after menopause, childbirth, or stressful conditions.
disorders                        Vaginal dryness                     It results in painful intercourse.
Reproductive system and breast
disorders                        Vaginal fistula                     An abnormal communication between the vagina and another organ or cavity.
Reproductive system and breast
disorders                        Vaginal hemorrhage                  Bleeding originating from the vagina.
Reproductive system and breast
disorders                        Vaginal inflammation                Redness and edema affecting the vagina. Symptoms may include pain and purulent discharge.
Reproductive system and breast
disorders                        Vaginal obstruction                 Congenital or acquired blockage of the vagina.
Reproductive system and breast
disorders                        Vaginal pain                        A painful sensation in the vagina.
Reproductive system and breast
disorders                        Vaginal perforation                 A rupture in the vaginal wall due to traumatic or pathologic processes.
Reproductive system and breast
disorders                        Vaginal stricture                   Narrowing of the vaginal lumen.
                                                                     Tightness of the vaginal wall during vaginal penetration including sexual intercourse. It is caused by
Reproductive system and breast                                       involuntary spasm of the pelvic floor muscles, and results in painful intercourse or failure to have
disorders                        Vaginismus                          intercourse. It may be due to psychological conditions




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Reproductive system and breast
disorders                        Vas deferens hemorrhage                      Bleeding originating from the vas deferens.
Reproductive system and breast
disorders                        Vas deferens obstruction                     Blockage of the normal flow of the sperm in the vas deferens.
Respiratory, thoracic and                                                     Progressive and life-threatening pulmonary distress in the absence of an underlying pulmonary
mediastinal disorders            Adult respiratory distress syndrome          condition, usually following major trauma or surgery.

                                                                              Inflammation of the nasal mucous membranes caused by an IgE-mediated response to external
                                                                              allergens. The inflammation may also involve the mucous membranes of the sinuses, eyes, middle ear,
Respiratory, thoracic and                                                     and pharynx. Symptoms include sneezing, nasal congestion, rhinorrhea, and itching. It may lead to
mediastinal disorders            Allergic rhinitis                            fatigue, drowsiness, and malaise thus causing impairment of the quality of life.
Respiratory, thoracic and
mediastinal disorders            Apnea                                        Cessation of breathing. Transient cessation of respiration.
Respiratory, thoracic and
mediastinal disorders            Aspiration                                   Pneumonia secondary to aspiration of liquids and gastric contents into the lungs.
Respiratory, thoracic and
mediastinal disorders            Atelectasis                                  The collapse of part or the entire lung due to airway obstruction, infection, tumor, or general anesthesia.
Respiratory, thoracic and
mediastinal disorders            Bronchial fistula                            An abnormal communication between the bronchus and another organ or anatomic site.
Respiratory, thoracic and
mediastinal disorders            Bronchial hemorrhage                         Bleeding from the bronchial wall and/or lung parenchyma.
Respiratory, thoracic and
mediastinal disorders            Bronchial obstruction                        Blockage of a bronchus passage most often by bronchial secretions and exudates.
Respiratory, thoracic and
mediastinal disorders            Bronchial stricture                          Narrowing of a bronchial tube.
Respiratory, thoracic and
mediastinal disorders            Bronchopulmonary hemorrhage                  Bleeding from the bronchial wall and/ or lung parenchyma.
Respiratory, thoracic and
mediastinal disorders            Bronchospasm                                 Sudden contraction of the smooth muscles of the bronchial wall.
Respiratory, thoracic and
mediastinal disorders            Chylothorax                                  A milky pleural effusion resulting from accumulation of lymph fluid in the pleural cavity.
Respiratory, thoracic and                                                     A sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of
mediastinal disorders            Cough                                        air from the lungs, and usually accompanied by a distinctive sound.
Respiratory, thoracic and                                                     An unusual sensation in the area of pharynx. It may be the initial manifestation of seizures associated
mediastinal disorders            Dysesthesia pharynx                          with temporal lobe epilepsy.
Respiratory, thoracic and                                                     An uncomfortable sensation of difficulty breathing. It may present as an acute or chronic sign of an
mediastinal disorders            Dyspnea                                      underlying respiratory or heart disorder.
Respiratory, thoracic and
mediastinal disorders            Epistaxis                                    Bleeding from the nose.
Respiratory, thoracic and                                                     A diaphragmatic spasm causing a sudden inhalation which is interrupted by a spasmodic closure of the
mediastinal disorders            Hiccups                                      glottis, producing a noise.

Respiratory, thoracic and                                                     Harsh and raspy voice secondary to laryngeal infection, voice overuse, irritants inhalation, vocal cord
mediastinal disorders            Hoarseness                                   paralysis, vocal cord polyps, and malignant neoplasms arising from or spreading to the larynx.
Respiratory, thoracic and                                                     A decrease in the amount of oxygen in the body. Symptoms range from mild (impaired judgment,
mediastinal disorders            Hypoxia                                      memory loss, impaired motor coordination) to severe (seizures and coma).
Respiratory, thoracic and
mediastinal disorders            Laryngeal edema                              Swelling due to an excessive accumulation of fluid in the larynx.
Respiratory, thoracic and
mediastinal disorders            Laryngeal fistula                            An abnormal communication between the larynx and another organ or cavity.




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Respiratory, thoracic and
mediastinal disorders       Laryngeal hemorrhage                   Bleeding originating from the larynx.
Respiratory, thoracic and                                          An acute or chronic, bacterial or viral inflammatory process affecting the larynx. Symptoms include sore
mediastinal disorders       Laryngeal inflammation                 throat, cough, swallowing difficulties, and hoarseness.
Respiratory, thoracic and
mediastinal disorders       Laryngeal mucositis                    An inflammatory process affecting the mucous membrane of the larynx.
Respiratory, thoracic and
mediastinal disorders       Laryngeal obstruction                  Blockage of the laryngeal airway passage.
Respiratory, thoracic and
mediastinal disorders       Laryngeal stenosis                     Narrowing of the laryngeal airway.
Respiratory, thoracic and
mediastinal disorders       Laryngopharyngeal dysesthesia          An uncomfortable persistent sensation in the area of the laryngopharynx.

                                                                   Paroxysmal spasmodic muscular contraction of the vocal cords. It is brief, usually lasting for less than
Respiratory, thoracic and                                          one minute, interrupting the speech and breathing and may produce a high-pitched breathing sound. It
mediastinal disorders       Laryngospasm                           may occur under anesthesia or may be associated with gastroesophageal reflux disease.
Respiratory, thoracic and
mediastinal disorders       Mediastinal hemorrhage                 Bleeding originating from the mediastinum.
Respiratory, thoracic and                                          The blockage of the nasal passage due to mucosal edema. It is usually the result of a viral infection or
mediastinal disorders       Nasal congestion                       an allergic reaction.
Respiratory, thoracic and
mediastinal disorders       Pharyngeal fistula                     An abnormal communication between the pharynx and another organ or anatomic site.
Respiratory, thoracic and
mediastinal disorders       Pharyngeal hemorrhage                  Bleeding originating from the pharynx.
Respiratory, thoracic and
mediastinal disorders       Pharyngeal mucositis                   An inflammatory process affecting the mucous membrane of the pharynx.
Respiratory, thoracic and
mediastinal disorders       Pharyngeal necrosis                    A necrotic process affecting the pharynx.
Respiratory, thoracic and
mediastinal disorders       Pharyngeal stenosis                    Narrowing of the pharyngeal airway.
Respiratory, thoracic and
mediastinal disorders       Pharyngolaryngeal pain                 Painful sensation in the pharyngolaryngeal region.
Respiratory, thoracic and                                          Increased amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough, and
mediastinal disorders       Pleural effusion                       chest pain.
Respiratory, thoracic and
mediastinal disorders       Pleural fistula                        An abnormal communication between the pleural cavity and another anatomic site.
Respiratory, thoracic and
mediastinal disorders       Pleural hemorrhage                     A collection of blood in the pleural cavity.
Respiratory, thoracic and
mediastinal disorders       Pleuritic pain                         Painful sensation in the pleura.
                                                                   An acute, acute and chronic, or chronic inflammation focally or diffusely affecting the lung parenchyma,
Respiratory, thoracic and                                          due to infections (viruses, fungi, mycoplasma, or bacteria), treatment (e.g. radiation), or exposure
mediastinal disorders       Pneumonitis                            (inhalation) to chemicals. Symptoms include cough
Respiratory, thoracic and
mediastinal disorders       Pneumothorax                           Abnormal presence of air in the pleural cavity resulting in the collapse of the lung.
Respiratory, thoracic and                                          Excessive mucous secretion in the back of the nasal cavity or throat, causing sore throat and/or
mediastinal disorders       Postnasal drip                         coughing.
Respiratory, thoracic and
mediastinal disorders       Productive cough                       Cough that brings up mucous or bloody secretion.




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                                                               Accumulation of fluid in the lung tissues causing disturbance of the gas exchange that may lead to
Respiratory, thoracic and                                      respiratory failure. It is caused by direct injury to the lung parenchyma or congestive heart failure. The
mediastinal disorders          Pulmonary edema                 symptoms may appear suddenly or gradually.

Respiratory, thoracic and                                      Chronic progressive interstitial lung disorder characterized by the replacement of the lung tissue by
mediastinal disorders          Pulmonary fibrosis              connective tissue, leading to progressive dyspnea, respiratory failure, or right heart failure.
Respiratory, thoracic and
mediastinal disorders          Pulmonary fistula               An abnormal communication between the lung and another organ or anatomic site.
Respiratory, thoracic and
mediastinal disorders          Pulmonary hemorrhage            Bleeding from the lung parenchyma.
Respiratory, thoracic and
mediastinal disorders          Pulmonary hypertension          Increased pressure within the pulmonary circulation due to lung or heart disorder.

Respiratory, thoracic and                                      Impaired gas exchange by the respiratory system resulting in hypoxemia and decreased oxygenation of
mediastinal disorders          Respiratory failure             the tissues that may be associated with increased arterial levels of carbon dioxide.
                                                               A syndrome observed in patients with acute promyelocytic leukemia treated with all-trans retinoic acid.
Respiratory, thoracic and                                      It is characterized by weight gain, dyspnea, pleural and pericardial effusions, leukocytosis, and renal
mediastinal disorders          Retinoic acid syndrome          failure.
Respiratory, thoracic and                                      A non-neoplastic or neoplastic disorder affecting the paranasal sinuses. Examples include
mediastinal disorders          Sinus disorder                  inflammation, polyps, and cancer.
                                                               Cessation of breathing for short periods during sleep. It is classified as obstructive, central, or mixed
Respiratory, thoracic and                                      obstructive-central. It can occur at any age but it is more frequent in people over forty. Risk factors
mediastinal disorders          Sleep apnea                     include male sex and obesity.
Respiratory, thoracic and
mediastinal disorders          Sneezing                        A symptom consisting of the involuntary expulsion of air from the nose.
Respiratory, thoracic and                                      Any kind of inflammatory process of the tonsils, pharynx, or/and larynx characterized by pain in
mediastinal disorders          Sore throat                     swallowing.
Respiratory, thoracic and
mediastinal disorders          Stridor                         A symptom resulting from laryngeal obstruction. It is characterized by a high pitched breathing sound.
Respiratory, thoracic and
mediastinal disorders          Tracheal fistula                An abnormal communication between the trachea and another organ or anatomic site.
Respiratory, thoracic and
mediastinal disorders          Tracheal mucositis              An inflammatory process affecting the mucous membrane of the trachea.
Respiratory, thoracic and
mediastinal disorders          Tracheal stenosis               Narrowing of the lumen of the trachea.
Respiratory, thoracic and
mediastinal disorders          Voice alteration                Change in the sound and/or speed of the voice.
                                                               A symptom and a finding during physical examination, characterized by a high-pitched, whistling sound
                                                               during breathing. It results from the narrowing or obstruction of the respiratory airways. The most
Respiratory, thoracic and                                      common causes of wheezing are asthma, chronic obstructive pulmonary disease, tracheobronchitis,
mediastinal disorders          Wheezing                        and pulmonary edema.
Skin and subcutaneous tissue
disorders                      Alopecia                        Loss of hair from the head or body
Skin and subcutaneous tissue
disorders                      Body odor                       Body smell resulting from the growth of bacteria on the body.
Skin and subcutaneous tissue
disorders                      Bullous dermatitis              Inflammation of the skin characterized by the presence of bullae which are filled with fluid.
Skin and subcutaneous tissue                                   The pores are generally fine with a papery thin texture that feels dry to the touch. Usually flaky and dull
disorders                      Dry skin                        looking.




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                                                                            Erythema multiforme is a skin condition of unknown etiology, possibly mediated by deposition of
                                                                            immune complex ( mostly IgM ) in the superficial microvasculature of the skin and oral mucous
Skin and subcutaneous tissue                                                membrane that usually follows an antecedent infection or drug exposure.It is characterized by target
disorders                      Erythema multiforme                          lesions (a pink-red ringaround a pale center).
Skin and subcutaneous tissue                                                A generalized inflammatory cutaneous disorder characterized by erythema and exfoliation. The
disorders                      Erythroderma                                 inflammatory process involving > 90% of the body surface area.
Skin and subcutaneous tissue
disorders                      Fat atrophy                                  Shrinking of adipose tissue.
Skin and subcutaneous tissue
disorders                      Hyperhidrosis                                Excessive perspiration.
Skin and subcutaneous tissue                                                Generalized or localized hair growth of abnormal length and density. It may be congenital or acquired
disorders                      Hypertrichosis                               (e.g., drug-induced).
Skin and subcutaneous tissue
disorders                      Hypohidrosis                                 Reduced sweating.
Skin and subcutaneous tissue                                                Hypertrophy of the subcutaneous adipose tissue at the site of multiple subcutaneous injections of
disorders                      Lipohypertrophy                              insulin.
Skin and subcutaneous tissue
disorders                      Nail discoloration                           A change in the color of the nail plate
Skin and subcutaneous tissue
disorders                      Nail loss                                    The destruction of all or a portion of a nail.
                                                                            Straight elevated lines on the nail surface. Ridges may be vertical (running from the cuticle to the nail
Skin and subcutaneous tissue                                                tip) or horizontal (running from one side of the nail to the other). Vertical ridges are usually not
disorders                      Nail ridging                                 associated with underlying disorders.
Skin and subcutaneous tissue
disorders                      Pain of skin                                 Painful sensation in the skin.
Skin and subcutaneous tissue                                                A condition characterized by redness, pain, swelling, and tingling in the palms of the hands or the soles
disorders                      Palmar-plantar erythrodysesthesia syndrome   of the feet.
                                                                            Eruption consisting of papules and pustules, typically appearing in face, scalp, and upper chest and
Skin and subcutaneous tissue                                                back. Unlike acne, this rash does not present with whiteheads or blackheads, and can be
disorders                      Papulopustular rash                          symptomatic, wiith itchy or tender lesions.
Skin and subcutaneous tissue
disorders                      Periorbital edema                            Swelling due to an excessive accumulation of fluid around the orbits of the face.
Skin and subcutaneous tissue
disorders                      Photosensitivity                             Increased sensitivity of the skin to light.
Skin and subcutaneous tissue
disorders                      Pruritus                                     An itching sensation.

Skin and subcutaneous tissue                                                A hemorrhagic area of the skin and mucous membrane. Newer lesions appear reddish in color. Older
disorders                      Purpura                                      lesions are usually a darker purple color and eventually become a brownish-yellow color.
                                                                            Eruption consisting of papules and pustules, typically appearing in face, scalp, and upper chest and
                                                                            back. Usually caused by corticosteroids or epidermal growth factor receptor inhibitors. Unlike acne, this
Skin and subcutaneous tissue                                                rash does not present with whiteheads or blackheads, and can be symptomatic, wiith itchy or tender
disorders                      Rash acneiform                               lesions.
                                                                            A skin condition consisting of both macules (flat) and papules (elevated). Also known as morbillform
Skin and subcutaneous tissue                                                rash, it is one of the most common cutaneous adverse events, frequently affecting the upper trunk,
disorders                      Rash maculo-papular                          spreading centripetally and associated with pruritus.
Skin and subcutaneous tissue
disorders                      Scalp pain                                   Painful sensation in the skin covering the top and the back of the head.
Skin and subcutaneous tissue
disorders                      Skin atrophy                                 The degeneration and thinning of the epidermis and dermis. It is usually a manifestation of aging.




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Skin and subcutaneous tissue                                         Darkening of the skin due to excessive melanin deposition. Causes include skin injuries, pregnancy,
disorders                      Skin hyperpigmentation                eczema, and Addison disease.
Skin and subcutaneous tissue                                         Loss of skin pigment. Vitiligo, albinism, and leukoderma are among the disorders that are associated
disorders                      Skin hypopigmentation                 with skin hypopigmentation.
Skin and subcutaneous tissue
disorders                      Skin induration                       An area of hardness in the skin.
Skin and subcutaneous tissue                                         A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface
disorders                      Skin ulceration                       resulting in necrosis of tissue
                                                                     Stevens-Johnson syndrome (SJS) is a life-threatening condition affecting the skin in which cell death
                                                                     causes the epidermis to separate from the dermis in less than 10% of body surface area. The
                                                                     syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.
Skin and subcutaneous tissue                                         Although the majority of cases are idiopathic, the main class of known causes is medications, followed
disorders                      Stevens-Johnson syndrome              by infections and (rarely) cancers.
Skin and subcutaneous tissue
disorders                      Telangiectasia                        Local dilatation of small vessels resulting in red discoloration of the skin or mucous membranes.
                                                                     Toxic epidermal necrolysis (TEN) is a life-threatening condition affecting the skin in which cell death
                                                                     causes the epidermis to separate from the dermis in more than 30% of body surface area. The
                                                                     syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.
Skin and subcutaneous tissue                                         Although the majority of cases are idiopathic, the main class of known causes is medications, followed
disorders                      Toxic epidermal necrolysis            by infections and (rarely) cancers.
Skin and subcutaneous tissue
disorders                      Urticaria                             An itchy skin eruption characterized by weals with pale interiors and well-defined red margins.

                                                                     A syndrome characterized by leakage of intravascular fluids into the extravascular space. his syndrome
                                                                     is observed in patients who demonstrate a state of generalized leaky capillaries following shock
                                                                     syndromes, low-flow states, ischemia-reperfusion injuries, toxemias, medications, or poisoning. It can
Vascular disorders             Capillary leak syndrome               lead to generalized edema and multiple organ failure.
Vascular disorders             Flushing                              A sudden reddening of the face.
                                                                     A localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall
Vascular disorders             Hematoma                              of a blood vessel.

Vascular disorders             Hot flashes                           A temporary feeling of intense body warmth, flushing, sometimes accompanied by sweating.
                                                                     Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90
Vascular disorders             Hypertension                          mmHg.
                                                                     Any blood pressure that is below the normal expected for an individual in a given environment. Blood
Vascular disorders             Hypotension                           pressure that is below the normal value range.
Vascular disorders             Lymph leakage                         The loss of lymph into the surrounding tissue or body cavity.
                                                                     Excess fluid collection in tissues, causing swelling. It is the result of obstruction of lymphatic vessels or
Vascular disorders             Lymphedema                            lymph nodes.
Vascular disorders             Lymphocele                            A cystic lesion containing lymph.
Vascular disorders             Peripheral ischemia                   Disorder caused by the occlusion of the lumen of the peripheral arteries.
Vascular disorders             Phlebitis                             Inflammation of a vein.
                                                                     Thrombosis and inflammation of a superficial vein of the extremities. Symptoms include red
Vascular disorders             Superficial thrombophlebitis          discoloration and warmth of the skin and pain along the affected vein.
                                                                     Occlusion of the lumen of a vessel by a thrombus that has migrated from a distal site via the blood
Vascular disorders             Thromboembolic event                  stream.
                                                                     An inflammatory process involving the wall of a vessel that may cause necrosis or formation of
Vascular disorders             Vasculitis                            granulomas in the vascular wall.
                                                                     Decreased blood supply due to narrowing or blockage of a visceral (mesenteric) artery. The ischemia
Vascular disorders             Visceral arterial ischemia            results to the damage to the organs.




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