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					Mocked Up Patient Data - SDTM
 1. Patient Record 1, Primary Condition: Diabetes

           54-year-old man
demographics / med history with diabetes was referred to the Hypertension Clinic in Jichi Medical School Hospital with symptom
           In 2002, he started insulin therapy (Hemoglobin A1c 9 %), and in 2004, he was started on a once daily dose of valsa
medical history
           He
medical historysometimes complained of dizziness and fainting while standing.
           On
medical history13 February 2005, he fell down while riding a bicycle.
           As
medical historythe clinic BP was 84/60 mm Hg on 14 March, and the valsartan was stopped.
             He
medical history was referred to otolaryngology and neurology, but no significant abnormalities were detected.
Visit 1    On 19 April, he was referred to our Hypertension Clinic.
           Laboratory data were: hemoglobin A1c 8.6%, postprandial glucose 12.1 mmol/l, serum creatinine 84.0 mumol/l and
           During a head-up tilt test, BP decreased 50 mm Hg systolic and 27 mm Hg diastolic, and the patient complained of
            After the atenolol was started, with a dose of 6.25 mg on 20 April, the dizziness was relieved, and the dose of ateno
Visit 2    A second head-up tilt test (12 July, Figure 1b) showed improvement of the average supine BP (decreased from 173
            By contrast, the standing BP remained essentially unchanged (from 123/65 to 121/67 mm Hg).
           A second ambulatory BP monitoring showed significant reduction of sleep BP and PR (170/96 mm Hg, PR 93 bpm
           The variability (s.d.) of awake SBP/DBP was also reduced (from 18/12 to 12/8 mm Hg).
           A Valsalva maneuver showed a dysautonomic pattern (a lack of compensatory increase of PR in phase II and overs
           Although a brain MRI showed multiple cerebral and cerebellar infarctions, single photon emission computed tomogr
           Echocardiography showed a cardiac ejection fraction of 84%, but no left ventricular hypertrophy.


CM concomitant meds
                    Unique subject ID    Medication category (eg per administrationdosing
                                                                       dose units
Study ID Domain Abbreviation Reported name of drugOccurrencedosewas the question asked) frequency
STUDYID DOMAIN USUBJID CMTRT             CMCAT      CMOCCURCMDOSE CMDOSU CMDOSFREQ
MOCK     CM                 1 Insulin    blood sugarYcontrol
MOCK     CM                                         Y
                            1 Valstartan hypertension              80 mg                   1

DM = demographics
                                Site ID    age         age units gender          date of collection
STUDYID DOMAIN         USUBJID SITEID      AGE         AGEU       SEX            DMDTC
MOCK    DM                                         54 year         Clinic
                              1 Jichi Medical School, HypertensionMale            19-Apr-05

AE=adverse events (generally during the study timeline)
if we assume the symptoms are adverse effects, they might look like this:
                                              severity    is        is causes cancer, treatment
                                                                                study death)
                                 term used for AE of AEserious (eg related tostart date of AE
STUDYID DOMAIN USUBJID AETERM AESEV                       AESER     AERELNSTAESTDTC
MOCK       AE                 1 dizzyness                 N         N
MOCK       AE                 1 fainting while standing N           N
MOCK       AE                                 moderate
                              1 fell while riding bicycle N         N          13-Feb-05


MH = Medical History
if the symptoms are part of the MH they might look like this
                                                 Category fordate of history collection
                                                                         start
                                   Term for medical history medical historyof medical history event
STUDYID DOMAIN USUBJID MHTERM MHCAT                          MHDTC       MHSTDTC
MOCK        MH                   1 Diabetes Diabetes 14-Mar-05
MOCK        MH                   1 Hypertension              1
                                                 Hypertension4-Mar-05
MOCK        MH                   1 dizzyness                 14-Mar-05
MOCK        MH                   1 fainting while standing 14-Mar-05
MOCK        MH                   1 fell while riding bicycle 14-Mar-05 13-Feb-05
MOCK       MH                   1                Blood pressure
                                    orthostatic intolerance 14-Mar-05
MOCK       MH                   1                hypotension14-Mar-05 14-Mar-05
                                    Blood pressure
MOCK       MH                   1                Nerve / stroke
                                                             14-Mar-05
                                    Normal neurological examevaluation
MOCK       MH                   1                Head and neck
                                                             14-Mar-05
                                    Normal otolaryngology exam


LB = Lab test results                         green=CDISC controlled vocab under public review
                                              short name test test
                                    specimen ID                                   lab test original units
                                                          for name category fororiginal result
STUDYID    DOMAIN       USUBJID     LBREFID LBTESTCDLBTEST LBCAT                 LBORRES LBORRESU
MOCK       LB                  1    1A        HGB        HemoglobinHematology            8.6 %
MOCK       LB                  1    1B        GLUC       Glucose Clinical chemistry 12.1 mmol/L
MOCK       LB                  1    1B        CREAT                              84.0
                                                         creatinine Clinical chemistry       mumol/L
MOCK       LB                  1    1C        TPRO       total proteinUrinalysis 2+


PE = Physical exam
                                               test name                   lab test original units haracter result
                                    body system examinedcategory fororiginal result              C
STUDYID    DOMAIN       USUBJID     PETESTCD   PETEST PECAT               PEORRES PEORRESU       PESTRESC
MOCK       PE                  1                             test; systolic        50 mm Hg
                                    Tilt-SYSBPHead-up tiltVasculature blood pressure
MOCK       PE                  1               Head-up tiltVasculature blood27 mm Hg
                                    Tilt- DIASBP             test; diastolic        pressure
MOCK       PE                  1    Sleep-DIABP             Vasculature
                                               sleep diastolic blood pressure 170 mm Hg
MOCK       PE                  1    Sleep-SYSBP             Vasculature
                                               sleep systolic blood pressure 96 mm Hg
MOCK       PE                  1                             rate
                                    Sleep-PR sleep pulseVasculature                93 bpm
MOCK       PE                  1                            Vasculature           147 mm
                                    Tilt-SYSBPSupine tilt test; systolic blood pressure Hg
MOCK       PE                  1               Supine tilt test; diastolic blood pressureHg
                                    Tilt- DIASBP            Vasculature            82 mm
MOCK       PE                  1                             test; systolic       173 mm Hg
                                    Tilt-SYSBPHead-up tiltVasculature blood pressure
MOCK       PE                  1               Head-up tiltVasculature blood93 mm Hg
                                    Tilt- DIASBP             test; diastolic        pressure
MOCK       PE                  1    Tilt-BP                  blood pressure 100 bpm
                                               Head-up tiltVasculature
MOCK       PE                  1    Tilt-BP                 Vasculature
                                               Supine tilt-blood pressure          67 bpm
MOCK       PE                  1               Standing Vasculature
                                    Standing DIASBP diastolic blood pressure mm Hg 65
MOCK       PE                  1               Standing systolic blood pressure mm Hg
                                    Standing SYSBP          Vasculature           123
MOCK       PE                  1               Standing Vasculature
                                    Standing DIASBP diastolic blood pressure mm Hg 67
MOCK       PE                  1               Standing systolic blood pressure mm Hg
                                    Standing SYSBP          Vasculature           121
MOCK       PE                  1    Sleep-DIABP             Vasculature
                                               sleep diastolic blood pressure 149 mm Hg
MOCK       PE                  1    Sleep-SYSBP             Vasculature
                                               sleep systolic blood pressure 85 mm Hg
MOCK       PE                  1                             rate
                                    Sleep-PR sleep pulseVasculature                70 bpm
MOCK       PE                  1    CircadianBP                           flattened
                                               circadian blood pressure pattern                  flattened
MOCK       PE                  1    VAR-SBP/DBP                                 8-Dec
                                               Variability (s.d.) of awake SBP/DBP                     8-Dec
MOCK       PE                  1    VAR-SBP/DBP                           18/12
                                               Variability (s.d.) of awake SBP/DBP               18/12


diagnosis: orthostatic hypotension 20 April 05
 After the atenolol was started, with a dose of 6.25 mg on 20 April, the dizziness was relieved, and the dose of atenolol was gra


A Valsalva maneuver showed a dysautonomic pattern (a lack of compensatory increase of PR in phase II and overshoot of BP
Although a brain MRI showed multiple cerebral and cerebellar infarctions, single photon emission computed tomography (SPEC
Echocardiography showed a cardiac ejection fraction of 84%, but no left ventricular hypertrophy.
DS = disposition (eg how the subject left the study)
EX = exposure domain - used for test drug in clinical trial
EG = ECG findings
IE = inclusion / exclusion exceptions
SU = substance use - used for additional OTC and drug-containing products the subject takes
QS = questionnaires (e.g. survey instruments)
SC = Subject characteristics
VS = vital signs
Medical School Hospital with symptoms of dizziness and orthostatic intolerance.
 started on a once daily dose of valsartan 80 mg for hypertension.



 ies were detected.

, serum creatinine 84.0 mumol/l and urinary protein 2+.
stolic, and the patient complained of dizziness (Figure 1a); orthostatic hypotension was diagnosed.
s was relieved, and the dose of atenolol was gradually increased.
 age supine BP (decreased from 173/93 to 147/82 mm Hg) and pulse rate (PR – decreased from 100 to 67 bpm) without any symptoms.
121/67 mm Hg).
 nd PR (170/96 mm Hg, PR 93 bpm on 19 April; 149/85 mm Hg, PR 70 bpm on 13 July) and flattening of the circadian BP pattern.

increase of PR in phase II and overshoot of BP in phase IV) and remained unchanged after the beta1-blocker therapy.
e photon emission computed tomography (SPECT) did not show any ischemic lesions.
ular hypertrophy.



                         total daily dose        end date of medication
              Route of administrationduration of medication start date of medication
                                      C
              CMROUTECMDOSTOT MDUR CMENDTC CMSTDTC
              IM                                                  2002
              oral                80             14-Mar-05        2004
                        numeric result in std units
             Character result      standard
             LBSTRESC   LBSTRESN   LBSTRESU
                               8.6 %
                              12.1 mM
                                84 uM
             2+



                        standard date            derived
             numeric result in std units of examinationvalue flag
             PESTRESN   PESTRESU     PEDTC       PEDRVFL
                    50 mm Hg          19-Apr-05
                    27 mm Hg          19-Apr-05
                   170 mm Hg          19-Apr-05
                    96 mm Hg          19-Apr-05
                    93 bpm            19-Apr-05
                   147 mm Hg          20-Apr-05
                    82 mm Hg          20-Apr-05
                   173 mm Hg          20-Apr-05
                    93 mm Hg          20-Apr-05
                   100 bpm            20-Apr-05
                    67 bpm            20-Apr-05
                    65 mm Hg          20-Apr-05
                   123 mm Hg          20-Apr-05
                    67 mm Hg          20-Apr-05
                   121 mm Hg          20-Apr-05
                   149 mm Hg           13-Jul-05
                    85 mm Hg           13-Jul-05
                    70 bpm             13-Jul-05
                                                 Y
                                       13-Jul-05 Y
                                      19-Apr-05 Y



ed, and the dose of atenolol was gradually increased.


 PR in phase II and overshoot of BP in phase IV) and remained unchanged after the beta1-blocker therapy.
mission computed tomography (SPECT) did not show any ischemic lesions.
67 bpm) without any symptoms.

the circadian BP pattern.

ocker therapy.
Mocked Up Patient Data
 1. Patient Record 1, Primary Condition: Diabetes

           54-year-old man
demographics / med history with diabetes was referred to the Hypertension Clinic in Jichi Medical School Hospital with symptom
           In 2002, he started insulin therapy (Hemoglobin A1c 9 %), and in 2004, he was started on a once daily dose of valsa
medical history
           He
medical historysometimes complained of dizziness and fainting while standing.
           On
medical history13 February 2005, he fell down while riding a bicycle.
           As
medical historythe clinic BP was 84/60 mm Hg on 14 March, and the valsartan was stopped.
             He
medical history was referred to otolaryngology and neurology, but no significant abnormalities were detected.
Visit 1    On 19 April, he was referred to our Hypertension Clinic.
           Laboratory data were: hemoglobin A1c 8.6%, postprandial glucose 12.1 mmol/l, serum creatinine 84.0 mumol/l and
           During a head-up tilt test, BP decreased 50 mm Hg systolic and 27 mm Hg diastolic, and the patient complained of
            After the atenolol was started, with a dose of 6.25 mg on 20 April, the dizziness was relieved, and the dose of ateno
Visit 2    A second head-up tilt test (12 July, Figure 1b) showed improvement of the average supine BP (decreased from 173
            By contrast, the standing BP remained essentially unchanged (from 123/65 to 121/67 mm Hg).
           A second ambulatory BP monitoring showed significant reduction of sleep BP and PR (170/96 mm Hg, PR 93 bpm
           The variability (s.d.) of awake SBP/DBP was also reduced (from 18/12 to 12/8 mm Hg).
           A Valsalva maneuver showed a dysautonomic pattern (a lack of compensatory increase of PR in phase II and overs
           Although a brain MRI showed multiple cerebral and cerebellar infarctions, single photon emission computed tomogr
           Echocardiography showed a cardiac ejection fraction of 84%, but no left ventricular hypertrophy.


CM concomitant meds
                    Unique subject ID    Medication category (eg per administrationdosing
                                                                       dose units
Study ID Domain Abbreviation Reported name of drugOccurrencedosewas the question asked) frequency
STUDYID DOMAIN USUBJID CMTRT             CMCAT      CMOCCURCMDOSE CMDOSU CMDOSFREQ
MOCK     CM                 1 Insulin    blood sugarYcontrol
MOCK     CM                                         Y
                            1 Valstartan hypertension              80 mg                   1

DM = demographics
                                Site ID    age         age units gender          date of collection
STUDYID DOMAIN         USUBJID SITEID      AGE         AGEU       SEX            DMDTC
MOCK    DM                                         54 year         Clinic
                              1 Jichi Medical School, HypertensionMale            19-Apr-05

AE=adverse events (generally during the study timeline)
if we assume the symptoms are adverse effects, they might look like this:
                                              severity    is        is causes cancer, treatment
                                                                                study death)
                                 term used for AE of AEserious (eg related tostart date of AE
STUDYID DOMAIN USUBJID AETERM AESEV                       AESER     AERELNSTAESTDTC
MOCK       AE                 1 dizzyness                 N         N
MOCK       AE                 1 fainting while standing N           N
MOCK       AE                                 moderate
                              1 fell while riding bicycle N         N          13-Feb-05


MH = Medical History
if the symptoms are part of the MH they might look like this
                                                 Category fordate of history collection
                                                                         start
                                   Term for medical history medical historyof medical history event
STUDYID DOMAIN USUBJID MHTERM MHCAT                          MHDTC       MHSTDTC
MOCK        MH                   1 Diabetes Diabetes 14-Mar-05
MOCK        MH                   1 Hypertension              1
                                                 Hypertension4-Mar-05
MOCK        MH                   1 dizzyness                 14-Mar-05
MOCK        MH                   1 fainting while standing 14-Mar-05
MOCK        MH                   1 fell while riding bicycle 14-Mar-05 13-Feb-05
MOCK       MH                   1                Blood pressure
                                    orthostatic intolerance 14-Mar-05
MOCK       MH                   1                hypotension14-Mar-05 14-Mar-05
                                    Blood pressure
MOCK       MH                   1                Nerve / stroke
                                                             14-Mar-05
                                    Normal neurological examevaluation
MOCK       MH                   1                Head and neck
                                                             14-Mar-05
                                    Normal otolaryngology exam


LB = Lab test results
                                              short name test test
                                    specimen ID                                   lab test original units
                                                          for name category fororiginal result
STUDYID    DOMAIN       USUBJID     LBREFID LBTESTCDLBTEST LBCAT                 LBORRES LBORRESU
MOCK       LB                  1    1A        HGA1C                    A1C
                                                         HemoglobinHematology            8.6 %
MOCK       LB                  1    1B        GLUC       Glucose Clinical chemistry 12.1 mmol/L
MOCK       LB                  1    1B        CREAT                              84.0
                                                         creatinine Clinical chemistry       mumol/L
MOCK       LB                  1    1C        TPRO       total proteinUrinalysis 2+


PE = Physical exam
                                               test name                   lab test original units haracter result
                                    body system examinedcategory fororiginal result              C
STUDYID    DOMAIN       USUBJID     PETESTCD   PETEST PECAT               PEORRES PEORRESU       PESTRESC
MOCK       PE                  1                             test; systolic        50 mm Hg
                                    Tilt-SYSBPHead-up tiltVasculature blood pressure
MOCK       PE                  1               Head-up tiltVasculature blood27 mm Hg
                                    Tilt- DIASBP             test; diastolic        pressure
MOCK       PE                  1    Sleep-DIABP             Vasculature
                                               sleep diastolic blood pressure 170 mm Hg
MOCK       PE                  1    Sleep-SYSBP             Vasculature
                                               sleep systolic blood pressure 96 mm Hg
MOCK       PE                  1                             rate
                                    Sleep-PR sleep pulseVasculature                93 bpm
MOCK       PE                  1                            Vasculature           147 mm
                                    Tilt-SYSBPSupine tilt test; systolic blood pressure Hg
MOCK       PE                  1               Supine tilt test; diastolic blood pressureHg
                                    Tilt- DIASBP            Vasculature            82 mm
MOCK       PE                  1                             test; systolic       173 mm Hg
                                    Tilt-SYSBPHead-up tiltVasculature blood pressure
MOCK       PE                  1               Head-up tiltVasculature blood93 mm Hg
                                    Tilt- DIASBP             test; diastolic        pressure
MOCK       PE                  1    Tilt-BP                  blood pressure 100 bpm
                                               Head-up tiltVasculature
MOCK       PE                  1    Tilt-BP                 Vasculature
                                               Supine tilt-blood pressure          67 bpm
MOCK       PE                  1               Standing Vasculature
                                    Standing DIASBP diastolic blood pressure mm Hg 65
MOCK       PE                  1               Standing systolic blood pressure mm Hg
                                    Standing SYSBP          Vasculature           123
MOCK       PE                  1               Standing Vasculature
                                    Standing DIASBP diastolic blood pressure mm Hg 67
MOCK       PE                  1               Standing systolic blood pressure mm Hg
                                    Standing SYSBP          Vasculature           121
MOCK       PE                  1    Sleep-DIABP             Vasculature
                                               sleep diastolic blood pressure 149 mm Hg
MOCK       PE                  1    Sleep-SYSBP             Vasculature
                                               sleep systolic blood pressure 85 mm Hg
MOCK       PE                  1                             rate
                                    Sleep-PR sleep pulseVasculature                70 bpm
MOCK       PE                  1    CircadianBP                           flattened
                                               circadian blood pressure pattern                  flattened
MOCK       PE                  1    VAR-SBP/DBP                                 8-Dec
                                               Variability (s.d.) of awake SBP/DBP                     8-Dec
MOCK       PE                  1    VAR-SBP/DBP                           18/12
                                               Variability (s.d.) of awake SBP/DBP               18/12


diagnosis: orthostatic hypotension 20 April 05
 After the atenolol was started, with a dose of 6.25 mg on 20 April, the dizziness was relieved, and the dose of atenolol was gra


A Valsalva maneuver showed a dysautonomic pattern (a lack of compensatory increase of PR in phase II and overshoot of BP
Although a brain MRI showed multiple cerebral and cerebellar infarctions, single photon emission computed tomography (SPEC
Echocardiography showed a cardiac ejection fraction of 84%, but no left ventricular hypertrophy.
DS = disposition (eg how the subject left the study)
EX = exposure domain - used for test drug in clinical trial
EG = ECG findings
IE = inclusion / exclusion exceptions
SU = substance use - used for additional OTC and drug-containing products the subject takes
QS = questionnaires (e.g. survey instruments)
SC = Subject characteristics
VS = vital signs
Medical School Hospital with symptoms of dizziness and orthostatic intolerance.
 started on a once daily dose of valsartan 80 mg for hypertension.



 ies were detected.

, serum creatinine 84.0 mumol/l and urinary protein 2+.
stolic, and the patient complained of dizziness (Figure 1a); orthostatic hypotension was diagnosed.
s was relieved, and the dose of atenolol was gradually increased.
 age supine BP (decreased from 173/93 to 147/82 mm Hg) and pulse rate (PR – decreased from 100 to 67 bpm) without any symptoms.
121/67 mm Hg).
 nd PR (170/96 mm Hg, PR 93 bpm on 19 April; 149/85 mm Hg, PR 70 bpm on 13 July) and flattening of the circadian BP pattern.

increase of PR in phase II and overshoot of BP in phase IV) and remained unchanged after the beta1-blocker therapy.
e photon emission computed tomography (SPECT) did not show any ischemic lesions.
ular hypertrophy.



                         total daily dose        end date of medication
              Route of administrationduration of medication start date of medication
                                      C
              CMROUTECMDOSTOT MDUR CMENDTC CMSTDTC
              IM                                                  2002
              oral                80             14-Mar-05        2004
                        numeric result in std units
             Character result      standard
             LBSTRESC   LBSTRESN   LBSTRESU
                               8.6 %
                              12.1 mM
                                84 uM
             2+



                        standard date            derived
             numeric result in std units of examinationvalue flag
             PESTRESN   PESTRESU     PEDTC       PEDRVFL
                    50 mm Hg          19-Apr-05
                    27 mm Hg          19-Apr-05
                   170 mm Hg          19-Apr-05
                    96 mm Hg          19-Apr-05
                    93 bpm            19-Apr-05
                   147 mm Hg          20-Apr-05
                    82 mm Hg          20-Apr-05
                   173 mm Hg          20-Apr-05
                    93 mm Hg          20-Apr-05
                   100 bpm            20-Apr-05
                    67 bpm            20-Apr-05
                    65 mm Hg          20-Apr-05
                   123 mm Hg          20-Apr-05
                    67 mm Hg          20-Apr-05
                   121 mm Hg          20-Apr-05
                   149 mm Hg           13-Jul-05
                    85 mm Hg           13-Jul-05
                    70 bpm             13-Jul-05
                                                 Y
                                       13-Jul-05 Y
                                      19-Apr-05 Y



ed, and the dose of atenolol was gradually increased.


 PR in phase II and overshoot of BP in phase IV) and remained unchanged after the beta1-blocker therapy.
mission computed tomography (SPECT) did not show any ischemic lesions.
67 bpm) without any symptoms.

the circadian BP pattern.

ocker therapy.

				
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posted:11/23/2011
language:English
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