anti resorptive agent toxicity criteria and severity descriptors 1011 by F1A01P

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									             Anti-resorptive agent toxicity criteria and severity
                                descriptors

         ULN = upper limit of normal
         ADL = activities of daily living
         NIH = National Institute of Health

                                             Alendronate
                                                                                     NIH Common
                                                                                     Toxicity
Adverse Event                          Brief Description of minimum grade
                                                                                     Criteria
                                                                                     Grade
Gastro-intestinal
Gastritis                              Uncontrolled by appropriate out-patient       3 (or higher)
                                       medical management
Nausea                                 Oral intake significantly decreased; a        2 (or higher)
                                       minimum of three doses must be trialled
Diarrhoea                              Increase of at least 4 - 6 stools /day over   2 (or higher)
                                       pre-treatment or nocturnal stools
Dyspepsia / heartburn                  Severe                                        3 (or higher)
Dysphagia / odynophagia                Requiring soft or liquid diet                 2 (or higher)
Ulcer                                  Requiring medical management                  2 (or higher)
Pain
Headache                               Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Joint pain ( arthralgia / arthritis)   Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Myalgia / cramps                       Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Osteonecrosis                          Symptomatic; interfering with ADL             2 (or higher)
Dermatological
Rash                                   Symptomatic / generalised affecting >         3 (or higher)
                                       50% body area

                                             Denosumab
                                                                                     NIH Common
                                                                                     Toxicity
Adverse Event                          Brief Description of minimum grade
                                                                                     Criteria
                                                                                     Grade
Allergy
Allergic reaction /                    urticaria, drug fever 38°C or higher,         2 (or higher)
hypersensitivity                       and/or asymptomatic bronchospasm
Gastro-intestinal
Pancreatitis                           Abdominal pain with pancreatic enzyme         3 (or higher)
                                       elevation



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Metabolic
Hypercholesterolemia                   Rise to > 7.75 mmol/L                         2 (or higher)
Hypocalcaemia                          Corrected Calcium < 2.0 mmol/L                2 (or higher)
Pain
Joint pain ( arthralgia / arthritis)   Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Myalgia / cramps                       Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Osteonecrosis                          Symptomatic; interfering with ADL             2 (or higher)
Dermatological
Rash                                   Symptomatic / generalised affecting >         3 (or higher)
                                       50% body area
Skin infection / cellulitis            Infection requiring i.v. antibiotics          3 (or higher)

                          Etidronate plus calcium (Didrocal®)

                                                                                     NIH Common
                                                                                     Toxicity
Adverse Event                          Brief Description of minimum grade
                                                                                     Criteria
                                                                                     Grade
Gastro-intestinal
Gastritis                              Uncontrolled by appropriate out-patient       3 (or higher)
                                       medical management
Nausea                                 Oral intake significantly decreased; a        2 (or higher)
                                       minimum of three doses must be trialled
Diarrhoea                              Increase of at least 4 - 6 stools /day over   2 (or higher)
                                       pre-treatment or nocturnal stools
Pain
Headache                               Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Joint pain (arthralgia / arthritis)    Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Myalgia / cramps                       Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Osteonecrosis                          Symptomatic; interfering with ADL             2 (or higher)
Dermatological
Rash                                   Symptomatic / generalised affecting >         3 (or higher)
                                       50% body area




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                                             Raloxifene
                                                                                    NIH Common
                                                                                    Toxicity
Adverse Event                         Brief Description of minimum grade
                                                                                    Criteria
                                                                                    Grade
Endocrine
Hot flushes                           Severe, frequent, interfering with ADL        3 (or higher)
Gynaecological eg vaginitis,          Severe; interfering with ADL                  3 (or higher)
vaginal bleeding / discharge
Gastro-intestinal
Gastritis                             Uncontrolled by appropriate out-patient       3 (or higher)
                                      medical management
Nausea                                Oral intake significantly decreased; a        2 (or higher)
                                      minimum of three doses must be trialled
Diarrhoea                             Increase of at least 4 - 6 stools /day over   2 (or higher)
                                      pre-treatment or nocturnal stools
Pain
Headache                              Severe pain requiring compound                3 (or higher)
                                      analgesics and significantly interfering
                                      with ADL
Joint pain (arthralgia / arthritis)   Severe pain requiring compound                3 (or higher)
                                      analgesics and significantly interfering
                                      with ADL
Myalgia / cramps                      Severe pain requiring compound                3 (or higher)
                                      analgesics and significantly interfering
                                      with ADL
Dermatological
Rash                                  Symptomatic / generalised affecting >         3 (or higher)
                                      50% body area
Miscellaneous
Flu-like syndrome                     Severe, prolonged, requiring medical
                                      therapy
Fever                                 > 39.1 o C                                    2 (or higher)
Depression                            Severe, and interfering with ADL              3 (or higher)



                                            Risedronate
                                                                                    NIH Common
                                                                                    Toxicity
Adverse Event                         Brief Description of minimum grade
                                                                                    Criteria
                                                                                    Grade
Gastro-intestinal
Gastritis                             Uncontrolled by appropriate out-patient       3 (or higher)
                                      medical management
Nausea                                Oral intake significantly decreased; a        2 (or higher)
                                      minimum of three doses must be trialled
Diarrhoea                             Increase of at least 4 - 6 stools /day over   2 (or higher)
                                      pre-treatment or nocturnal stools
Dyspepsia / heartburn                 Severe                                        3 (or higher)
Dysphagia / odynophagia               Requiring soft or liquid diet                 2 (or higher)
Ulcer                                 Requiring medical management                  2 (or higher)

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Pain
Headache                              Severe pain requiring compound                3 (or higher)
                                      analgesics and significantly interfering
                                      with ADL
Joint pain (arthralgia / arthritis)   Severe pain requiring compound                3 (or higher)
                                      analgesics and significantly interfering
                                      with ADL
Myalgia / cramps                      Severe pain requiring compound                3 (or higher)
                                      analgesics and significantly interfering
                                      with ADL
Osteonecrosis                         Symptomatic; interfering with ADL             2 (or higher)
Dermatological
Rash                                  Symptomatic / generalised affecting >         3 (or higher)
                                      50% body area
Miscellaneous
Hypertension                          Requiring additional anti-hypertensive        3 (or higher)
                                      therapy
Dizziness                             Interfering with ADL                          2 (or higher)
Asthenia / fatigue                    Severe, loss of ability to perform some       3 (or higher)
                                      ADL

                                       Strontium ranelate
                                                                                    NIH Common
                                                                                    Toxicity
Adverse Event                         Brief Description of minimum grade
                                                                                    Criteria
                                                                                    Grade
Gastro-intestinal
Nausea                                Oral intake significantly decreased; a        2 (or higher)
                                      minimum of three doses must be trialled
Diarrhoea                             Increase of at least 4 - 6 stools /day over   2 (or higher)
                                      pre-treatment or nocturnal stools
Pain
Headache                              Severe pain requiring compound                3 (or higher)
                                      analgesics and significantly interfering
                                      with ADL
Dermatological
Hyper-sensitivity                     Drug rash with systemic symptoms
Erythema multiform / Stevens-         Severe, generalised or mucosal                3 (or higher)
Johnson syndrome                      ulceration
Rash                                  Symptomatic / generalised affecting >         3 (or higher)
                                      50% body area
Cardio-vascular
Venous thrombo-embolism eg            Requiring anti-coagulation                    3 (or higher)
deep vein thrombosis (DVT),
pulmonary embolism (PE) etc




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                                          Zoledronic acid

                                                                                     NIH Common
                                                                                     Toxicity
Adverse Event                          Brief Description of minimum grade
                                                                                     Criteria
                                                                                     Grade
Gastro-intestinal
Gastritis                              Uncontrolled by appropriate out-patient       3 (or higher)
                                       medical management
Nausea                                 Oral intake significantly decreased; a        2 (or higher)
                                       minimum of three doses must be trialled
Diarrhoea                              Increase of at least 4 - 6 stools /day over   2 (or higher)
                                       pre-treatment or nocturnal stools
Stomatitis                             Erythema, odema or swelling requiring         3 (or higher)
                                       i.v.hydration
Constipation                           Requiring manual evacuation and/or            3 (or higher)
                                       enema
Dyspepsia/heartburn                    Severe                                        3 (or higher)
Dysphagia/odynophagia                  Requiring soft or liquid diet                 2 (or higher)
Ulcer                                  Requiring medical management                  2 (or higher)
Pain
Abdominal pain                         Moderate requiring analgesics and
                                       affecting ADL
Headache                               Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Joint pain ( arthralgia / arthritis)   Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Myalgia / cramps                       Severe pain requiring compound                3 (or higher)
                                       analgesics and significantly interfering
                                       with ADL
Osteonecrosis                          Symptomatic; interfering with ADL             2 (or higher)
Dermatological
Rash                                   Symptomatic / generalised affecting >         3 (or higher)
                                       50% body area
Hypersensitivity                       Drug rash with systemic symptoms              See c/i
Miscellaneous
Hypertension                           Requiring additional antihypertensive         3 (or higher)
                                       therapy
Hypotension                            Requiring medical therapy and sustained       3 (or higher)
                                       medical attention, no permanent effect
Anaemia                                Hb < 100 g/L                                  2 (or higher)
Creatinine                             Change to > 1.5 x ULN                         2 (or higher)
Dizziness                              Interfering with ADL                          2 (or higher)
Asthenia/fatigue                       Severe, loss of ability to perform some       3 (or higher)
                                       functions
Flu-like syndrome                      Severe, prolonged, requiring medical
                                       therapy




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