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Toxicity criteria and severity descriptors for Crohn disease ULN = upper limit of normal ADL = activities of daily living NIH = National Institute of Health Prednisolone Adverse event Brief description of minimum grade NIH common toxicity criteria grade Gastro-intestinal Gastric irritation/ulcer Requiring medical management 2 (or higher) Nausea Oral intake significantly reduced 2 (or higher) Vomiting Two or more episodes in 24 hours over pre- treatment 2 (or higher) Weight gain ≥ 20% weight gain 3 (or higher) Cardiovascular Hypertension Requiring therapy or more intensive therapy than previously 3 (or higher) Fluid retention Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation 3 (or higher) Central nervous system† Insomnia Frequent insomnia interfering with ADL 3 (or higher) Mood alteration Severe mood alteration interfering with ADL 3 (or higher) Personality/behavioural Disruptive to patient/family, requiring mental health intervention 3 (or higher) Restlessness Severe 3 (or higher) Dermatological Acne/dermatological conditions Severe 3 (or higher) Purpura/bruising Generalised or mucosal petechiae 3 (or higher) Impaired healing Requiring medical management 2 (or higher) Laboratory Hyperglycaemia Glucose 13.9 mmol / L or higher 3 (or higher) Hypertriglyceridaemia > 5 – 10 x ULN 3 (or higher) Hypokalaemia < 3.0 mmol / L 3 (or higher) Endocrine Cushingoid appearance Present 3 (or higher) Disordered menstruation Very irregular over pre-treatment 2 (or higher) Ocular Cataracts Symptomatic visual loss requiring treatment or interfering with function 3 (or higher) Glaucoma Increase in intraocular pressure with retinal changes 2 (or higher) Musculo-skeletal Osteoporosis/fracture Symptomatic, interfering with ADL Avascular necrosis Symptomatic, interfering with function 2 (or higher) Myopathy Symptomatic, interfering with function 2 (or higher) Miscellaneous Immuno-suppression Severe, requiring treatment withdrawal Impaired healing Symptomatic, interfering with ADL Growth retardation 1 † Past psychiatric history not a contraindication Azathioprine Adverse event Brief description of minimum grade NIH common toxicity criteria grade Haematological Leucocytes < 2 x 109 / L 3 (or higher) Haemoglobin < 80g / L 3 (or higher) Thrombocytes < 50 x 109 / L 3 (or higher) Neoplasms New malignancy Serious malignancy present 4 Gastro-intestinal Nausea Oral intake significantly reduced 2 (or higher) Vomiting Two or more episodes in 24 hours over pre- treatment 2 (or higher) Diarrhoea Increase of more than 4 stools per day over pre- treatment or incontinence 2 (or higher) Stomatitis Painful erythema, oedema or ulcers but can eat/swallow 2 (or higher) Abdominal pain Severe pain/analgesia interfering with ADL 3 (or higher) Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher) Hepatic Bilirubin > 1.5 x ULN 2 (or higher) Hepatic enzymes > 2.5 x ULN 2(or higher) Dermatological Rash Rash with associated symptoms over less than 50% of body surface 2 (or higher) Alopecia Pronounced hair loss 3 (or higher) Pulmonary Pneumonitis X-Ray changes, requiring steroids and diuretics 2 (or higher) Miscellaneous Hypersensitivity Rash, drug fever > 38O, aches etc. 2 (or higher) Immuno- suppression/atypical infection Severe/systemic infection requiring IV antibiotic/antifungal treatment or hospitalisation 3 (or higher) 2 Mercaptopurine Adverse event Brief description of minimum grade NIH common toxicity criteria grade Haematological Leucocytes < 2 x 109 / L 3 (or higher) Haemoglobin < 80g / L 3 (or higher) Thrombocytes < 50 x 109 / L 3 (or higher) Gastro-intestinal Nausea Oral intake significantly reduced 2 (or higher) Vomiting Two or more episodes in 24 hours over pre- treatment 2 (or higher) Anorexia Oral intake significantly reduced 2 (or higher) Stomatitis (oral ulcers etc) Painful erythema, oedema or ulcers but can eat/swallow 2 (or higher) Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher) Hepatic Bilirubin > 1.5 x ULN 2 (or higher) Hepatic enzymes > 2.5 x ULN 2 (or higher) Dermatological Rash Rash with associated symptoms over less than 50% of body surface 2 (or higher) Alopecia Pronounced hair loss 3 (or higher) Neoplasia Secondary malignancy (e.g. leukaemia) Present 4 Miscellaneous Hypersensitivity Rash, drug fever > 38O, arthralgia etc. 2 (or higher) Joint pain Moderate pain/analgesics, significantly interferes with function 2 (or higher) 3 Methotrexate Adverse event Brief description of minimum grade NIH common toxicity criteria grade Alimentary tract Diarrhoea Increase of more than 4 stools per day over pre- treatment or incontinence 2 (or higher) Nausea Oral intake significantly decreased and symptoms that do not respond to at least two of the following: • reduction of the methotrexate dose • folinic acid/folic acid supplementation • switching from oral dosing to intramuscular dosing • splitting the methotrexate dose over 12 hours A minimum of three doses of methotrexate should have been trialled 2 (or higher) Stomatitis Painful erythema, oedema or ulcers but able to eat/swallow 2 (or higher) Vomiting Two or more episodes in 24 hours over pre- treatment 2 (or higher) Blood Haemoglobin < 80 g/L 3 (or higher) Clinical haemorrhage Requiring transfusion 3 (or higher) Leukocytes < 2 x 109 /L 3 (or higher) Phlebitis Present 2 (or higher) Thrombocytes < 50 x 109 /L 3 (or higher) Cardiovascular Arrhythmia Symptomatic and requiring therapy 3 (or higher) Cardiac function Congestive heart failure responsive to treatment 3 (or higher) Pericardial effusion/pericarditis Pericarditis (pericardial rub, ECG changes or chest pain) 2 (or higher) Central nervous system Ataxia Mild symptoms interfering with function but not interfering with ADL 2 (or higher) Hearing Tinnitus or hearing loss not requiring treatment 2 (or higher) Incoordination Mild symptoms interfering with function but not interfering with ADL 2 (or higher) Mood alteration Moderate mood alteration interfering with function but not interfering with ADL 2 (or higher) Vision Symptomatic and interfering with function but not interfering with ADL 3 (or higher) Dermatological Alopecia Pronounced hair loss 2 (or higher) Rash Rash with associated symptoms over less than 50 % of body surface 2 (or higher) Hepatic Bilirubin > 1.5 x ULN 2 (or higher) Elevated transaminases • ALT and/or AST > 2.5 x ULN or • ALT and/or AST > 1.5 x ULN 2 (or higher) 4 on three occasions over a three month period Elevated serum alkaline phosphatase 2.5 x ULN 2 (or higher) Respiratory Pneumonitis/pulmonary infiltrates Radiographic changes and requiring steroids/diuretics 2 (or higher) Pulmonary fibrosis Requiring steroids/diuretics 2 (or higher) Cough (severe) Severe cough/coughing spasm that is poorly controlled or unresponsive to treatment. Evidence of reversal on treatment withdrawal 3 (or higher) Renal Renal impairment Creatinine clearance < 30ml / min 3 (or higher) Other Allergic reaction Urticaria, drug fever > 380C or bronchospasm 2 (or higher) Infection Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation 3 (or higher) Headaches (severe) Severe pain (requiring compound analgesics) where pain/analgesics severely interfere with ADL 3 (or higher) Nodulosis (following introduction of methotrexate therapy) Development of multiple new nodules causing significant local pressure symptoms and distress to patient 5
