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ADL - activities of daily living
NIH - National Institutes of Health
LLN - lower limit of normal
ULN - upper limit of normal
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 | 2 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 - past psychiatric history not a contraindication | ||
| 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) |
| Hypertriglyceridemia | > 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) |
| Musculoskeletal | ||
| 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 | 3 (or higher) |
| Impaired healing | Symptomatic, interfering with ADL | |
| Growth retardation | ||
Azathioprine
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Haematological | ||
| Leucocytes | < 2 x 109 / L | 3 (or higher) |
| Haemoglobin | < 80 g/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 | 2 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 > 380, aches etc. | 2 (or higher) |
| Immuno-suppression/atypical infection | Severe/systemic infection requiring IV antibiotic/antifungal treatment or hospitalisation | 3 (or higher) |
Mercaptopurine
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Haematological | ||
| Leucocytes | < 2 x 109 / L | 3 (or higher) |
| Haemoglobin | < 80 g/ L | 3 (or higher) |
| Thrombocytes | < 50 x 109 / L | 3 (or higher) |
| Gastro-intestinal | ||
| Nausea | Oral intake significantly reduced | 2 (or higher) |
| Vomiting | 2 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 > 38°C, arthralgia etc. | 2 (or higher) |
| Joint pain | Moderate pain/analgesics, significantly interferes with function | 2 (or higher) |
5-aminosalicylates
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Blood / Bone Marrow | ||
| Anaemia | Haemoglobin < 80 g/L | 3 (or higher) |
| Leukopenia | Total WCC < 3 x 109 / L | 2 (or higher) |
| Thrombocytopenia | Platelets < 50 x 109 / L | 3 (or higher) |
| Neutropenia | Total neutrophils < 1.0 x 109 / L | 3 (or higher) |
| Dermatology / Skin | ||
| Alopecia | Pronounced hair loss | 2 (or higher) |
| Rash / desquamation | Scattered macular or papular eruption or erythema with pruritus or other associated symptoms covering < 50% of body surface or localised desquamation or other lesions covering < 50% of body | 2 (or higher) |
| Gastrointestinal | ||
| Diarrhoea | Increase of 4-6 stools/day over pre-treatment | 2 (or higher) |
| Nausea | Oral intake significantly decreased | 2 (or higher) |
| Pancreatitis | Abdominal pain with pancreatic enzyme elevation | 3 (or higher) |
| Stomatitis | Painful erythema, oedema or ulcers but able to eat or swallow | 2 (or higher) |
| Vomiting | 2 or more episodes per 24 hours over pre-treatment | 2 (or higher) |
| Hepatic | ||
| Bilirubin | > 1.5 x ULN | 2 (or higher) |
| Transaminases | ALT and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a 3-month period | 2 (or higher) |
| ^Serum alkaline phosphatase | 2.5 x ULN | 2 (or higher) |
| Neurology / Senses | ||
| Headaches (severe) | Severe pain: pain or analgesics severely interfere with activities of daily living | 3 (or higher) |
| Hearing | Tinnitus or hearing loss not requiring hearing aid or treatment | 2 (or higher) |
| Mood alteration | Moderate mood alteration interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Neuropathy - Sensory | Objective sensory loss or paraesthesia interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Seizure(s) | Seizures in which consciousness is altered | 3 (or higher) |
| Pulmonary | ||
| Cough (severe) | Severe cough or coughing spasm, poor control or unresponsive to treatment. Evidence of reversal on cessation of treatment. | 3 (or higher) |
| Pneumonitis/pulmonary infiltrates | Radiographic changes, Respiratory Function Test abnormalities and requiring steroids or diuretics | 2 (or higher) |
| Renal | ||
| Haematuria | Macroscopic (or dipstick +++) confirmed on 2 separate occasions | 2 (or higher) |
| Proteinuria | > 1.0g/24 hours, elevated urine protein/creatinine ratios, (dipstick protein ++ or greater), confirmed on 2 separate occasions | 2 (or higher) |
| Renal impairment | Creatinine > 1.5 ULN or creatinine clearance < 30 mL/min | 2 (or higher) |
| Other | ||
| Allergic reaction | Urticaria, drug fever > 38°C and / or bronchospasm | 2 (or higher) |
| Fever (in the absence of neutropenia) | Body temp > 39°C (oral or tympanic) | 2 (or higher) |