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ALT - alanine aminotransferase
AST - aspartate aminotransferase
BP - blood pressure
ECG - electrocardiogram
IV - intravenous
NIH - National Institutes of Health
ULN - upper limit of normal
WCC - white cell count
Prednisolone
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Gastrointestinal | ||
| Gastric irritation or 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 is not a contraindication | ||
| Insomnia | Frequent insomnia interfering with activities of daily living | 3 (or higher) |
| Mood alteration | Severe mood alteration interfering with activities of daily living | 3 (or higher) |
| Personality or behaviour | Disruptive to patient or family, requiring mental health intervention | 3 (or higher) |
| Restlessness | Severe | 3 (or higher) |
| Dermatological | ||
| Acne or dermatological conditions | Severe | 3 (or higher) |
| Purpura or bruising | Generalised or mucosal petechiae | 3 (or higher) |
| Impaired healing | Requiring medical management | 2 (or higher) |
| Laboratory | ||
| Hyperglycaemia | Glucose 13.9 mmol per L or higher | 3 (or higher) |
| Hypertriglyceridaemia | > 5-10 x upper limit of normal | 3 (or higher) |
| Hypokalaemia | < 3.0 mmol per 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 or fracture | Symptomatic, interfering with activities of daily living | |
| Avascular necrosis | Symptomatic, interfering with function | 2 (or higher) |
| Myopathy | Symptomatic, interfering with function | 2 (or higher) |
| Miscellaneous | ||
| Immunosuppression | Severe, requiring treatment withdrawal | |
| Impaired healing | Symptomatic, interfering with activities of daily living | |
| Growth retardation | ||
Hydroxychloroquine
Only valid for adult patients.
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Blood or bone marrow | ||
| Anaemia | Haemoglobin < 80 g per L | 3 (or higher) |
| Leukopenia | Total WCC < 3 x 109 per L | 2 (or higher) |
| Thrombocytopenia | Platelets < 50 x 109 per L | 3 (or higher) |
| Neutropenia | Total neutrophils < 1.0 x 109 per L | 3 (or higher) |
| Dermatology or skin | ||
| Alopecia | Pronounced hair loss | 2 (or higher) |
| Rash or desquamation | Scattered macular or papular eruption or erythema with pruritis 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 per day over pre-treatment | 2 (or higher) |
| Nausea | Oral intake significantly decreased | 2 (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 or AST > 2.5 x ULN or ALT or AST > 1.5 x ULN on 3 occasions over a 3-month period | 2 (or higher) |
| Serum alkaline phosphatase | 2.5 x ULN | 2 (or higher) |
| Musculoskeletal | ||
| Muscle weakness | Symptomatic and interfering with function | 2 (or higher) |
| Neurology or 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) |
| Neuropathy - motor | Objective weakness 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) |
| Vision | Symptomatic and interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Vision - cornea or retina | Symptomatic corneal or retinal changes present | 1 (or higher) |
| Other | ||
| Allergic reaction | Urticaria, drug fever > 38 °C or bronchospasm | 2 (or higher) |
Methotrexate
Only valid for adult patients.
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Blood or bone marrow | ||
| Anaemia | Haemoglobin < 80 g per L | 3 (or higher) |
| Leukopenia | Total WCC < 3 x 109 per L | 2 (or higher) |
| Thrombocytopenia | Platelets < 50 x 109 per L | 3 (or higher) |
| Neutropenia | Total neutrophils < 1.0 x 109 per L | 3 (or higher) |
| Cardiovascular | ||
| Pericardial effusion or pericarditis | Pericarditis (pericardial rub, ECG changes or chest pain) | 2 (or higher) |
| Thrombosis or embolism | Requiring anticoagulant therapy | 3 (or higher) |
| Dermatology or skin | ||
| Alopecia | Pronounced hair loss | 2 (or higher) |
| Rash or desquamation | Scattered macular or papular eruption or erythema with pruritis 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 per day over pre-treatment | 2 (or higher) |
| Nausea | Oral intake significantly decreased, and symptoms don't improve with at least 2 of the following measures:
A minimum of 3 doses of methotrexate should have been trialled | 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 or AST > 2.5 x ULN or ALT or AST > 1.5 x ULN on 3 occasions over a 3-month period | 2 (or higher) |
| Serum alkaline phosphatase | 2.5 x ULN | 2 (or higher) |
| Musculoskeletal | ||
| Osteonecrosis (avascular necrosis) | Symptomatic and interfering with function | 2 (or higher) |
| Osteoporosis | Symptomatic and requiring treatment | 3 (or higher) |
| Neurology or senses | ||
| Decreased level of consciousness | Somnolence or sedation interfering with function but not interfering with activities of daily living | 2 (or higher) |
| 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) |
| Seizure(s) | Seizures in which consciousness is altered | 3 (or higher) |
| Vision | Symptomatic and interfering with function but not interfering with activities of daily living | 2 (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 or pulmonary infiltrates | Radiographic changes, respiratory function test abnormalities and requiring steroids or diuretics | 2 (or higher) |
| Pulmonary fibrosis | Respiratory function test abnormalities and requiring steroids or diuretics | 2 (or higher) |
| Pulmonary symptoms - new or worsening (probable drug-induced pneumonitis) | Development of syndrome consistent with drug-induced pneumonitis (for example, cough, dyspnoea, fever, hypoxaemia) with lung infiltrates on imaging (refer Searles McKendry criteria) | |
| Renal | ||
| Haematuria | Macroscopic (or dipstick +++) confirmed on 2 separate occasions | 2 (or higher) |
| Renal impairment | Creatinine > 1.5 ULN or creatinine clearance < 30 mL per min | 2 (or higher) |
| Other | ||
| Allergic reaction | Urticaria, drug fever > 38 °C or bronchospasm | 2 (or higher) |
| Fatigue, malaise | Severe, loss of ability to perform some activities | 3 (or higher) |
| Fever (in the absence of neutropenia) | Body temp > 39 °C (oral or tympanic) | 2 (or higher) |
| Infection | Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation | 3 (or higher) |
| Nodulosis (following introduction of methotrexate therapy) | Development of multiple new nodules causing significant local pressure symptoms and distress to patient | |
| Secondary malignancy | Secondary malignancy present | 4 |
Azathioprine
Only valid for adult patients.
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Blood or bone marrow | ||
| Anaemia | Haemoglobin < 80 g per L | 3 (or higher) |
| Leukopenia | Total WCC < 3 x 109 per L | 2 (or higher) |
| Thrombocytopenia | Platelets < 50 x 109 per L | 3 (or higher) |
| Neutropenia | Total neutrophils < 1.0 x 109 per L | 3 (or higher) |
| Dermatology or skin | ||
| Alopecia | Pronounced hair loss | 2 (or higher) |
| Rash or desquamation | Scattered macular or papular eruption or erythema with pruritis 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 per 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 or AST > 2.5 x ULN or ALT or AST > 1.5 x ULN on 3 occasions over a 3-month period | 2 (or higher) |
| Ç Serum alkaline phosphatase | 2.5 x ULN | 2 (or higher) |
| Neurology or senses | ||
| Headaches (severe) | Severe pain; pain or analgesics severely interfere with activities of daily living | 3 (or higher) |
| Pulmonary | ||
| Pneumonitis or pulmonary infiltrates | Radiographic changes, respiratory function test abnormalities and requiring steroids or diuretics | 2 (or higher) |
| Other | ||
| Allergic reaction | Urticaria, drug fever > 38 °C or bronchospasm | 2 (or higher) |
| Fatigue, malaise | Severe, loss of ability to perform some activities | 3 (or higher) |
| Fever (in the absence of neutropenia) | Body temp > 39 °C (oral or tympanic) | 2 (or higher) |
| Infection | Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation | 3 (or higher) |
| Secondary malignancy | Secondary malignancy present | 4 |
Mycophenolate
| Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
|---|---|---|
| Gastrointestinal | ||
| Gastric irritation or 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) |
| Diarrhoea | Increase of more than 4 stools per day over pre-treatment, or incontinence | 2 (or higher) |
| Central nervous system | ||
| Altered mental status | Confusion, memory impairment, lethargy or somnolence causing inability to perform usual social and functional activities | 3 (or higher) |
| Dizziness | Moderate unsteadiness; limiting activities of daily living | 2 (or higher) |
| Tremor | Moderate symptoms; limiting activities of daily living | 2 (or higher) |
| Insomnia | Frequent insomnia interfering with activities of daily living | 3 (or higher) |
| Dermatological | ||
| Infection | Oral intervention indicated (e.g. antibiotic, antifungal, antiviral) | 2 (or higher) |
| Rash | Rash with associated symptoms over less than 50% of body surface | 2 (or higher) |
| Blood or bone marrow | ||
| Anaemia | Haemoglobin < 80 g per L | 3 (or higher) |
| Leukopenia | Total WCC < 3 x 109 per L | 2 (or higher) |
| Thrombocytopenia | Platelets < 50 x 109 per L | 3 (or higher) |
| Pulmonary | ||
| Infection | Oral intervention indicated (e.g. antibiotic, antifungal, antiviral) | 2 (or higher) |
| Body as a whole | ||
| Sepsis | Life-threatening consequences | 4 |
| Infection | Oral intervention indicated (e.g. antibiotic, antifungal, antiviral) | 2 (or higher) |
| Headache | Moderate pain; limiting activities of daily living | 2 (or higher) |
| Fever | Body temp > 39 °C (oral or tympanic) | 2 (or higher) |
| Abdominal pain | Severe pain, analgesia interfering with activities of daily living | 3 (or higher) |
| Neoplasm | New malignancy present | 4 |