Use the following toxicity and severity descriptors with the authority application when demonstrating a patient’s intolerance to NSAID treatment.
| Adverse event | Brief description of minimum grade | National Institutes of Health common toxicity criteria grade |
|---|---|---|
| Blood or bone marrow | ||
| Anaemia | Haemoglobin <80 g per L | 3 (or higher) |
| Haemolysis | Evidence of red cell destruction and >20 g per L drop in haemoglobin, no transfusion required | 2 (or higher) |
| Leukopaenia | Total white cell count < 3 × 109 per L | 2 (or higher) |
| Neutropaenia | Neutrophils <1.0 × 109 per L | 3 (or higher) |
| Thrombocytopaenia | Platelets <50 × 109 per L | 3 (or higher) |
| Cardiovascular | ||
| Arrhythmia | Symptomatic and requiring therapy | 3 (or higher) |
| Cardiac left ventricle function | Congestive cardiac failure responsive to treatment | 3 (or higher) |
| Hypertension | Recurrent or persistent rise of >20 mmHg diastolic blood pressure or rise to >150/90 on 2 occasions if blood pressure previously normal | 2 (or higher) |
| Myocardial ischaemia or infarction | Unstable angina or myocardial infarction | 3 (or higher) |
| Oedema | Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation | 3 (or higher) |
| Coagulation | ||
| Prothrombin time | Prothrombin time >2 × upper limit of normal | 3 (or higher) |
| Dermatology or skin | ||
| Alopecia | Pronounced hair loss | 2 (or higher) |
| Photosensitivity | Painful erythema or bullae | 2 (or higher) |
| Pruritis | Intense or widespread and poorly controlled despite treatment | 3 (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 surface | 2 (or higher) |
| Urticaria | Requiring topical, oral or IV medication for <24 hours | 2 (or higher) |
| Gastrointestinal | ||
| Abdominal pain | Moderate pain, interfering with function | 2 (or higher) |
| Anorexia | Oral intake significantly decreased | 2 (or higher) |
| Constipation | Requiring use of laxatives and enemas | 3 (or higher) |
| Diarrhoea | Increase of 4-6 stools per day over pretreatment | 2 (or higher) |
| Dyspepsia | Moderate or severe, unresponsive to standard therapy, recurs on rechallenge | 2 (or higher) |
| Nausea | Oral intake significantly decreased | 2 (or higher) |
| Pancreatitis | Abdominal pain with pancreatic enzyme elevation | 3 (or higher) |
| Peptic ulcer | Requiring medical management | 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) |
| Haemorrhage | ||
| Melena or gastrointestinal bleeding | Requiring transfusion | 3 (or higher) |
| Purpura | Generalised purpura | 3 (or higher) |
| Hepatic | ||
| Bilirubin | >1.5 × upper limit of normal | 2 (or higher) |
| Transaminases | Alanine aminotransferase or aspartate aminotransferase >2.5 × upper limit of normal or alanine aminotransferase or aspartate aminotransferase >1.5 × upper limit of normal on 3 occasions over a 3-month period | 2 (or higher) |
| Neurology or senses | ||
| Central nervous system cerebrovascular ischaemia | Transient ischaemic attack or cerebrovascular accident | 3 (or higher) |
| 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 interfering with activities of daily living | 3 (or higher) |
| Inner ear or hearing | Tinnitus or hearing loss not requiring hearing aid or treatment | 2 (or higher) |
| Insomnia | Frequent difficulty sleeping, interfering with activities of daily living | 3 (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) |
| Vertigo | Interfering with activities of daily living | 3 (or higher) |
| Vision | Symptomatic and interfering with function but not interfering with activities of daily living | 2 (or higher) |
| Pulmonary | ||
| Asthma | Moderate | 2 (or higher) |
| 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) |
| Renal | ||
| Haematuria | Macroscopic haematuria | 2 (or higher) |
| Hyperkalaemia | >6.0 mmol per L | 3 (or higher) |
| Proteinuria | >1.0 g per 24 hours, elevated urine protein:creatinine ratios >100 mg per mmol, dipstick protein ++ or greater, confirmed on 2 separate occasions | 2 (or higher) |
| Renal impairment | Creatinine >1.5 upper limit of normal or creatinine clearance <30 mL per min | 2 (or higher) |
| Other | ||
| Allergic reaction or hypersensitivity | Urticaria, drug fever >38 °C or bronchospasm | 2 (or higher) |
| Fatigue, malaise | Severe, loss of ability to perform some activities | 3 (or higher) |
| Infection | Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation | 3 (or higher) |