ADL - activities of daily living
NIH - National Institutes of Health
LLN - lower limit of normal
ULN - upper limit of normal
Inhaled corticosteroids
Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
---|---|---|
Gastro-intestinal | ||
Diarrhoea | Increase of four to six stools/day over baseline | 2 (or higher) |
Nausea | Oral intake decreased without significant weight loss, dehydration or malnutrition | 2 (or higher) |
Weight gain | ≥ 20% weight gain from baseline | 3 (or higher) |
Nervous system - past psychiatric history not a contraindication | ||
Anxiety | Moderate symptoms; limiting instrumental ADL | 2 (or higher) |
Headaches | Moderate pain; limiting instrumental ADL | 2 (or higher) |
Insomnia | Moderate difficulty in falling asleep, staying asleep or waking up early | 2 (or higher) |
Mood alteration | Moderate mood alteration; limiting instrumental ADL | 2 (or higher) |
Dermatological | ||
Rash | Macules, papules, urticaria or exanthem, with or without associated symptoms, covering > 30% of body surface area; limiting self care ADL | 3 (or higher) |
Purpura/bruising | Combined area of lesion covering 10 – 30% body surface area; bleeding with trauma | 2 (or higher) |
Endocrine | ||
Adrenal insufficiency/suppression | Moderate symptoms; medical intervention indicated | 2 (or higher) |
Cushingoid | Moderate symptoms; medical intervention indicated | 2 (or higher) |
Hyperglycaemia | Fasting glucose value > 8.9 mmol/L | 2 (or higher) |
Ocular | ||
Cataracts | Symptomatic; moderate decrease in visual acuity (20/40 or better) | 2 (or higher) |
Glaucoma | Elevated intraocular pressure causing early visual field deficits; multiple topical or oral agents indicated; limiting instrumental ADL | 2 (or higher) |
Musculoskeletal | ||
Growth suppression | Reduction in growth velocity by 10-29% ideally measured over the period of a year | 1 (or higher) |
Myalgia/cramp | Moderate pain: limiting instrumental ADL | 2 (or higher) |
Osteoporosis | BMD t-score < -2.5; loss of height < 2cm; anti-osteoporotic therapy indicated; limiting instrumental ADL | 2 (or higher) |
Respiratory | ||
Bronchospasm (paradoxical) | Symptomatic; medical intervention indicated; limiting instrumental ADL | 2 (or higher) |
Cough | Severe symptoms; limiting self care ADL | 3 (or higher) |
Epistaxis | Moderate symptoms; medical intervention indicated (e.g. nasal packing, cauterisation, topical vasoconstrictors) | 2 (or higher) |
Hoarseness | Moderate or persistent voice changes; may require occasional repetition but understandable on telephone; medical evaluation indicated | 2 (or higher) |
Miscellaneous | ||
Anaphylaxis/Hypersensitivity | Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy related oedema / angioedema; hypotension | 3 (or higher) |
Inhaled beta-2 agonists
Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade |
---|---|---|
Gastro-intestinal | ||
Diarrhoea | Increase of four to six stools/day over baseline | 2 (or higher) |
Nausea | Oral intake decreased without significant weight loss, dehydration or malnutrition | 2 (or higher) |
Vomiting | Three or more episodes (separated by five minutes) in 24 hours over baseline | 2 (or higher) |
Cardiovascular | ||
Cardiac arrhythmia | Medical intervention indicated | 3 (or higher) |
Nervous system - past psychiatric history not a contraindication | ||
Mood alteration | Moderate mood alteration; limiting instrumental ADL | 2 (or higher) |
Anxiety | Moderate symptoms; limiting instrumental ADL | 2 (or higher) |
Headaches | Moderate pain; limiting instrumental ADL | 2 (or higher) |
Insomnia | Severe difficulty in falling asleep, staying asleep or waking up early | 3 (or higher) |
Tremor | Moderate symptoms; limiting instrumental ADL | 2 (or higher) |
Dermatological | ||
Rash | Macules, papules, urticaria or exanthem, with or without associated symptoms, covering > 30% of body surface area; limiting self care ADL | 3 (or higher) |
Musculoskeletal | ||
Myalgia/cramp | Moderate pain: limiting instrumental ADL | 2 (or higher) |
Metabolism | ||
Hypokalemia | < LLN - 3.0 mmol / L; symptomatic; intervention indicated | 2 (or higher) |
Respiratory | ||
Bronchospasm (paradoxical) | Symptomatic; medical intervention indicated; limiting instrumental ADL | 2 (or higher) |
Miscellaneous | ||
Anaphylaxis/Hypersensitivity | Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy related oedema / angioedema; hypotension | 3 (or higher) |
Oral Corticosteroids
Adverse event | Brief description of minimum grade | NIH common toxicity criteria grade | |
---|---|---|---|
Gastro-intestinal | |||
Gastric irritation/ulcer | Symptomatic; altered GI function; medical intervention indicated; limiting instrumental ADL | 2 (or higher) | |
Nausea | Oral intake decreased without significant weight loss, dehydration or malnutrition | 2 (or higher) | |
Vomiting | Three or more episodes (separated by five minutes) in 24 hours over baseline | 2 (or higher) | |
Weight gain | ≥ 20% weight gain from baseline | 3 (or higher) | |
Cardiovascular | |||
Hypertension | Stage 2 hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg); requiring medical intervention; more intensive therapy than previously used | 3 (or higher) | |
Fluid retention | Symptomatic; limiting function, unresponsive to therapy or requiring drug discontinuation | 3 (or higher) | |
Heart failure | Severe with symptoms at rest or with minimal activity or exertion; intervention indicated | 3 (or higher) | |
Nervous system - past psychiatric history not a contraindication | |||
Insomnia | Severe difficulty in falling asleep, staying asleep or waking up early | 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 symptoms; limiting self care ADL | 3 (or higher) | |
Dermatological | |||
Acne/dermatological conditions | Severe | 3 (or higher) | |
Purpura/bruising | Combined area of lesion covering 10 – 30% body surface area; bleeding with trauma | 2 (or higher) | |
Impaired healing | Requiring medical management | 2 (or higher) | |
Laboratory | |||
Hypertriglyceridemia | < 5.7 mmol / L | 3 (or higher) | |
Hypokalemia | < 3.0 mmol / L; hospitalisation indicated | 3 (or higher) | |
Endocrine | |||
Glucose intolerance | Symptomatic; diet modification or oral agent indicated | 2 (or higher) | |
Hyperglycaemia | Fasting glucose value > 8.9 mmol / L | 2 (or higher) | |
Disordered menstruation | Very irregular over pre-treatment | 2 (or higher) | |
Ocular | |||
Cataracts | Symptomatic with marked decrease in visual acuity (worse than 20/40 but better than 20/200); operative intervention indicated (eg cataract surgery) | 3 (or higher) | |
Glaucoma | Elevated intraocular pressure causing early visual field deficits; multiple topical or oral agents indicated; limiting instrumental ADL | 2 (or higher) | |
Musculoskeletal | |||
Osteoporosis or fracture | Symptomatic, interfering with ADL | ||
Avascular necrosis | Symptomatic; limiting instrumental ADL | 2 (or higher) | |
Myopathy | Symptomatic; evident on physical exam; limiting instrumental ADL | 2 (or higher) | |
Infections and infestations | Severe or medically significant but not immediately life threatening; limiting self-care ADL | 3 (or higher) | |
Miscellaneous | |||
Immunosuppression | Severe; requiring treatment withdrawal |