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 4 to 6 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 < 2 cm; 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 4 to 6 stools/day over baseline | 2 (or higher) |
| Nausea | Oral intake decreased without significant weight loss, dehydration or malnutrition | 2 (or higher) |
| Vomiting | 3 or more episodes (separated by 5 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 | 3 or more episodes (separated by 5 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 mmHg or diastolic BP ≥ 100 mmHg); 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 | |