Severe allergic asthma toxicity criteria and severity descriptors

Toxicity criteria and severity descriptors for the listing of omalizumab for uncontrolled severe allergic asthma on the PBS.

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  

Page last updated: 26 May 2016

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