Ulcerative colitis toxicity criteria and severity descriptors

Toxicity criteria and severity descriptors for the listing of infliximab for ulcerative colitis on the PBS.

ADL - activities of daily living
NIH - National Institutes of Health
LLN - lower limit of normal
ULN - upper limit of normal

Prednisolone

Adverse event Brief description of minimum grade NIH common toxicity criteria grade
Gastro-intestinal
Gastric irritation/ulcer Requiring medical management 2 (or higher)
Nausea Oral intake significantly reduced 2 (or higher)
Vomiting Two 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 not a contraindication
Insomnia Frequent insomnia interfering with ADL 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 3 (or higher)
Dermatological
Acne/dermatological conditions Severe 3 (or higher)
Purpura/bruising Generalised or mucosal petechiae 3 (or higher)
Impaired healing Requiring medical management 2 (or higher)
Laboratory
Hyperglycaemia Glucose 13.9 mmol / L or higher 3 (or higher)
Hypertriglyceridemia > 5 – 10 x ULN 3 (or higher)
Hypokalaemia < 3.0 mmol / 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/fracture Symptomatic, interfering with ADL
Avascular necrosis Symptomatic, interfering with function 2 (or higher)
Myopathy Symptomatic, interfering with function 2 (or higher)
Miscellaneous
Immuno-suppression Severe, requiring treatment withdrawal 3 (or higher)
Impaired healing Symptomatic, interfering with ADL
Growth retardation

Azathioprine

Adverse event Brief description of minimum grade NIH common toxicity criteria grade
Haematological
Leucocytes < 2 x 109 / L 3 (or higher)
Haemoglobin < 80g / L 3 (or higher)
Thrombocytes < 50 x 109 / L 3 (or higher)
Neoplasms
New malignancy Serious malignancy present 4
Gastro-intestinal
Nausea Oral intake significantly reduced 2 (or higher)
Vomiting Two 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)
Stomatitis Painful erythema, oedema or ulcers but can eat/swallow 2 (or higher)
Abdominal pain Severe pain/analgesia interfering with ADL 3 (or higher)
Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher)
Hepatic  
Bilirubin > 1.5 x ULN 2 (or higher)
Hepatic enzymes > 2.5 x ULN 2(or higher)
Dermatological
Rash Rash with associated symptoms over less than 50% of body surface 2 (or higher)
Alopecia Pronounced hair loss 3 (or higher)
Pulmonary  
Pneumonitis X-Ray changes, requiring steroids and diuretics 2 (or higher)
Miscellaneous
Hypersensitivity Rash, drug fever > 380, aches etc. 2 (or higher)
Immuno-suppression/atypical infection Severe/systemic infection requiring IV antibiotic/antifungal treatment or hospitalisation 3 (or higher)

Mercaptopurine

Adverse event Brief description of minimum grade NIH common toxicity criteria grade
Haematological
Leucocytes < 2 x 109 / L 3 (or higher)
Haemoglobin < 80g / L 3 (or higher)
Thrombocytes < 50 x 109 / L 3 (or higher)
Gastro-intestinal   
Nausea Oral intake significantly reduced 2 (or higher)
Vomiting Two or more episodes in 24 hours over pre-treatment 2 (or higher)
Anorexia Oral intake significantly reduced 2 (or higher)
Stomatitis (oral ulcers etc.) Painful erythema, oedema or ulcers but can eat/swallow 2 (or higher)
Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher)
Hepatic
Bilirubin > 1.5 x ULN 2 (or higher)
Hepatic enzymes > 2.5 x ULN 2 (or higher)
Dermatological
Rash Rash with associated symptoms over less than 50% of body surface 2 (or higher)
Alopecia Pronounced hair loss 3 (or higher)
Neoplasia
Secondary malignancy (e.g. leukaemia) Present 4
Miscellaneous
Hypersensitivity Rash, drug fever > 380, arthralgia etc. 2 (or higher)
Joint pain Moderate pain/analgesics, significantly interferes with function 2 (or higher)

5-aminosalicylates

Adverse event Brief description of minimum grade NIH common toxicity criteria grade
Blood / Bone Marrow
Anaemia Haemoglobin < 80 g/L 3 (or higher)
Leukopenia Total WCC < 3 x 109 / L 2 (or higher)
Thrombocytopenia Platelets < 50 x 109 / L 3 (or higher)
Neutropenia Total neutrophils < 1.0 x 109 / L 3 (or higher)
Dermatology / Skin
Alopecia Pronounced hair loss 2 (or higher)
Rash / desquamation Scattered macular or papular eruption or erythema with pruritus 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/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 and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a three month period 2 (or higher)
^Serum alkaline phosphatase 2.5 x ULN 2 (or higher)
Neurology / 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)
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)
Seizure(s) Seizures in which consciousness is altered 3 (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/pulmonary infiltrates Radiographic changes, Respiratory Function Test abnormalities and requiring steroids or diuretics 2 (or higher)
Renal
Haematuria Macroscopic (or dipstick +++) confirmed on two separate occasions 2 (or higher)
Proteinuria > 1.0g/24 hours, elevated urine protein/creatinine ratios, (dipstick protein ++ or greater), confirmed on two separate occasions 2 (or higher)
Renal impairment Creatinine > 1.5 ULN or creatinine clearance < 30mL/min 2 (or higher)
Other 
Allergic reaction Urticaria, drug fever > 38°C and / or bronchospasm 2 (or higher)
Fever (in the absence of neutropenia) Body temp > 39°C (oral or tympanic) 2 (or higher)

Page last updated: 25 January 2016

This information was printed Friday 9 December 2016 from humanservices.gov.au/health-professionals/enablers/ulcerative-colitis-toxicity-criteria-and-severity-descriptors It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.