Table 1 Toxicity categories used in the phase I study reports examined, as per the Common Terminology Criteria for Adverse Events, version 4.0.

From: Pre-clinical animal models are poor predictors of human toxicities in phase 1 oncology clinical trials

Toxicity category

Common human toxicities

Common animal toxicities

Cardiovascular

Hypertension, tachycardia, bradycardia, dyslipidemia

Tachycardia, bradycardia

Cutaneous

Rash, alopecia

Rash, fur discoloration

Endocrine

Diabetes

Increase in endocrine system organs

Gastrointestinal

Nausea, vomiting, diarrhoea

Loose stool

General

Fatigue, fever, chills

Decreased activity

Haematologic

Neutropenia, thrombocytopenia

Changes in red blood cells or white blood cells

Hepatic

Changes in alanine transaminase or aspartate transaminase

Changes in alanine transaminase or aspartate transaminase

Metabolic

Anorexia, decreased appetite, hyperglycaemia

Decreased food consumption

Musculoskeletal

Muscle pain, back pain

Awkward gait, hunched posture

Neurologic/psychiatric

Headache, insomnia

Tremors

Ocular

Blurred vision

Bloody tears

Renal

Changes in creatinine or blood urea nitrogen

Blood in urine

Respiratory

Cough, shortness of breath

Laboured breathing