What is CTCAE grading?

CTCAE stands for Common Terminology Criteria for Adverse Events, the standardised grading framework published by the National Cancer Institute (NCI) for adverse events in oncology trials. Each adverse event is mapped to a CTCAE term (e.g., fatigue, neutropenia, peripheral neuropathy) and assigned a grade from 1 (mild) to 5 (death related to adverse event). Grade 2 is defined by limitation of instrumental activities of daily living (ADL); Grade 3 by limitation of self-care ADL or hospitalisation; Grade 4 by life-threatening consequences. CTCAE grading is mandatory for FDA-regulated oncology trials and feeds every safety endpoint, every SAE narrative, and every pharmacovigilance signal.