What is PRO-CTCAE?

PRO-CTCAE stands for Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, developed by the National Cancer Institute. Where clinician-graded CTCAE captures the clinician's interpretation of an adverse event, PRO-CTCAE captures the patient's direct experience of frequency, severity, and interference with daily activities. PRO-CTCAE is the foundation of patient-reported safety reporting in modern oncology trials.