PRO-CTCAE, the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, is a measurement system developed by the US National Cancer Institute (NCI) so people in cancer clinical trials can report symptomatic adverse events themselves. Its item library has 124 items covering 78 symptoms drawn from CTCAE, asking about frequency, severity, interference with daily activities, presence or absence, and amount, over the past 7 days. Each response is scored 0 to 4, or 0/1 for absent or present. PRO-CTCAE responses are the patient's own report, not CTCAE grades, and NCI's guidance is to use and report them alongside the CTCAE grades clinicians assign. NCI publishes translations in more than 60 languages. In trials on Burna AI, participants answer PRO-CTCAE items in Healthnotes, the participant app a sponsor deploys through its sites, and clinicians grade separately.
More on pro-ctcae and patient reporting.
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