Patient Reported Outcomes And The Common Terminology Criteria For Adverse Events (CTCAE)

By Kristen Mason, MS

The Common Terminology Criteria for Adverse Events (CTCAE) was developed to standardize reporting of adverse events (AEs). Originally developed for oncology trials by the National Cancer Institute (NCI), the CTCAE is now used widely across all types of clinical trials, and as a result has become an essential tool for evaluating trial safety. The CTCAE provides a library of over 800 AEs with guidelines for grading event severity. However, it fails to capture the day to day effects a patient might experience. In order to integrate the patient’s perspective into AE reporting, the NCI developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

The PRO-CTCAE consists of 78 AEs with questions regarding the presence/absence, severity, frequency, and/or interference of symptomatic treatment side effects. These AEs were identified as symptoms that can be meaningfully reported by the patient, such as pain, fatigue, and nausea. Continue reading to understand how the perspectives of the clinician and the patient differ, what else can be learned and what are the next steps.