Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative

Abstract

The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.