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Background
Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) is being developed to assess symptomatic AEs via child/adolescent self‐report or proxy‐report. This qualitative study evaluates the child's/adolescent's...
PurposeChildren with cancer experience significant toxicities while undergoing treatment. Documentation of adverse events (AEs) in clinical trials is mandated by federal agencies. Although many AEs are subjective, the current standard is clinician reporting. Our long‐term goal is to create and validate a self‐report measure of subjective AEs for children aged 7 years and older that will inform AE...
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