Feasibility Assessment of Using the Complete Patient‐Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) Item Library

AbstractThe patient‐reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) complements capture of symptomatic adverse events (AEs) by clinicians. Previous trials have typically used a limited subset of relevant symptomatic AEs to reduce patient burden. We aimed to determine the feasibility of administering all 80 AEs included in the PRO‐CTCAE library by approaching consecutive patients enrolled in a large academic phase I program at three points in time. Here, we report a preplanned analysis after enrolling the first 20 patients. All items were answered on 51 of 56 potential visits (adherence 91%). Three (5%) additional PRO‐CTCAE assessments were partially completed, and two (4%) were missed because of conflicting appointments. No patient withdrew consent or chose not to complete the assessments once enrolled on study. Future trials of experimental drugs that incorporate the PRO‐CTCAE should consider using this unselected approach to identify adverse events more completely.

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