Illustrative Integration of Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Data in Dose-Cohort Review for a Phase I Clinical Trial
This paper illustrates how integrating Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) with clinician-graded CTCAE data in a Phase I acute myeloid leukemia trial provides a more comprehensive assessment of patient symptom burden and tolerability to inform dose-escalation decisions.