Exploration Of Pro-Ctcae Data Used For Exposure-Response Relationships In An Oncology Clinical Trial

Background: Exposure-response (ER) analysis is used in oncology clinical trials to characterize the relationship between drug exposure and safety outcomes. PRO-CTCAE is a patient-reported outcomes (PRO) version of the common terminology criteria for adverse events (CTCAE). PRO-CTCAE was developed by the National Cancer Institute to assess patient-reported symptomatic adverse events in clinical trials to complement standard clinician reported adverse events. We used data from PRO-CTCAE to explore how the systematic assessment of symptomatic adverse events by PRO-CTCAE could inform ER safety and tolerability analyses.