How to improve toxicity evaluation in clinical trials? Testing new metrics from irinotecan or oxaliplatin-based treatments in metastatic colorectal cancer (mCRC): A pooled analysis from 2,349 patients in ARCAD database.

89 Background: Monitoring of adverse events (AE) is crucial in clinical trials. Maximum grade per patient (pt) is commonly used but better metrics are needed to aid describing and comparing AE profiles. Methods: We developed and evaluated 2 longitudinal AE summary metrics. 1) Onset time of max grade refers to whether a pt has max grade within pre-specified timeframes for an AE, e.g. onset can be defined as “early” (max grade before the 6 th cy)...