Adverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials.

ABSTRACT:

Background

Current adverse event reporting practices do not document longitudinal characteristics of adverse effects, and alternative methods are not easily interpretable and have not been employed by clinical trials. Introducing time parameters in the evaluation of safety that are comprehensive yet easily interpretable could allow for a better understanding of treatment quality. In this study, we developed and applied a novel adverse event reporting method based on longitudinal adverse event changes to aid describing, summarizing, and presenting adverse event profile. We termed it the "Adverse Event Load, Onset, and Maximum Grade" method.

Methods

We developed two adverse event summary metrics to complement the traditional maximum grade report. Onset time indicates the time

SUBMITTER: Lopes GS 

PROVIDER: S-EPMC8009044 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature