Open AccessAdverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials
Author(s) -
Guilherme S. Lopes,
Christophe Tournigand,
Curtis Olswold,
Romain Cohen,
Emmanuelle Kempf,
Leonard Saltz,
Richard M. Goldberg,
Herbert I. Hurwitz,
Charles S. Fuchs,
Aimery de Gramont,
Qian Shi
Publication year - 2020
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/1740774520959313
Subject(s) - adverse effect , medicine , event (particle physics) , clinical trial , adverse event reporting system , physics , quantum mechanics
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.