Statistical analyses of adverse event data from clinical trials. Special emphasis on serious events.
The purpose of this paper is to describe some methods for analyzing and summarizing adverse event rates from clinical trials, emphasizing, in particular, serious adverse drug events and their time of occurrence, and the impact of differential subject exposure and pretreatment status on the estimation of rates.
D002986:Clinical Trials as Topic; D003625:Data Collection / Q000379:methods; D004341:Drug Evaluation / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D013223:Statistics as Topic