Statistical Analyses of Adverse Event Data from Clinical Trials

1 January 1987

journal article
other
Published by Springer Nature in Drug Information Journal

Vol. 21 (1) , 9-20
https://doi.org/10.1177/009286158702100104

Abstract

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.

Keywords

SERIOUS EVENTS
RATES OF OCCURRENCE
CRUDE RATE
DRUG EXPOSURE

This publication has 2 references indexed in Scilit:

Discovery of New Adverse Drug Reactions
JAMA, 1984
Cimetidine Postmarket Outpatient Surveillance Program
Published by American Medical Association (AMA) ,1980