Abstract #300880


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JSM 2002 Abstract #300880
Activity Number: 213
Type: Contributed
Date/Time: Tuesday, August 13, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section*
Abstract - #300880
Title: Statistical Analysis of Complicated Adverse Event Data in Clinical Trials
Author(s): Tailiang Xie*+ and Ping Zhao and Joel Waksman
Affiliation(s): WhiteHall-Robins, American Home Product and Whitehall-Robins, American Home Product and Whitehall-Robins, American Home Product
Address: 1 DC, Five Giralda Farms, Madison, New Jersey, 07940, U.S.A.
Keywords: adverse event ; crude rate ; multivariate survival analysis ; Poisson process ; graphical presentation
Abstract:

The crude rate of adverse events (AEs), the proportion of subjects with at least one occurrence of AE, is commonly used for summarizing and analyzing safety data in clinical trials. This approach may be efficient and sufficient for acute drug use in single-dose trials. But in multiple-dose clinical trials, subjects could potentially experience multiple occurrences of the same AE due to multiple exposures of study medication. Clearly, the "crude rate" could be misleading without taking into account multiple exposures of medication and multiple occurrences of AE, and more sophisticated statistical methods may be warranted. The purpose of this paper is to compare some methods of summarizing and analyzing complicated AE data, especially for AEs with differential duration and multiple occurrences. Poisson process and multivariate survival analytical methods will be compared with the usual "crude rate" method, using simulated and real data as examples. Useful graphical presentations will be illustrated.


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