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