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Abstract Details

Activity Number: 59
Type: Topic Contributed
Date/Time: Sunday, July 29, 2012 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306320
Title: Some Practical Aspects of Recurrent Event Endpoints in the Assessment of Therapeutic Effects
Author(s): Heng Li*+ and Vandana Mukhi and Yu (Audrey) Zhao and Yun-Ling Xu
Companies: FDA/CDRH and FDA/CDRH and FDA/CDRH and FDA/CDRH
Address: WO66 RM2238, Silver Spring, MD, 20993, United States
Keywords: Andersen-Gill ; Days Alive Out of Hospital ; Poisson
Abstract:

Survival data has had a central place in medical statistics since reducing mortality is the ultimate objective of many medical therapies. However, time to events other than death are also often of interest in addition to survival. Such events may occur more than once during a patient's follow-up in a clinical study. Statistical analysis techniques that deal with such recurrent events are needed. In this presentation we will provide the motivation for using endpoints involving recurrent event types of data and discuss possible statistical strategies for their analyses.


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