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Abstract Details
Activity Number:
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89
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Type:
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Contributed
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #302536 |
Title:
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Analysis of a Composite Endpoint Under Different Censoring Schemes for Component Events
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Author(s):
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Chunlei Ke*+ and Beiying Ding and Jianming Wang and Qi Jiang
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Companies:
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Amgen Inc. and Amgen Inc. and Novartis Oncology and Amgen Inc.
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Address:
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One Amgen Drive, Thousand Oaks, CA, 91320,
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Keywords:
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Composite endpoint ;
censoring ;
Kaplan Merier estiatme
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Abstract:
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Composite Endpoints are common in clinical trials, especially in the context of survival analysis. Time to a composite endpoint is defined as time from randomization to the first occurrence of any of the component events. Different component events may have different censoring mechanisms, which may lead to different censoring times. Usually some ad-hoc methods, eg, using the longest censoring time, are chosen for simplicity. These conventional approaches, however, may lead to biased or inconsistent estimate of survival function and treatment effect. We first propose a generalized Kaplan-Meier estimate of the survival function for the composite endpoint under certain conditions. A Greenwood-type asymptotic variance estimate is derived. We then extend the log-rank test to make comparisons of the survival functions. Some simulations and applications to real data are also presented.
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