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Activity Number:
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25
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Type:
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Contributed
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Date/Time:
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Sunday, August 6, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305756 |
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Title:
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Analysis of a Composite Endpoint with Missing Data in Components
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Author(s):
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Hui Quan*+ and Daowen Zhang and Ji Zhang and Laure Devlamynck
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Companies:
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sanofi-aventis and sanofi-aventis and sanofi-aventis and sanofi-aventis
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Address:
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BX2-416A, 200 Crossing Blvd., Bridgewater, NJ, 08807,
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Keywords:
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data imputation ; estimation bias ; correlated endpoints ; event rate
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Abstract:
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Composite endpoints are often used in clinical trials in order to increase the overall event rates, reduce the sizes of the trials and achieve desired power. Just as any endpoints, missing data can occur in the components of the composite endpoint. If a patient has missing data on some of the components but not all the components, this patient may not have complete data but has partial data for the composite endpoint. The patient should not be discarded from analysis. In this talk, we propose approaches for the analysis of composite endpoint with missing data in components. The main idea is first to derive the rates for individual components based on the appropriate model and then to combine them to obtain the overall rate for the composite endpoint. Simulation will be used to compare the approaches and a data example will be used to illustrate the application of the approaches.
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