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Activity Number:
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109
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Type:
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Contributed
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Date/Time:
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Monday, August 4, 2008 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301473 |
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Title:
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Identifying Endpoints and Analysis Methodologies in the Assessment of Treatment Effects on Nocturia Episodes in Patients with Overactive Bladders
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Author(s):
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Xiaojiang Zhan+ and Liang Chen*+ and Weili He
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck Research Laboratories
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Address:
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126 E Lincoln Ave, , Rahway, NJ, 07065, 126 E Lincoln Ave, Rahway, NJ, 07065,
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Keywords:
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overactive bladder ; nocturia ; recurrent events ; GEE model ; Longitudinal linear model
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Abstract:
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In the treatment of postmenopausal women with Overactive Bladder (OAB), a benefit to nocturia could be important for a novel OAB drug. However, clinical endpoints and statistical methodologies have not been systematically identified and investigated for the assessment of treatment effects on nocturia episodes. Several nocturia endpoints, such as averaged daily number of nocturia episodes/8hours and number of nocturia episodes per diary week, and a few statistical models, including the longitudinal linear model and GEE model, were proposed and investigated. Simulation studies were conducted to evaluate the properties of these endpoints and the statistical models. In the presentation, we will discuss the endpoint selection for nocturia symptoms and propose analysis approaches for these endpoints.
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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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