Abstract #300488

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JSM 2003 Abstract #300488
Activity Number: 376
Type: Contributed
Date/Time: Wednesday, August 6, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300488
Title: Assessment of Adverse Events in Titration Studies
Author(s): Balakrishna S. Hosmane*+ and Yonghang (Fred) Yang
Companies: Northern Illinois University and Aventis Pharmaceuticals, Inc.
Address: 555 Fox Hollow, Dekalb, IL, 60115-2390,
Keywords: adverse event ; GEE ; clinical trials ; goodness of fit ; titration studies
Abstract:

The titration design is widely used in hypertension clinical trials and the analysis of adverse events is an important part of the safety assessment of the drug. The generalized estimating equations (GEE) methodology is one of the choices for analyzing longitudinal dependent binary adverse events data. We present how we assess the goodness of fit of the link function and the goodness of fit of the working correlation structure in dependent binary regression model using GEE. The methodology will be illustrated using a data from a hypertension clinical trial to model incidence of adverse events.

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