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Activity Number:
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495
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 2, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309562 |
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Title:
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Analysis of Recurrent Events Data in Medical Device Clinical Trials
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Author(s):
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Sarah J.H. Kogut*+
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Companies:
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Beckman Coulter, Inc.
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Address:
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1000 Hazeltine Drive, Chaska, MN, 55318,
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Keywords:
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clinical trial ; medical device ; recurrent events ; mean cumulative function (MCF) ; longitudinal data
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Abstract:
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The safety hypothesis for a medical device clinical trial may explore that subjects treated with the test device have fewer major adverse events during the study period as compared with subjects treated with the control. Adverse events of interest may have repeated occurrences. Time-related accumulation of major adverse events within each treatment group can be estimated using the Nelson nonparametric method. This method is based on graphical comparisons and describes the mean number of major adverse events experienced by subjects over time. The mean cumulative function (MCF) difference between test and control groups can be compared using point wise confidence limits at time of events. Examples of MCF plots and conclusions to be observed will be discussed in the context of a cardiovascular medical device clinical trial.
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