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Activity Number:
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261
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 5, 2008 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Statistical Graphics
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| Abstract - #302241 |
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Title:
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Graphical Analysis of Adverse Event Data
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Author(s):
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Haijun Ma*+ and H. Amy Xia
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Companies:
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Amgen, Inc and Amgen, Inc
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Address:
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Amgen One Ct. Dr., Thousand Oaks, CA, 91320,
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Keywords:
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safety analysis ; adverse events ; graphics ; clinical trial safety ; safety signal detection
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Abstract:
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Adverse event data play a crucial role in the analysis of clinical trial safety data. In this talk we share our experience in monitoring and analyzing clinical trial adverse event data. We examine various metrics commonly used for adverse event data analysis, approaches that are helpful for identification of adverse drug reactions, methods focused on analysis of Events of Interests and ways to incorporate adverse event data with other safety data. We also discuss challenges in implementing routine monitoring while trials are still ongoing. Statistical graphics, as a powerful statistical analysis tool, are applied as appropriate and discussed through out the talk.
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