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Activity Number:
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243
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, July 31, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #324115
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Title:
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Analysis of Adverse Event Relationships in Clinical Trials Using JMP
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Author(s):
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Anastasia Dmitrienko* and Kelci Miclaus and Richard C. Zink
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Companies:
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and JMP Life Sciences, SAS Institute Inc. and JMP Life Sciences, SAS Institute, Inc.
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Keywords:
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clinical trials ;
adverse events ;
network plots ;
risk-based monitoring
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Abstract:
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Clinical trials are primarily designed to assess effectiveness of a new therapy but sufficient insight into the tolerability of a treatment is rather difficult to determine. For clinical researchers, analyzing the effects of a drug involves understanding the relationships among a large number of adverse events. A network plot can summarize pairwise relationships between adverse events. The nodes representing the adverse events can be sized according to the number of patients experiencing that particular event, and colored according to an important event characteristic. The edges can be colored according to the strength of the relationship as measured by the odds ratio. These odds ratios can help identify events that may go unreported at a particular site based on the pairs of events have a strong positive relationship (with an odds ratio which is much greater than 1). Pairs of events with a strong negative relationship can identify events that infrequently occur together, a possible indication of inconsistency in coding a medical condition. The adverse event monitoring approach based on network plots is illustrated using a case study using software developed in JMP.
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Authors who are presenting talks have a * after their name.
