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Activity Number: 110 - Assessing Treatment Effects for Life History Processes
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329118 Presentation
Title: Comparison of Event Rates Between On- and Off-Drug Treatment Periods for a Recurrent Adverse Event
Author(s): Brenda Crowe* and Haoda Fu and Yebin Tao
Companies: Eli Lilly & Co. and Eli Lilly and Company and Eli Lilly and Company
Keywords: survival analysis; time to event analysis; recurrent events

This talk is motivated by a problem related to a drug with a short half-life that is given "as needed" (for example for the treatment of migraine headaches). There is interest in using on- and off-drug treatment periods from a long open-label extension (in which all patients had the drug available to them) to test if certain pre-specified adverse events were associated with the use of the drug. We propose a Poisson regression model with random effects, which assumes constant hazards, constant hazard ratio and non-informative censoring. Simulation results are provided to show the performance of our method under different settings related to sample size and effect size. This work provides insights on how to model more complex cases where the preceding assumptions might not hold.

Authors who are presenting talks have a * after their name.

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