Abstract Details
Activity Number:
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173
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Type:
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Contributed
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Date/Time:
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Monday, August 4, 2014 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313164
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View Presentation
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Title:
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Sample Size Under the Additive Hazards Model
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Author(s):
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Lee McDaniel*+ and Menggang Yu and Richard J. Chappell
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Companies:
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University of Wisconsin-Madison and University of Wisconsin-Madison and University of Wisconsin-Madison
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Keywords:
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Sample Size ;
Non-Inferiority ;
Additive Hazards
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Abstract:
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The additive hazards model can be easier to interpret than the proportional hazards model. However, sample size formulas for clinical trials with time to event outcomes are currently based on either the proportional hazards assumption or an assumption of constant hazards. We present sample size formulas for superiority and non-inferiority trials assuming an additive hazards model but no specific distribution. In the non-inferiority case, it is shown that sample size can be slightly reduced if more subjects are randomized to the experimental group than the control group. The non-inferiority sample size formula is then applied to the calculations in the SPORTIF III trial of stroke prevention in atrial fibrillation and the CPORT-E trial of percutaneous coronary intervention. A tool to calculate sample size in a non-inferiority trial under the additive hazards assumption is available on the web at http://www.stat.wisc.edu/ ~mcdaniel/samplesize.html.
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