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Event Adjudication Changes Key Results In Open-Label Trials: The Affirm Experience, Elaine M. Nasco, April Slee, Kent M. Koprowicz, Robert G. Hart
Event Adjudication Changes Key Results In Open-Label Trials: The Affirm Experience, Elaine M. Nasco, April Slee, Kent M. Koprowicz, Robert G. Hart
Kent M Koprowicz
Event Adjudication Changes Key Results in Open-Label Trials: The AFFIRM Experience Author Block: Elaine M. Nasco, April Slee, Kent Koprowicz, Robert G. Hart, Axio Research, LLC, Seattle, WA Abstract: Background: The value of central event adjudication of endpoints in multi-center randomized trials has recently been questioned. Methods: The NIH-sponsored Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial randomized 4,060 atrial fibrillation patients to antiarrhythmic drugs (rhythm control) vs. rate-controlling drugs, given open-label, at 213 clinical sites. While the primary outcome was mortality, a key secondary endpoint was ischemic stroke (IS), centrally adjudicated by those reviewing source documents from which …