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Health Outcomes Among Individuals Exposed to Medical Products Details

Results from Assessments of Health Outcomes Among Individuals Exposed to Medical Products Search
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Project TitleA Protocol for Assessment of Dabigatran and Selected Safety Outcomes
Date Posted 3-26-2014
Project StatusIn progress
Assessment TypeProtocol
Description This protocol will guide a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

This protocol was posted for public comment from December 30, 2013 through January 13, 2014. The public comment period is now closed. A revised version was approved for implementation by FDA on March 18, 2014. A log of changes is included in the revised protocol (v2.0).
Medical ProductDabigatran, warfarin
Health OutcomeIschemic stroke, intracranial hemorrhage, major extracranial hemorrhage
Population / CohortAdults w/diagnosed nonvalvular atrial fibrillation
Time Period 
Workgroup LeadersAlan S. Go, MD, Division of Research, Kaiser Permanente Northern California, Oakland, CA;, Joshua Gagne, PharmD, ScD, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Marsha Reichman, PhD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD; David Graham, MD, MPH, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
Workgroup MembersDaniel Singer, MD, Medicine Division, Massachusetts General Hospital, Boston, MA; T. Craig Cheetham, PharmD, MS, Kaiser Permanente Southern California, Downey, CA; Darren Toh, ScD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA; Mary Ross Southworth, PharmD, Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Rongmei Zhang, PhD, Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, Food and Drug Administration, Silver Springs, MD; Monika Houstoun, PharmD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Yu-te Wu, PhD, Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, Food and Drug Administration, Silver Springs, MD; Katrina Mott, MS, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
Data SourcesMini-Sentinel Distributed Database
Deliverables A Protocol for Assessment of Dabigatran v2.0

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Keywordsassessment protocol, dabigatran, warfarin, atrial fibrillation, ischemic stroke, intracranial hemorrhage, major extracranial hemorrhage, Go, Singer, Cheetham, Toh, Reichman, Graham, Southworth, Zhang, Houstoun, Wu, Mott, Gagne

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Page Updated: 2014