A Protocol for Assessment of Dabigatran and Selected Safety Outcomes

Project Title A Protocol for Assessment of Dabigatran and Selected Safety Outcomes
Date Posted
Friday, January 26, 2018
Status
Complete
Deliverables
Related Links
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. Revised versions were approved for implementation by FDA on March 18, 2014, and March 27, 2015. A log of changes is included in the revised protocol (v3.0).

Medical Product
dabigatran
warfarin
Health Outcome
intracranial hemorrhage
ischemic stroke
major extracranial hemorrhage
Population / Cohort
Adults w/diagnosed nonvalvular atrial fibrillation
Assessment Type
Safety Analyses
Study Type
Protocol/Surveillance Plan
Workgroup Leader(s)

Alan 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; David Graham MD, MPH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD 

Workgroup Members

Daniel 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 Pilgrim Health Care Institute and Harvard Medical School, 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; Yu-te Wu PhD; Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, Food and Drug Administration, Silver Springs, MD

Monika Houstoun PharmD; Katrina Mott MS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD

Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER