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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 TitlePROMPT: Rivaroxaban Surveillance Plan v2.0
Date Posted 3-28-2014
Project StatusIn progress
Assessment TypePROMPT
Description

Prospective routine observational monitoring assessment of selected safety outcomes (ischemic stroke, intracranial hemorrhage, and gastrointestinal bleeding) in adults with atrial fibrillation who are new users of rivaroxaban, with warfarin as the comparator. This assessment will utilize Mini-Sentinel’s Prospective Routine Observational Monitoring Programming Tools (PROMPT) surveillance system. Click here for more information about PROMPT.


This surveillance plan was posted for public comment from January 13, 2014 to January 27, 2014. The public comment period is now closed. A revised version was approved for implementation by FDA on March 28, 2014. A log of changes is included in the revised protocol (v2.0).
Medical ProductRivaroxaban, warfarin
Health OutcomeIschemic stroke, intracranial hemorrhage, gastrointestinal bleeding
Population / CohortAdult w/atrial fibrillation
Time Period 
Workgroup LeadersElizabeth Chrischilles, PhD, MS, Department of Epidemiology, University of Iowa College of Public Health, Iowa City, IA; Azadeh Shoaibi, MS, MHS, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Marsha Reichman, PhD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
Workgroup MembersRyan Carnahan, PharmD, MS, BCPP, Department of Epidemiology, University of Iowa College of Public Health, Iowa City, IA; Joshua Gagne, PharmD, ScD, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; Jennifer Nelson, PhD, Biostatistics Unit, Group Health Research Institute and Department of Biostatistics, University of Washington, Seattle, WA; Bruce Fireman, MA, Kaiser Permanente Northern California, Oakland, CA; Shirley Wang, PhD, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; Rongmei Zhang, PhD, Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, Food and Drug Administration, Silver Springs, MD; Mark Levenson, PhD, Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, Food and Drug Administration, Silver Springs, MD; David Graham, MD, MPH, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Ram Tiwari, PhD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Mary Ross Southworth, PharmD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Patrick Archdeacon, MD, MS, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Aloka Chakravarty, PhD, Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, Food and Drug Administration, Silver Springs, MD; Margie Goulding, PhD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD; Jeffrey Brown, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA; Candace Fuller, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA; Darren Toh, ScD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA
Data SourcesMini-Sentinel Distributed Database
Deliverables Mini-Sentinel Prospective Routine Observational Monitoring Program Tools (PROMPT): Rivaroxaban Surveillance Plan v2.0

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KeywordsPROMPT, surveillance plan, rivaroxaban, warfarin, atrial fibrillation, ischemic stroke, intracranial hemorrhage, gastrointestinal bleeding, Carnahan, Gagne, Nelson, Fireman, Shoaibi, Reichman, Zhang, Levenson, Graham, Tiwari, Southworth, Archdeacon, Chakravarty, Goulding, Brown, Fuller, Toh, Chrischilles

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Page Updated: 2014