| Project Title | PROMPT: Rivaroxaban Surveillance |
| Date Posted | Wednesday, January 31, 2018 |
| Status | Complete |
| Deliverables | |
| Related Links | |
| 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 utilized 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 October 29, 2015. A log of changes is included in the revised protocol (v3.0). |
| Medical Product | rivaroxaban warfarin |
| Health Outcome | gastrointestinal (GI) bleed intracranial hemorrhage ischemic stroke |
| Population / Cohort | All adults with atrial fibrillation |
| Assessment Type | Safety Analyses |
| Study Type | Protocol/Surveillance Plan |
| Workgroup Leader(s) | Elizabeth 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, FDA, Silver Spring, MD Marsha Reichman PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD |
| Workgroup Members | Ryan Carnahan PharmD, MS, BCPP; Department of Epidemiology, University of Iowa College of Public Health, Iowa City, IA Joshua Gagne PharmD, ScD; Shirley Wang PhD; 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 Rongmei Zhang PhD; Mark Levenson PhD; Aloka Chakravarty PhD; Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, FDA, Silver Springs, MD David Graham MD, MPH; Ram Tiwari PhD; Mary Ross Southworth PharmD; Margie Goulding PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD Patrick Archdeacon MD, MS; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD Rima Izem PhD, Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Silver Spring, MD Jeffrey Brown PhD; Candace Fuller PhD; Catherine Rogers MPH; Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA |
| Data Sources | Mini-Sentinel Distributed Database (MSDD) |
| FDA Center | CDER |
