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PROMPT: Rivaroxaban Surveillance

Basic Details
Date Posted
Status
Complete
Medical Product
rivaroxaban
warfarin
Health Outcome(s)
gastrointestinal (GI) bleed
intracranial hemorrhage
ischemic stroke
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).

Deliverables (6)
Mini-Sentinel PROMPT: Rivaroxaban Surveillance Plan Mini-Sentinel Modular Program Report: Rivaroxaban Surveillance, Ischemic Stroke, Monitoring Period 1 Mini-Sentinel Modular Program Report: Rivaroxaban Surveillance, Ischemic Stroke, Monitoring Period 2 Mini-Sentinel Modular Program Report: Rivaroxaban Surveillance, Gastrointestinal Bleed Mini-Sentinel Modular Program Report: Rivaroxaban Surveillance, Intracranial Hemorrhage Appendices: Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Additional Details
FDA Center
CDER
Analysis Type
Summary Table
Population / Cohort
All adults with atrial fibrillation
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Related Links
2017 ICPE Presentation: Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Publication: Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Intracranial Hemorrhage Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Intracranial Hemorrhage"
Gastrointestinal Bleed Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Gastrointestinal Bleed"
Mini-Sentinel Drug Assessment: Xarelto (rivaroxaban) & Intracranial Hemorrhage, Gastrointestinal (GI) Bleed, and Ischemic Stroke
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