TabsDetailsBasic DetailsDate Posted: Friday, May 3, 2013Status: CompleteMedical Product: warfarinHealth Outcome(s): gastrointestinal hemorrhageintracerebral hemorrhage (ICH)serious bleedingDescription: Modular program-based one-time assessment of gastrointestinal (GIH) and/or intracerebral hemorrhage (ICH) events following new use of warfarin among patients with a pre-existing condition of atrial fibrillation in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information. Programs were executed in June 2012.If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer. Read More Deliverables (3)Mini-Sentinel Modular Program Report: Warfarin & GI bleed, intracerebral hemorrhage:Part1Mini-Sentinel Modular Program Report: Warfarin & GI bleed, intracerebral hemorrhage:Part2Mini-Sentinel Modular Program Report: Warfarin & GI bleed, intracerebral hemorrhage:Part3Additional InformationAdditional DetailsFDA Center: CDERTime Period: 2008 - 2009Study Type: Modular ProgramAssessment Type: Exploratory AnalysesPopulation / Cohort: All individuals with pre-existing atrial fibrillationData Sources: Mini-Sentinel Distributed Database (MSDD)
