Anticoagulants and Bleeding Events

Project Title Anticoagulants and Bleeding Events
Date Posted
Friday, May 20, 2016
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of exposure to two anticoagulant medications and bleeding events with and without a pre-existing condition of atrial fibrillation (ICD-9-CM 427.31). The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 19, 2010 to December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information.  Queries were distributed in July 2013. This report includes data from 18 Data Partners.

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Medical Product
anticoagulant
dabigatran
warfarin
Health Outcome
bleeding event
Population / Cohort
All individuals
Time Period
October 19, 2010 - December 31, 2012
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER