New Use of Dabigatran or Warfarin and Gastrointestinal Hemorrhage or Intracerebral Hemorrhage Events

Project Title New Use of Dabigatran or Warfarin and Gastrointestinal Hemorrhage or Intracerebral Hemorrhage Events
Date Posted
Tuesday, June 21, 2016
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of gastrointestinal hemorrhage (GIH) or intracerebral hemorrhage (ICH) events following new use of dabigatran or warfarin among all patients with and without a pre-existing condition of atrial fibrillation. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 19, 2010 to June 30, 2013.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 1.0; click here for more information.  Queries were distributed in June 2014. This report includes data from 15 Data Partners.
 
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.

Medical Product
dabigatran
warfarin
Health Outcome
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
Population / Cohort
All individuals
Time Period
October 19, 2010 - June 30, 2013
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER