|Project Title||Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding|
Thursday, April 4, 2013
This article describes FDA’s use of a Mini-Sentinel modular program-based one-time assessment of the risk of gastrointestinal hemorrhage (GIH) or intracerebral hemorrhage (ICH) events associated with use of the anticoagulants (blood thinners) dabigatran and warfarin in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs.
intracerebral hemorrhage (ICH)
|Population / Cohort|
with/without pre-existing atrial fibrillation
Mini-Sentinel Distributed Database (MSDD)