| Project Title | Warfarin and GI Bleed, Intracerebral Hemorrhage |
| Date Posted | Friday, May 3, 2013 |
| Project ID | MSY3_MPR31-p3 |
| Status | Complete |
| Deliverables | |
| Description | 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. |
| Medical Product | warfarin |
| Health Outcome | gastrointestinal hemorrhage intracerebral hemorrhage (ICH) serious bleeding |
| Population / Cohort | All individuals with pre-existing atrial fibrillation |
| Time Period | 2008 - 2009 |
| Assessment Type | Exploratory Analyses |
| Study Type | Modular Program |
| Data Sources | Mini-Sentinel Distributed Database (MSDD) |
| FDA Center | CDER |
