| Project Title | Dabigatran, Warfarin and GI Bleed, Intracerebral Hemorrhage |
| Date Posted | Friday, May 3, 2013 |
| Project ID | MSY3_MPR31-p2 |
| Status | Complete |
| Deliverables | |
| Description | Modular program-based one-time assessment of gastrointestinal (GIH) and/or intracerebral hemorrhage (ICH) events following new use of dabigatran or 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. This report is similar to other modular program reports based on FDA queries concerning dabigatran, warfarin, and gastrointestinal and intracranial hemorrhages. Please refer to each report's specifications sheet for exact parameters. 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) serious bleeding |
| Population / Cohort | All individuals with pre-existing atrial fibrillation |
| Time Period | 2010 - 2011 |
| Assessment Type | Exploratory Analyses |
| Study Type | Modular Program |
| Data Sources | Mini-Sentinel Distributed Database (MSDD) |
| FDA Center | CDER |
