| Project Title | Ischemic Stroke, Intracranial Hemorrhage, and Gastrointestinal Hemorrhage Among New Users of Apixaban and Warfarin |
| Date Posted |
Wednesday, July 10, 2019 |
| Project ID |
cder_mpl1r_wp056 |
| Status |
Complete |
| Deliverables | |
| Description |
This analysis obtained counts of new users of apixaban and warfarin among patients in the Sentinel Distributed Database (SDD). This analysis also examined incidence rates of ischemic stroke, intracranial hemorrhage, and gastrointestinal hemorrhage among new users of apixaban compared to new users of warfarin with non-valvular atrial fibrillation in the SDD. Data from February 1, 2013 to August 31, 2017 from 17 Data Partners contributing to the SDD were included in this report. This request was distributed to Data Partners on February 1, 2018. |
| Medical Product |
apixaban warfarin |
| Health Outcome |
gastrointestinal hemorrhage intracranial hemorrhage ischemic stroke |
| Population / Cohort |
Individuals 21 years of age or older |
| Time Period |
February 1, 2013 - August 31, 2017 |
| Assessment Type |
Exploratory Analyses |
| Study Type |
Modular Program |
| Data Sources |
Sentinel Distributed Database (SDD) |
| FDA Center |
CDER |
Ischemic Stroke, Intracranial Hemorrhage, and Gastrointestinal Hemorrhage Among New Users of Apixaban and Warfarin
