|Project Title||Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System|
Wednesday, January 10, 2018
The U.S. Food and Drug Administration's Sentinel System developed tools for sequential surveillance. This tool was used to sequentially compare outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety.
gastrointestinal (GI) bleed
Mini-Sentinel Distributed Database (MSDD)