XARELTO (rivaroxaban) - Increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement

In August 2018, the Data Safety Monitoring Board (DSMB), while monitoring patient safety independently in the phase III clinical study (GALILEO) in patients after transcatheter aortic valve replacement (TAVR), recommended stopping the study based on preliminary results showing an increase in all-cause mortality, thromboembolic and bleeding events in XARELTO-treated patients.

Product safety