XARELTO®: Safety profile in initial treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Proven safety profile in initial DVT/PE treatment1,2
Similar rates of the composite of clinically relevant nonmajor and major bleeding in EINSTEIN PE*1
10.3% (249/2412) with XARELTO® versus 11.4% (274/2405) with enoxaparin and warfarin/VKA
HR (95% CI): 0.90 (0.76-1.07)
Lower rates of major bleeding in EINSTEIN PE1
Lower rates of major bleeding in
EINSTEIN PE1

1.1% (26/2412) with XARELTO® versus 2.2% (52/2405) with enoxaparin and warfarin/VKA
Similar rates of the composite of clinically relevant nonmajor and major bleeding in EINSTEIN DVT*2
8.1% (139/1718) with XARELTO® versus 8.1% (138/1711) with enoxaparin and warfarin/VKA
HR (95% CI): 0.97 (0.76-1.22)
Similar rates of major bleeding in EINSTEIN DVT2
Similar rates of major bleeding in
EINSTEIN DVT2

0.8% (14/1718) with XARELTO® versus 1.2% (20/1711) enoxaparin and warfarin/VKA
‡Not adjusted for multiplicity.
Low rates of bleeding in patients with low-risk PE in HoT-PE§3
1.2% (6/519) of patients experienced major bleeding
(95% CI: 0.4%-2.5%)
◇For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.