Table 3

Safety outcomes in the safety population, n = 542

RivaroxabanLMWM/VKA n = 137
20 mg, n = 13530 mg, n = 13440 mg, n = 136
Principal safety outcome, n (%)8 (5.9)8 (6.0)3 (2.2)12 (8.8)
    5% CI*2.6%-11.3%2.6%-11.4%0.5%-6.3%4.6%-14.8%
    Major bleeding, n (%)1 (0.7)2 (1.5)0 (0.0)2 (1.5)
    Clinically relevant, nonmajor bleeding, n (%)7 (5.2)6 (4.5)3 (2.2)10 (7.3)
Any bleeding, n (%)31 (23.0)29 (21.6)29 (21.3)38 (27.7)
Death (any cause), n (%)4 (3.0)8 (6.0)2 (1.5)5 (3.6)
    PE0 (0)0 (0)0 (0)0 (0)
    Unexplained, PE not excluded0 (0)2 (1.5)1 (0.7)0 (0)
    Bleeding0 (0)0 (0)0 (0)1 (0.7)
    Malignancy3 (2.2)4 (3.0)1 (0.7)3 (2.2)
    Other1 (0.7)2 (1.5)0 (0)1 (0.7)