Table 2

Efficacy outcomes in the per-protocol population, n = 449

RivaroxabanLMWH/VKA n = 101
20 mg, n = 11530 mg, n = 11240 mg, n = 121
Primary efficacy outcome
    n (%)7 (6.1)6 (5.4)8 (6.6)10 (9.9)
    95% CI*2.5%-12.1%2.0%-11.3%2.9%-12.6%4.9-17.5%
Symptomatic events, n (%)3 (2.6)4 (3.6)2 (1.7)7 (6.9)
    Death (VTE-related)0 (0.0)2 (1.8)1 (0.8)0 (0.0)
    PE, nonfatal1 (0.9)1 (0.9)0 (0.0)1 (1.0)
    Recurrent DVT2 (1.7)1 (0.9)1 (0.8)7 (6.9)
Asymptomatic deterioration on ultrasound and/or perfusion lung scanning, n (%)4 (3.5)2 (1.8)6 (5.0)3 (3.0)
  • CI indicates confidence interval; DVT, deep vein thrombosis; PE, pulmonary embolism; and VTE, venous thromboembolism.

  • * Two-sided 95% confidence intervals are presented.

  • One patient presented with both DVT and PE.