Efficacy outcomes in the per-protocol population, n = 449
. | Rivaroxaban . | LMWH/VKA n = 101 . | ||
---|---|---|---|---|
20 mg, n = 115 . | 30 mg, n = 112 . | 40 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, nonfatal | 1 (0.9) | 1 (0.9) | 0 (0.0) | 1 (1.0) |
Recurrent DVT | 2 (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) |
. | Rivaroxaban . | LMWH/VKA n = 101 . | ||
---|---|---|---|---|
20 mg, n = 115 . | 30 mg, n = 112 . | 40 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, nonfatal | 1 (0.9) | 1 (0.9) | 0 (0.0) | 1 (1.0) |
Recurrent DVT | 2 (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) |