Safety outcomes in the safety population, n = 542
| . | Rivaroxaban . | LMWM/VKA n = 137 . | ||
|---|---|---|---|---|
| 20 mg, n = 135 . | 30 mg, n = 134 . | 40 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) |
| PE | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Unexplained, PE not excluded | 0 (0) | 2 (1.5) | 1 (0.7) | 0 (0) |
| Bleeding | 0 (0) | 0 (0) | 0 (0) | 1 (0.7) |
| Malignancy | 3 (2.2) | 4 (3.0) | 1 (0.7) | 3 (2.2) |
| Other | 1 (0.7) | 2 (1.5) | 0 (0) | 1 (0.7) |
| . | Rivaroxaban . | LMWM/VKA n = 137 . | ||
|---|---|---|---|---|
| 20 mg, n = 135 . | 30 mg, n = 134 . | 40 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) |
| PE | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Unexplained, PE not excluded | 0 (0) | 2 (1.5) | 1 (0.7) | 0 (0) |
| Bleeding | 0 (0) | 0 (0) | 0 (0) | 1 (0.7) |
| Malignancy | 3 (2.2) | 4 (3.0) | 1 (0.7) | 3 (2.2) |
| Other | 1 (0.7) | 2 (1.5) | 0 (0) | 1 (0.7) |