Rivaroxaban | Enoxaparin/VKA | |
---|---|---|
n = 4130 | n = 4116 | |
First major bleeding, n (%) | ||
Any | 40 (1.0) | 72 (1.7) |
Fatal bleeding | 3 (<0.1) | 8 (0.2) |
Retroperitoneal | 0 | 1 (<0.1) |
Intracranial | 2 (<0.1) | 4 (0.1) |
Gastrointestinal | 1 (<0.1) | 2 (<0.1) |
Thorax | 0 | 1 (<0.1) |
Nonfatal bleeding in a critical site | 10 (0.2) | 27 (0.7) |
Retroperitoneal | 1 (<0.1) | 7 (0.2) |
Intracranial | 3 (<0.1) | 9 (0.2) |
Intraocular | 3 (<0.1) | 3 (<0.1) |
Pericardial | 0 | 2 (<0.1) |
Intra-articular | 0 | 4 (0.1) |
Adrenal | 1 (<0.1) | 0 |
Pulmonary | 1 (<0.1) | 0 |
Abdominal | 1 (<0.1) | 2 (<0.1) |
Nonfatal, noncritical site bleeding but associated with a fall in hemoglobin ≥ 2 g/dl and/or transfusions ≥2 units | 27 (0.7) | 37 (0.9) |
Surgical site | 0 | 3 (<0.1) |
Skin | 1 (<0.1) | 5 (0.1) |
Urogenital | 9 (0.2) | 3 (<0.1)* |
Gastrointestinal | 14 (0.3) | 24 (0.6) |
Nasal | 1 (<0.1) | 0 |
Pulmonary | 1 (<0.1) | 0 |
Intramuscular | 1 (<0.1) | 2 (<0.1) |