Event | Edoxaban 30 mg QD (n = 303) | Enoxaparin 2000 IU BID (n = 301) | Absolute difference % (95 % CI) | P | ||
---|---|---|---|---|---|---|
n (%) | 95 % CI | n (%) | 95 % CI | |||
Major bleeding | 2 (0.7) | 0.2, 2.4 | 6 (2.0) | 0.9, 4.3 | −1.3 (−3.7, 0.7) | 0.176 |
Subcutaneous hemorrhage | 1 (0.3) | NC | 2 (0.7) | NC | NC | NC |
Wound hemorrhage | 1 (0.3) | - | 1 (0.3) | - | - | - |
Duodenal ulcer hemorrhage | 0 (0.0) | - | 2 (0.7) | - | - | - |
Hemarthrosis | 0 (0.0) | - | 1 (0.3) | - | - | - |
CRNM bleeding | 6 (2.0) | 0.9, 4.3 | 5 (1.7) | 0.7, 3.8 | 0.3 (−2.1, 2.8) | 0.769 |
Subcutaneous hemorrhage | 1 (0.3) | NC | 0 (0.0) | NC | NC | NC |
Wound hemorrhage | 1 (0.3) | - | 0 (0.0) | - | - | - |
Conjunctival hemorrhage | 1 (0.3) | - | 0 (0.0) | - | - | - |
Epistaxis | 1 (0.3) | - | 0 (0.0) | - | - | - |
Lower gastrointestinal hemorrhage | 1 (0.3) | - | 0 (0.0) | - | - | - |
Hematuria | 1 (0.3) | - | 1 (0.3) | - | - | - |
Postprocedural hematoma | 0 (0.0) | - | 3 (1.0) | - | - | - |
Subcutaneous hematoma | 0 (0.0) | - | 1 (0.3) | - | - | - |
Major or CRNM bleeding | 8 (2.6) | 1.3, 5.1 | 11 (3.7) | 2.1, 6.4 | −1.0 (−4.1, 1.9) | 0.475 |
Minor bleeding | 57 (18.8) | 14.8, 23.6 | 39 (13.0) | 9.6, 17.2 | 5.9 (0.0, 11.7) | 0.049 |
Any bleeding | 62 (20.5) | 16.3, 25.4 | 48 (15.9) | 12.2, 20.5 | 4.5 (−1.7, 10.7) | 0.151 |