Edoxaban 30 mg QD (n = 303) | Enoxaparin 2000 IU BID (n = 301) | |
---|---|---|
Adverse events | ||
Patients with events | 197 (65.0) | 232 (77.1) |
95 % CI | 59.5, 70.2 | 72.0, 81.5 |
Number of events | 448 | 676 |
Adverse events reported by ≥5 % of patients in either treatment group a | ||
ALT increased | 36 (11.9) | 126 (41.9) |
AST increased | 17 (5.6) | 97 (32.2) |
γ-glutamyltransferase increased | 44 (14.5) | 79 (26.2) |
Blood urine present | 38 (12.5) | 34 (11.3) |
Blood alkaline phosphatase increased | 14 (4.6) | 40 (13.3) |
Hemorrhage subcutaneous | 12 (4.0) | 21 (7.0) |
Adverse drug reactions | ||
Patients with events | 121 (39.9) | 177 (58.8) |
95 % CI | 34.6, 45.5 | 53.2, 64.2 |
Number of events | 198 | 439 |
Hepatic function test parameter | ||
ALT or AST | ||
≥1.5 x ULN | 43 (14.2) | 135 (44.9) |
≥3 x ULN | 8 (2.6) | 30 (10.0) |
≥5 x ULN | 2 (0.7) | 11 (3.7) |