Table 2.
Key Efficacy Results in the MAGELLAN and in the MAGELLAN Subpopulation.
| Endpoint/Components | MAGELLAN | MAGELLAN Subpopulation | ||||
|---|---|---|---|---|---|---|
| Modified ITT, day 35 | Rivaroxaban N = 2967, n (%) | Enoxaparin N = 3057, n (%) | RR (95% CI) | Rivaroxaban N = 2419, n (%) | Enoxaparin N = 2506, n (%) | RR (95% CI) |
| Any event | 131 (4.4) | 175 (5.7) | 0.77 (0.62-0.96) | 94 (3.9) | 143 (5.7) | 0.68 (0.53-0.88) |
| Symptomatic lower extremity DVT | 13 (0.4) | 15 (0.5) | 9 (0.4) | 10 (0.4) | ||
| Symptomatic nonfatal PE | 10 (0.3) | 14 (0.5) | 7 (0.3) | 10 (0.4) | ||
| Asymptomatic proximal DVT | 103 (3.5) | 133 (4.4) | 73 (3.0) | 110 (4.4) | ||
| VTE-related death | 19 (0.6) | 30 (1.0) | 15 (0.6) | 26 (1.0) | ||
| Per protocol, day 10 | Rivaroxaban, N = 2938, n (%) | Enoxaparin, N = 2993, n (%) | RR (95% CI) | Rivaroxaban N = 2385, n (%) | Enoxaparin N = 2433, n (%) | RR (95% CI) |
| Any event | 78 (2.7) | 82 (2.7) | 0.97 (0.71-1.31) | 58 (2.4) | 72 (3.0) | 0.82 (0.58-1.15) |
| Symptomatic lower extremity DVT | 7 (0.2) | 6 (0.2) | 6 (0.3) | 4 (0.2) | ||
| Symptomatic nonfatal PE | 6 (0.2) | 2 (<0.1) | 5 (0.2) | 2 (<0.1) | ||
| Asymptomatic proximal DVT | 71 (2.4) | 71 (2.4) | 52 (2.2) | 62 (2.5) | ||
| VTE-related death | 3 (0.1) | 6 (0.2) | 2 (<0.1) | 6 (0.2) | ||
Abbreviations: CI, confidence interval; DVT, deep vein thrombosis; mITT, modified intent to treat; PE, pulmonary embolism; RR, relative risk; VTE, venous thromboembolism.