TABLE 1.
Categories of total arterial and venous thrombotic events
| Event |
Placebo N = 3278 |
Rivaroxaban N = 3286 |
Total N = 6564 |
|---|---|---|---|
| Total thrombotic events | 772 | 600 | 1372 |
| Arterial events | 725 (93.9) | 574 (95.7) | 1299 (94.7) |
| Acute limb ischemia | 306 (42.2) | 202 (35.2) | 508 (39.1) |
| Major amputation for vascular causes | 133 (18.3) | 117 (20.4) | 250 (19.2) |
| Non‐fatal myocardial infarction | 170 (23.4) | 152 (26.5) | 322 (24.8) |
| Non‐fatal ischemic stroke | 86 (11.9) | 75 (13.1) | 161 (12.4) |
| Fatal myocardial infarction or stroke | 30 (4.1) | 28 (4.9) | 58 (4.5) |
| Venous events | 47 (6.1) | 26 (4.4) | 73 (5.3) |
| Non‐fatal venous thromboembolic event* | 41 (87.2) | 25 (96.1) | 66 (90.4) |
| Fatal pulmonary embolism or other fatal thromboembolic event | 6 (12.8) | 1 (3.8) | 7 (9.6) |
*Investigator‐reported; not subject to adjudication by independent committee.
Numbers in parentheses are % of total thrombotic events.
Fatal thrombotic events, n = 65: 1st event, n = 4; 2nd event, n = 46; 3rd or subsequent event, n = 15.