Table 5.
Efficacy Outcomes
| Efficacy outcomes | Rivaroxaban | ASA | ||
|---|---|---|---|---|
|
Part A (N=12) |
Part B (N=64) |
Total (N=76) |
Part B (N=34) |
|
|
Primary efficacy outcome: Any thrombotic event |
1 (8) | 1 (2) | 2 (3) | 3 (9) |
| Ischemic stroke | 0 | 0 | 0 | 1 (3) |
| Pulmonary embolism | 0 | 1 (2) | 1 (1) | 0 |
| Venous thrombosis | 1 (8) | 0 | 1 (1) | 2 (6) |
| Arterial/intracardiac thrombosis | 0 | 0 | 0 | 0 |
Data are given as number (percentage). Percentages were calculated with the number of participants in each group as denominator. Full analysis set: all participants in part A who received at least 1 dose of study drug and all participants in part B who were randomized and received at least 1 dose of study drug. ASA indicates acetylsalicylic acid.