Table 4.
Bleeding outcomes in the entire patient population
| Outcome Parameter | VKA (n=44) | Rivaroxaban (n=46) | Rivaroxaban and Vitamin K2 (n=42) | P Cox | P Cox-adj |
|---|---|---|---|---|---|
| Total bleeding | 24 (49) | 21 (38) | 22 (34) | 0.03 | 0.19 |
| Life-threatening bleeding | 11 (12) | 3 (3) | 6 (8) | 0.05 | 0.08 |
| Major bleeding | 10 (18) | 6 (8) | 4 (4) | 0.12 | 0.19 |
| Life-threatening or major bleeding | 17 (30) | 8 (11) | 9 (12) | 0.04 | 0.05 |
| Minor bleeding | 13 (19) | 16 (27) | 16 (22) | 0.85 | 0.64 |
| Gastrointestinal bleeding | 12 (23) | 9 (16) | 13 (19) | 0.35 | 0.48 |
Cell entries are number of patients with at least one bleeding episode (total number of bleeding episodes). P Cox, significance of differences in time to first bleeding episode according to Cox proportional hazard model analysis; P Cox-adj, P Cox adjusted for competing risk of death.