Table 1.
Events (Rate)
|
HR (95% CI) | p Value | ||
---|---|---|---|---|
Rivaroxaban (n = 7,111) | Warfarin (n = 7,125) | |||
Principal safety endpoint | 1,475 (14.91) | 1,449 (14.52) | 1.03 (0.96–1.11) | 0.442 |
| ||||
Major | 395 (3.60) | 386 (3.45) | 1.04 (0.90–1.20) | 0.576 |
Hemoglobin/hematocrit drop | 305 (2.77) | 254 (2.26) | 1.22 (1.03–1.44) | 0.019 |
Transfusion | 183 (1.65) | 149 (1.32) | 1.25 (1.01–1.55) | 0.044 |
Critical organ bleeding | 91 (0.82) | 133 (1.18) | 0.69 (0.53–0.91) | 0.007 |
Death | 27 (0.24) | 55 (0.48) | 0.50 (0.31–0.79) | 0.003 |
| ||||
Nonmajor clinically relevant | 1,185 (11.80) | 1,151 (11.37) | 1.04 (0.96–1.13) | 0.345 |
| ||||
Minimal | 258 (2.35) | 226 (2.03) | 1.16 (0.97–1.39) | 0.102 |
Event rates/100 patient-years.
CI = confidence interval; HR = hazard ratio.