Table 2.
Time to First Occurrence of Composite Outcome and Components (ITT)
| Endpoint | Rivaroxaban 10 mg | Placebo | Rivaroxaban 10 mg vs. Placebo |
|
|---|---|---|---|---|
| HR (95% CI)∗ | p Value† | |||
| Composite of symptomatic VTE (DVT and nonfatal PE), MI, nonhemorrhagic stroke, CV death | 63/4,909 (1.28) | 87/4,913 (1.77) | 0.72 (0.52–1.00) | 0.049 |
| Symptomatic lower extremity DVT | 2/4,909 (0.04) | 10/4,913 (0.20) | 0.20 (0.04–0.91) | — |
| Symptomatic nonfatal PE | 4/4,909 (0.08) | 11/4,913 (0.22) | 0.36 (0.12–1.14) | — |
| MI | 13/4,909 (0.26) | 8/4,913 (0.16) | 1.62 (0.67–3.92) | — |
| Nonhemorrhagic stroke | 13/4,909 (0.26) | 24/4,913 (0.49) | 0.54 (0.28–1.06) | — |
| CV death | 39/4,909 (0.79) | 42/4,913 (0.85) | 0.93 (0.60–1.44) | — |
Values are n/N (%) unless otherwise indicated. CV death includes VTE-related death. All events were adjudicated by the clinical event committee. Intention-to-treat (ITT): all randomized patients who had valid signed informed consent.
CI = confidence interval; CV = cardiovascular; DVT = deep vein thrombosis; HR = hazard ratio; MI = myocardial infarction; PE = pulmonary embolism; VTE = venous thromboembolism.
∗
HRs (95% CIs) are from Cox proportional hazards model with treatment as the only covariate.
†
The p value (2-sided) for superiority of rivaroxaban versus placebo from Cox proportional hazards model.