Table 4.
Primary study outcome (major bleeding after day 30 during anticoagulation of 4457 patients available for the primary analysis)
| Overall | Rivaroxaban | Standard of care | Unprovoked VTE | |
|---|---|---|---|---|
| Number of patients in low risk group (absolute risk) | 2818 (63%) | 1770 (72%) | 1048 (53%) | 1765 (62%) |
| Number of patients in high risk group (absolute risk) | 1629 (37%) | 6977 (28%) | 9322 (47%) | 1091 (38%) |
| Crude OR for 1‐point score increase (95% CI) | 1·4 (1·2–1·7) | 1·5 (1·1–2·2) | 1·3 (1·1–1·6) | 1·3 (1·0–1·8) |
| Adjusted OR for 1‐point score increase (95% CI) | 1·4 (1·1–1·6) | n.a. | n.a. | 1·3 (1·0–1·7) |
| Crude HR ≥2 points (95% CI) | 2·6 (1·3–5·2) | 1·9 (0·56–6·5) | 2·5 (1·0–5·8%) | 1·9 (0·77–4·8) |
| Adjusted HR ≥2 points (95% CI) | 2·3 (1·1–4·5) | n.a. | n.a. | 1·7 (0·69–4·4) |
| PPV (95% CI) | 1·5% (0·98–2·2%) | 0·72% (0·31–1·7%) | 2·1% (1·3–3·3%) | 1·1% (0·63–1·9%) |
| NPV (95% CI) | 99·5% (99–100%) | 99·7% (99–100%) | 99·1% (98–100%) | 99·5% (99–100%) |
| c‐statistic (95% CI) | 0·68 (0·59–0·77) | 0·69 (0·55–0·84) | 0·64 (0·52–0·75) | 0·64 (0·51–0·70) |
95% CI, 95% confidence interval; HR, hazard ratio; n.a., not applicable; NPV, negative predictive value; OR, odds ratio; PPV, positive predictive value; VTE, venous thromboembolism.