Clinical outcomes in the modified intention to treat population in patients randomized to rivaroxaban or placebo
| Outcome . | Rivaroxaban (n = 287) . | Placebo (n = 282) . | Risk difference* (95% CI) . | P value . | Hazard ratio (95% CI) . | P value† . |
|---|---|---|---|---|---|---|
| Primary efficacy outcome | ||||||
| Symptomatic objectively-confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death at 28 ± 2 d from laparoscopic surgery for colorectal cancer, n (%) | 3 (1.0) | 11 (3.9) | −0.029 (−0.054 to −0.003) | .028 | 0.27 (0.07-0.96) | .032 |
| Symptomatic VTE, n (%) | 1 (0.3) | 4 (1.4) | — | — | — | — |
| Asymptomatic ultrasonography-detected VTE | 2 (0.7) | 7 (2.5) | — | — | — | — |
| Proximal DVT, n (%)‡ | 0 | 4 (1.4) | — | — | — | — |
| PE or VTE-related deaths, n (%) | 0 | 0 | — | — | — | — |
| Primary safety outcome | ||||||
| Major bleeding, n (%)§ | 2 (0.7) | 0 | — | — | — | — |
| Secondary outcomes | ||||||
| Symptomatic objectively-confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 28 ± 2 d from surgery, n (%) | 5 (1.7) | 11 (3.9) | −0.022 (−0.049 to 0.006) | .120 | 0.44 (0.15-1.27) | .129 |
| Symptomatic objectively-confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 90 ± 2 d from surgery, n (%) | 6 (2.1) | 12 (4.2) | −0.022 (−0.050 to 0.007) | .141 | 0.49 (0.18-1.31) | .143 |
| Clinically relevant exploratory outcomes | ||||||
| Nonmajor bleedings,‖ n (%) | 3 (1.0) | 5 (1.8) | — | — | — | — |
| Death from any cause at 90 d,¶ n (%) | 0 | 1 (0.3) | — | — | — | — |
| Outcome . | Rivaroxaban (n = 287) . | Placebo (n = 282) . | Risk difference* (95% CI) . | P value . | Hazard ratio (95% CI) . | P value† . |
|---|---|---|---|---|---|---|
| Primary efficacy outcome | ||||||
| Symptomatic objectively-confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death at 28 ± 2 d from laparoscopic surgery for colorectal cancer, n (%) | 3 (1.0) | 11 (3.9) | −0.029 (−0.054 to −0.003) | .028 | 0.27 (0.07-0.96) | .032 |
| Symptomatic VTE, n (%) | 1 (0.3) | 4 (1.4) | — | — | — | — |
| Asymptomatic ultrasonography-detected VTE | 2 (0.7) | 7 (2.5) | — | — | — | — |
| Proximal DVT, n (%)‡ | 0 | 4 (1.4) | — | — | — | — |
| PE or VTE-related deaths, n (%) | 0 | 0 | — | — | — | — |
| Primary safety outcome | ||||||
| Major bleeding, n (%)§ | 2 (0.7) | 0 | — | — | — | — |
| Secondary outcomes | ||||||
| Symptomatic objectively-confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 28 ± 2 d from surgery, n (%) | 5 (1.7) | 11 (3.9) | −0.022 (−0.049 to 0.006) | .120 | 0.44 (0.15-1.27) | .129 |
| Symptomatic objectively-confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 90 ± 2 d from surgery, n (%) | 6 (2.1) | 12 (4.2) | −0.022 (−0.050 to 0.007) | .141 | 0.49 (0.18-1.31) | .143 |
| Clinically relevant exploratory outcomes | ||||||
| Nonmajor bleedings,‖ n (%) | 3 (1.0) | 5 (1.8) | — | — | — | — |
| Death from any cause at 90 d,¶ n (%) | 0 | 1 (0.3) | — | — | — | — |
According to the Mantel-Haenszel method.
Log-rank P value.
Proximal DVT was symptomatic in 2 placebo patients.
Both major bleedings were dehiscence of surgical anastomosis occurring during study treatment: the first occurring at 11 d from randomization (17 d from transanal total mesorectal excision); the second occurring at 12 d from randomization (19 from right hemicolectomy).
Four were clinically relevant nonmajor bleeding, 2 in patients randomized to placebo and 2 in patients randomized to rivaroxaban.
One additional placebo patient died 108 d after surgery due to cancer progression.