Table 3.
Occurrence of adverse events during anticoagulation of 4457 patients available for the primary analysis. Fatal pulmonary embolism included unexplained deaths
| Adverse event | Treatment arm | Incidence, n (%) | |
|---|---|---|---|
| Low risk | High risk | ||
| Major bleeding after day 30 | Rivaroxaban | 6 (0·35) | 5 (0·70) |
| Standard of care | 9 (0·84) | 19 (2·1) | |
| Overall | 15 (0·53) | 24 (1·5) | |
| Major bleeding after day 90 | Rivaroxaban | 2 (0·13) | 3 (0·48) |
| Standard of care | 6 (0·63) | 16 (1·9) | |
| Overall | 8 (0·31) | 19 (1·31) | |
| Recurrent VTE after day 30 | Rivaroxaban | 14 (0·80) | 5 (0·71) |
| Standard of care | 13 (1·3) | 23 (2·5) | |
| Overall | 27 (0·96) | 28 (1·7) | |
| All‐cause mortality after day 30 | Rivaroxaban | 3 (0·19) | 6 (0·81) |
| Standard of care | 6 (0·54) | 69 (7·4) | |
| Overall | 9 (0·32) | 75 (4·6) | |