Table 3 Clinical outcomes
Outcome | Rivaroxaban | Standard therapy |
|---|---|---|
Efficacy | ||
Intention-to-treat population, n | 220 | 219 |
Recurrent VTE, n (%) | 7 (3.2) | 7 (3.2) |
Type of first recurrent VTE, n | ||
Fatal PE | 0 | 0 |
Death in which PE could not be ruled out | 1 | 0 |
Non-fatal PE | 2 | 2 |
Recurrent DVT | 4 | 5 |
Net clinical benefit: VTE plus major bleeding, n (%) | 7 (3.2) | 12 (5.5) |
Safety | ||
No. of patients, safety population | 219 | 218 |
First episode of major or clinically relevant non-major bleeding during treatment, n (%) | 13 (5.9) | 20 (9.2) |
Major bleeding episode, n (%) | 0 | 5 (2.3) |
Fatal | 0 | 2 |
Gastrointestinal | 0 | 1 |
Intracranial | 0 | 1 |
Other non-fatal episode in a critical site | 0 | 1 |
Intracranial | 0 | 1 |
Associated with a fall in hemoglobin of ≥2 g/dL, transfusion of ≥2 units, or both | 0 | 2 |