Table 2 Crude incidences of recurrent venous thromboembolism and major bleeding in Asian patients receiving rivaroxaban, placebo, or aspirin according to baseline risk factor profiles
Risk factor profile | EINSTEIN Extension | EINSTEIN CHOICE | EINSTEIN CHOICE | EINSTEIN Extension and EINSTEIN CHOICE | EINSTEIN Extension | EINSTEIN CHOICE | |
|---|---|---|---|---|---|---|---|
Rivaroxaban 20 mg | Rivaroxaban 20 mg | Rivaroxaban 10 mg | All Rivaroxaban | Placebo | Aspirin | ||
n=47 | n=159 | n=161 | n=367 | n=48 | n=159 | ||
All patients, N (%) | |||||||
Recurrent VTE | 0 | 1 (0.6) | 2 (1.2) | 3 (0.8) | 4 (8.3) | 8 (5.0) | |
Major bleeding | 0 | 3 (1.9) | 2 (1.2) | 5 (1.4) | 0 | 0 | |
Unprovoked, N (%) | 29 (61.7) | 85 (53.5) | 88 (54.7) | 202 (55.0) | 28 (58.3) | 89 (56.0) | |
Recurrent VTE | 0 | 1 (1.2) | 2 (2.3) | 3 (1.5) | 4 (14.3) | 5 (5.6) | |
Major bleeding | 0 | 2 (2.4) | 0 | 2 (1.0) | 0 | 0 | |
Provoked | Major persistent risk factors, N (%) | 2 (4.3) | 9 (5.7) | 6 (3.7) | 17 (4.6) | 3 (6.3) | 9 (5.7) |
Recurrent VTE | 0 | 0 | 0 | 0 | 0 | 0 | |
Major bleeding | 0 | 0 | 0 | 0 | 0 | 0 | |
Minor persistent risk factors, N %) | 11 (23.4) | 31 (19.5) | 32 (19.9) | 74 (20.2) | 12 (25.0) | 36 (22.6) | |
Recurrent VTE | 0 | 0 | 0 | 0 | 0 | 3 (8.3) | |
Major bleeding | 0 | 1 (3.2) | 0 | 1 (1.4) | 0 | 0 | |
Minor transient risk factors, N (%) | 4 (8.5) | 15 (9.4) | 19 (11.8) | 38 (10.4) | 3 (6.3) | 18 (11.3) | |
Recurrent VTE | 0 | 0 | 0 | 0 | 0 | 0 | |
Major bleeding | 0 | 0 | 1 (5.3) | 1 (2.6) | 0 | 0 | |
Major transient risk factors, N (%) | 1 (2.1) | 19 (11.9) | 16 (9.9) | 36 (9.8) | 2 (4.2) | 7 (4.4) | |
Recurrent VTE | 0 | 0 | 0 | 0 | 0 | 0 | |
Major bleeding | 0 | 0 | 1 (6.3) | 1 (2.8) | 0 | 0 | |