Baseline characteristics and treatment details of the safety population
| Patient characteristic . | Rivaroxaban . | LWMH/VKA n = 137 . | ||
|---|---|---|---|---|
| 20 mg, n = 135 . | 30 mg, n = 134 . | 40 mg, n = 136 . | ||
| Male sex, n (%) | 64 (47) | 69 (51) | 71 (52) | 73 (53) |
| Age, y (range)* | 58 (22-87) | 57 (18-89) | 60 (22-94) | 57 (21-92) |
| Weight, kg (range) | 80 (45-140) | 81 (40-140) | 81 (37-154) | 79 (41-134) |
| BMI, kg/m2 (range) | 28 (16-47) | 27 (18-53) | 28 (15-45) | 27 (18-39) |
| Active cancer, n (%) | 11 (8) | 14 (10) | 16 (12) | 10 (7) |
| Previous DVT or PE, n (%) | 28 (21) | 25 (19) | 31 (23) | 40 (29) |
| Recent surgery or trauma, n (%) | 26 (19) | 36 (27) | 30 (22) | 33 (24) |
| Recent immobilization for >3 days, n (%) | 18 (13) | 20 (15) | 21 (15) | 18 (13) |
| Most proximal DVT location, n (%) | ||||
| Trifurcation | 8 (6) | 6 (4) | 6 (4) | 4 (3) |
| Popliteal vein | 48 (37) | 46 (35) | 44 (33) | 49 (37) |
| Superficial femoral vein | 31 (24) | 38 (29) | 38 (29) | 32 (24) |
| Common femoral vein | 44 (34) | 42 (32) | 45 (34) | 49 (37) |
| Perfusion defect at baseline, n (%) | 90 (67) | 103 (77) | 91 (67) | 89 (65) |
| Rivaroxaban trough levels at day 43, median (IQR) ng/mL | 32 (19-60) | 47 (24-83) | 50 (31-96) | — |
| Rivaroxaban peak levels at day 84, median (IQR) ng/mL | 244 (175-360) | 293 (184-399) | 365 (205-564) | — |
| Premature discontinuation, n (%) | 17 (13) | 19 (14) | 12 (9) | 15 (11) |
| Adverse event, n (%) | 9 (7) | 7 (5) | 5 (4) | 5 (4) |
| Consent withdrawn, n (%) | 2 (1) | 2 (1) | 2 (1) | 3 (2) |
| Other, n (%) | 6 (4) | 10 (7) | 5 (4) | 7 (5) |
| Patient characteristic . | Rivaroxaban . | LWMH/VKA n = 137 . | ||
|---|---|---|---|---|
| 20 mg, n = 135 . | 30 mg, n = 134 . | 40 mg, n = 136 . | ||
| Male sex, n (%) | 64 (47) | 69 (51) | 71 (52) | 73 (53) |
| Age, y (range)* | 58 (22-87) | 57 (18-89) | 60 (22-94) | 57 (21-92) |
| Weight, kg (range) | 80 (45-140) | 81 (40-140) | 81 (37-154) | 79 (41-134) |
| BMI, kg/m2 (range) | 28 (16-47) | 27 (18-53) | 28 (15-45) | 27 (18-39) |
| Active cancer, n (%) | 11 (8) | 14 (10) | 16 (12) | 10 (7) |
| Previous DVT or PE, n (%) | 28 (21) | 25 (19) | 31 (23) | 40 (29) |
| Recent surgery or trauma, n (%) | 26 (19) | 36 (27) | 30 (22) | 33 (24) |
| Recent immobilization for >3 days, n (%) | 18 (13) | 20 (15) | 21 (15) | 18 (13) |
| Most proximal DVT location, n (%) | ||||
| Trifurcation | 8 (6) | 6 (4) | 6 (4) | 4 (3) |
| Popliteal vein | 48 (37) | 46 (35) | 44 (33) | 49 (37) |
| Superficial femoral vein | 31 (24) | 38 (29) | 38 (29) | 32 (24) |
| Common femoral vein | 44 (34) | 42 (32) | 45 (34) | 49 (37) |
| Perfusion defect at baseline, n (%) | 90 (67) | 103 (77) | 91 (67) | 89 (65) |
| Rivaroxaban trough levels at day 43, median (IQR) ng/mL | 32 (19-60) | 47 (24-83) | 50 (31-96) | — |
| Rivaroxaban peak levels at day 84, median (IQR) ng/mL | 244 (175-360) | 293 (184-399) | 365 (205-564) | — |
| Premature discontinuation, n (%) | 17 (13) | 19 (14) | 12 (9) | 15 (11) |
| Adverse event, n (%) | 9 (7) | 7 (5) | 5 (4) | 5 (4) |
| Consent withdrawn, n (%) | 2 (1) | 2 (1) | 2 (1) | 3 (2) |
| Other, n (%) | 6 (4) | 10 (7) | 5 (4) | 7 (5) |
BMI indicates body mass index; IQR, interquartile range; and —, not applicable.