Characteristic | Rivaroxaban (n=220) | Standard therapy (n=219) |
---|---|---|
Mean age, years | 58.6 ± 15.8 | 59.0 ± 15.0 |
Male sex, n (%) | 127 (57.7) | 112 (51.1) |
Weight, n (%) | ||
≤50 kg | 11 (5.0) | 15 (6.8) |
>50–80 kg | 182 (82.7) | 188 (85.8) |
>80 kg | 25 (11.4) | 16 (7.3) |
Missing data | 2 (0.9) | 0 |
Creatinine clearance, n (%) | ||
<30 mL/min | 1 (0.5) | 0 |
30–<50 mL/min | 19 (8.6) | 28 (12.8) |
50–<80 mL/min | 75 (34.1) | 72 (32.9) |
≥80 mL/min | 117 (53.2) | 116 (53.0) |
Missing data | 8 (3.6) | 3 (1.4) |
Diagnostic method, PE cohort, n (%) | ||
Spiral computed tomography | 99 (86.8) | 102 (87.9) |
Ventilation–perfusion lung scanning | 11 (9.6) | 10 (8.8) |
Pulmonary angiography | 3 (2.6) | 1 (0.9) |
Not confirmed/not evaluable | 1 (0.9) | 3 (2.6) |
Anatomical extent of PE, n (%) | ||
Limited: ≤25% of vasculature of a single lobe | 13 (11.4) | 10 (8.6) |
Intermediate | 67 (58.8) | 73 (62.9) |
Extensive: multiple lobes and >25% of entire pulmonary vasculature | 30 (26.3) | 29 (25.0) |
Not assessable | 4 (3.5) | 4 (3.4) |
Diagnostic method, DVT cohort, n (%) | ||
Ultrasonography | 130 (90.9) | 120 (89.6) |
Venography | 1 (0.7) | 3 (2.2) |
Computed tomography scan | 4 (2.8) | 1 (0.7) |
Not confirmed/not evaluable | 6 (4.2) | 9 (6.7) |
Anatomical extent of proximal DVT, n (%) | ||
Limited (popliteal vein or more distal) | 25 (17.5) | 17 (12.7) |
Intermediate (most proximal: superficial femoral vein) | 25 (17.5) | 27 (20.1) |
Extensive (most proximal: common femoral or iliac vein) | 112 (78.3) | 108 (80.6) |
Time from onset of symptoms to randomization, days | ||
Median | 9.0 | 9.0 |
Interquartile range | 4.0–19.0 | 4.0–20.0 |
Cause of DVT or PE, n (%) † | ||
Unprovoked | 164 (74.5) | 162 (74.0) |
Secondary DVT or PE | 56 (25.5) | 57 (26.0) |
Recent surgery or trauma | 34 (15.5) | 39 (17.8) |
Immobilization | 21 (9.5) | 24 (11.0) |
Estrogen therapy | 2 (0.9) | 4 (1.8) |
Active cancer | 6 (2.7) | 7 (3.2) |
Puerperium | 2 (0.9) | 4 (1.8) |
Previous DVT or PE | 27 (12.3) | 36 (16.4) |