TABLE 1.
Baseline patient characteristics in the safety analysis set
| Characteristic | Rivaroxaban (n = 3904) | Standard anticoagulation (n = 2551) | P value |
|---|---|---|---|
| Age, y, mean ± SD | 58.0 ± 16.9 | 62.2 ± 17.1 | <.0001 |
| <60 | 1958 (50.2) | 1021 (40.0) | <.0001 |
| ≥60 | 1946 (49.8) | 1530 (60.0) | |
| Sex, male | 2051 (52.5) | 1296 (50.8) | .17 |
| Body weight, kg, mean ± SD | 78.6 ± 18.4 | 79.4 ± 18.1 | .16 |
| <50 kg | 95 (2.4) | 57 (2.2) | NA |
| ≥50 to ≤70 kg | 1037 (26.6) | 671 (26.3) | |
| >70 to <90 kg | 1234 (31.6) | 837 (32.8) | |
| ≥90 kg | 796 (20.4) | 564 (22.1) | |
| Missing | 742 (19.0) | 422 (16.5) | |
| BMI, kg/m2, mean ± SD | 27.4 ± 5.2 | 28.2 ± 6.8 | <.0001 |
| <25 kg/m2 | 975 (25.0) | 499 (19.6) | .007 |
| ≥25 to ≤35 kg/m2 | 1538 (39.4) | 923 (36.2) | |
| >35 kg/m2 | 228 (5.8) | 163 (6.4) | |
| Missing | 1163 (29.8) | 966 (37.9) | |
| First available CrCl, mL/min, mean ± SD | 97.8 ± 42.3 | 91.9 ± 47.0 | <.0001 |
| <30 mL/min | 35 (0.9) | 80 (3.1) | <.0001 |
| ≥30 to <50 mL/min | 191 (4.9) | 198 (7.8) | |
| ≥50 to <80 mL/min | 694 (17.8) | 488 (19.1) | |
| ≥80 mL/min | 1574 (40.3) | 928 (36.4) | |
| Missing | 1410 (36.1) | 857 (33.6) | |
| Fragile a | 768 (19.7) | 763 (29.9) | <.0001 |
| Type of VTE | .62 | ||
| DVT only | 3281 (84.0) | 2132 (83.6) | |
| PE ± DVT | 623 (16.0) | 419 (16.4) | |
| DVT location | |||
| Upper limb | 168 (4.3) | 158 (6.2) | |
| Lower limb | 3633 (93.1) | 2342 (91.8) | |
| Active cancer | 362 (9.3) | 480 (18.8) | <.0001 |
| Known thrombophilia | 206 (5.3) | 124 (4.9) | .46 |
| AT deficiency | 4 (0.1) | 6 (0.2) | |
| PC deficiency | 46 (1.2) | 24 (0.9) | |
| PS deficiency | 17 (0.4) | 7 (0.3) | |
| aPCR | 9 (0.2) | 4 (0.2) | |
| Lupus anticoagulant | 13 (0.3) | 8 (0.3) | |
| Hyperhomocysteinemia | 12 (0.3) | 8 (0.3) | |
| Factor V Leiden | 75 (1.9) | 50 (2.0) | |
| Prothrombin G20210A | 15 (0.4) | 9 (0.4) | |
| Antiphospholipid antibodies | 12 (0.3) | 13 (0.5) | |
| Other | 35 (0.9) | 19 (0.7) | |
| Provoked VTE | 1376 (35.2) | 1015 (39.8) | .0002 |
| Previous VTE | 780 (20.0) | 536 (21.0) | .31 |
| Previous major bleeding | 65 (1.7) | 73 (2.9) | .001 |
| Geographic region | <.0001 | ||
| Western Europe/Canada/Israel | 2318 (59.4) | 1913 (75.0) | |
| Eastern Europe | 490 (12.6) | 283 (11.1) | |
| Middle East/Africa | 284 (7.3) | 149 (5.8) | |
| Asia‐Pacific | 720 (18.4) | 167 (6.5) | |
| Latin America | 92 (2.4) | 39 (1.5) | |
Data are n (%) unless stated otherwise.
Abbreviations: aPCR, activated protein C resistance; AT, antithrombin; BMI, body mass index; CrCl, creatinine clearance; DVT, deep vein thrombosis; NA, not available; PC, pyruvate carboxylase; PE, pulmonary embolism; PS, protein S; SD, standard deviation; VTE, venous thromboembolism.
a
Fragile patients were defined as aged >75 years old or weight ≤50 kg or first available CrCl <50 mL/min; note that some patients had missing CrCl values.