Demographics, clinical presentation, and study treatment at baseline
| Demographics . | Rivaroxaban . | Standard of care . | Total . |
|---|---|---|---|
| N = 40 . | N = 16 . | N = 56 . | |
| Male, n (%) | 20 (50) | 11 (68.8) | 31 (55.4) |
| Bodyweight, mean (interquartile range), kg | 43.1 (20.3-60.8) | 43.5 (26.3-57.8) | 43.3 (21.5-58.9) |
| Creatinine clearance, n (%), mL/min | |||
| 80 | 38 (95) | 15 (93.8) | 53 (94.6) |
| 50 to <80 | 0 (0) | 1 (6.3) | 1 (1.8) |
| Missing | 2 (5) | 0 (0) | 2 (3.6) |
| Concomitant medication, median interquartile range | 30 (20-50) | 28 (19-48) | 30 (20-49) |
| Location of VTE, n (%) | |||
| Upper extremity | 12 (30) | 4 (25) | 16 (28.6) |
| Jugular vein | 7 (17.5) | 3 (18.8) | 10 (17.9) |
| Cerebral vein and sinuses | 7 (17.5) | 2 (12.5) | 9 (16.1) |
| Right heart | 4 (10) | 4 (25) | 8 (14.3) |
| Lower extremity | 5 (12.5) | 2 (12.5) | 7 (12.5) |
| Lung | 3 (7.5) | 1 (6.3) | 4 (7.1) |
| Caval vein | 1 (2.5) | 0 (0) | 1 (1.8) |
| Portal vein | 1 (2.5) | 0 (0) | 1 (1.8) |
| Additional risk factors, n (%) | |||
| Major surgery | 1 (2.5) | 1 (6.3) | 2 (3.6) |
| Prolonged immobilization | 1 (2.5) | 0 (0) | 1 (1.8) |
| Use of estrogens/progestins | 0 (0) | 2 (12.5) | 2 (3.6) |
| Central venous catheter | 22 (55) | 9 (56.3) | 31 (55.4) |
| Hematologic malignancy | 25 (62.5) | 11 (68.8) | 36 (64.3) |
| Acute lymphoblastic leukemia | 15 (37.5) | 8 (50) | 23 (41.1) |
| Acute myeloid leukemia | 1 (2.5) | 0 (0) | 1 (1.8) |
| Hodgkin lymphoma | 5 (12.5) | 2 (12.5) | 7 (12.5) |
| Non-Hodgkin lymphoma | 4 (10) | 1 (6.3) | 5 (8.9) |
| Solid tumor∗ | 15 (37.5) | 5 (31.3) | 20 (35.7) |
| Chemotherapy | 33 (82.5) | 15 (93.8) | 48 (85.7) |
| Asparaginase | 11 (27.5) | 7 (43.8) | 18 (32.1) |
| Corticosteroids | 33 (82.5) | 12 (75) | 45 (80.4) |
| Rivaroxaban group, n (%) | |||
| Tablet formulation | 14 (35) | NA | NA |
| Suspension formulation | 23 (57.5) | NA | NA |
| Standard anticoagulation group, n (%) | |||
| Low-molecular-weight heparin | NA | 13 (81.3) | NA |
| Unfractioned heparin | NA | 1 (6.3) | NA |
| Low-molecular-weight heparin after vitamin K antagonist | NA | 2 (12.5) | NA |
| Demographics . | Rivaroxaban . | Standard of care . | Total . |
|---|---|---|---|
| N = 40 . | N = 16 . | N = 56 . | |
| Male, n (%) | 20 (50) | 11 (68.8) | 31 (55.4) |
| Bodyweight, mean (interquartile range), kg | 43.1 (20.3-60.8) | 43.5 (26.3-57.8) | 43.3 (21.5-58.9) |
| Creatinine clearance, n (%), mL/min | |||
| 80 | 38 (95) | 15 (93.8) | 53 (94.6) |
| 50 to <80 | 0 (0) | 1 (6.3) | 1 (1.8) |
| Missing | 2 (5) | 0 (0) | 2 (3.6) |
| Concomitant medication, median interquartile range | 30 (20-50) | 28 (19-48) | 30 (20-49) |
| Location of VTE, n (%) | |||
| Upper extremity | 12 (30) | 4 (25) | 16 (28.6) |
| Jugular vein | 7 (17.5) | 3 (18.8) | 10 (17.9) |
| Cerebral vein and sinuses | 7 (17.5) | 2 (12.5) | 9 (16.1) |
| Right heart | 4 (10) | 4 (25) | 8 (14.3) |
| Lower extremity | 5 (12.5) | 2 (12.5) | 7 (12.5) |
| Lung | 3 (7.5) | 1 (6.3) | 4 (7.1) |
| Caval vein | 1 (2.5) | 0 (0) | 1 (1.8) |
| Portal vein | 1 (2.5) | 0 (0) | 1 (1.8) |
| Additional risk factors, n (%) | |||
| Major surgery | 1 (2.5) | 1 (6.3) | 2 (3.6) |
| Prolonged immobilization | 1 (2.5) | 0 (0) | 1 (1.8) |
| Use of estrogens/progestins | 0 (0) | 2 (12.5) | 2 (3.6) |
| Central venous catheter | 22 (55) | 9 (56.3) | 31 (55.4) |
| Hematologic malignancy | 25 (62.5) | 11 (68.8) | 36 (64.3) |
| Acute lymphoblastic leukemia | 15 (37.5) | 8 (50) | 23 (41.1) |
| Acute myeloid leukemia | 1 (2.5) | 0 (0) | 1 (1.8) |
| Hodgkin lymphoma | 5 (12.5) | 2 (12.5) | 7 (12.5) |
| Non-Hodgkin lymphoma | 4 (10) | 1 (6.3) | 5 (8.9) |
| Solid tumor∗ | 15 (37.5) | 5 (31.3) | 20 (35.7) |
| Chemotherapy | 33 (82.5) | 15 (93.8) | 48 (85.7) |
| Asparaginase | 11 (27.5) | 7 (43.8) | 18 (32.1) |
| Corticosteroids | 33 (82.5) | 12 (75) | 45 (80.4) |
| Rivaroxaban group, n (%) | |||
| Tablet formulation | 14 (35) | NA | NA |
| Suspension formulation | 23 (57.5) | NA | NA |
| Standard anticoagulation group, n (%) | |||
| Low-molecular-weight heparin | NA | 13 (81.3) | NA |
| Unfractioned heparin | NA | 1 (6.3) | NA |
| Low-molecular-weight heparin after vitamin K antagonist | NA | 2 (12.5) | NA |
NA, not applicable.
Solid tumors in rivaroxaban arm: astrocytoma (n = 1), Ewing sarcoma (n = 1), fibrosarcoma (n = 1), intracardiac germ cell tumor (n = 1), medulloblastoma (n = 2), myxofibrosarcoma (n = 1), nephroblastoma (n = 1), neuroblastoma (n = 1), opticus glioma (n = 1), osteosarcoma (n = 2), and rhabdomyosarcoma (n = 3). Solid tumors in standard of care arm: craniopharyngioma (n = 1), Ewing sarcoma (n = 2), nasopharynx cancer (n = 1), and oligodendroglioma (n = 1).