Baseline patient demographics and clinical characteristics by study, treatment, and thrombophilia status
| . | Acute VTE treatment study (DIVERSITY) . | Secondary VTE prevention study . | ||||||
|---|---|---|---|---|---|---|---|---|
| Thrombophilia negative/unknown . | Thrombophilia documented . | Thrombophilia negative/unknown . | Thrombophilia documented . | |||||
| Dabigatran (N = 138) . | SOC (N = 67) . | Total (N = 205) . | Dabigatran (N = 39) . | SOC (N = 23) . | Total (N = 62) . | Total (N = 107) . | Total (N = 106) . | |
| Age, mean (SD), y | 10.5 (6.1) | 10.4 (6.6) | 10.5 (6.3) | 13.4 (5.3) | 12.9 (4.3) | 13.2 (4.9) | 11.5 (5.2) | 14.1 (3.6) |
| Male, n (%) | 62 (44.9) | 39 (58.2) | 101 (49.3) | 19 (48.7) | 13 (56.5) | 32 (51.6) | 59 (55.1) | 58 (54.7) |
| Race, n (%) | ||||||||
| White | 124 (89.9) | 62 (92.5) | 186 (90.7) | 39 (100.0) | 20 (87.0) | 59 (95.2) | 93 (86.9) | 101 (95.3) |
| Black or African American | 1 (0.7) | 1 (1.5) | 2 (1.0) | 0 | 2 (8.7) | 2 (3.2) | 5 (4.7) | 3 (2.8) |
| Asian | 10 (7.2) | 2 (3.0) | 12 (5.9) | 0 | 1 (4.3) | 1 (1.6) | 5 (4.7) | 2 (1.9) |
| Multiple | 2 (1.4) | 0 | 2 (1.0) | 0 | 0 | 0 | 3 (2.8) | 0 |
| Missing | 1 (0.7) | 2 (3.0) | 3 (1.5) | 0 | 0 | 0 | 1 (0.9) | 0 |
| Body mass index, mean (SD), kg/m2 | 20.3 (5.6) [n = 137] | 19.0 (4.6) | 19.9 (5.3) [n = 204] | 21.4 (5.8) | 23.5 (5.8) | 22.2 (5.8) | 21.8 (5.8) | 24.0 (5.4) |
| Estimated glomerular filtration rate, mean (SD),∗ mL/min per 1.73 m2 | 118.1 (34.8) [n = 137] | 121.5 (35.2) | 119.2 (34.8) [n = 204] | 107.4 (18.8) | 105.6 (28.6) | 106.7 (22.7) | 113.8 (32.2) | 101.4 (22.1) |
| SOC treatment, n (%) | ||||||||
| VKA | NA | 37 (55.2) | 37 (18.0) | NA | 12 (52.2) | 12 (19.4) | NA | NA |
| LMWH | NA | 30 (44.8) | 30 (14.6) | NA | 10 (43.5) | 10 (16.1) | NA | NA |
| Fondaparinux | NA | 0 | 0 | NA | 1 (4.3) | 1 (1.6) | NA | NA |
| Index/most recent VTE event, n (%)† | ||||||||
| DVT | 79 (57.2) | 38 (56.7) | 117 (57.1) | 31 (79.5) | 22 (95.7) | 53 (85.5) | 82 (76.6) | 82 (77.4) |
| PE | 16 (11.6) | 3 (4.5) | 19 (9.3) | 4 (10.3) | 1 (4.3) | 5 (8.1) | 6 (5.6) | 14 (13.2) |
| Central line thrombosis | 26 (18.8) | 20 (29.9) | 46 (22.4) | 1 (2.6) | 0 | 1 (1.6) | 5 (4.7) | 2 (1.9) |
| CVT and/or sinus thrombosis | 17 (12.3) | 6 (9.0) | 23 (11.2) | 3 (7.7) | 0 | 3 (4.8) | 15 (14.0) | 9 (8.5) |
| Days since index VTE until randomization, mean (SD), d | 16.4 (6.9) | 17.4 (5.6) | 16.7 (6.5) | 14.8 (4.9) | 13.5 (5.4) | 14.4 (5.1) | 199.6 (413.3) | 313.3 (444.2) |
| Interventions for index/most recent VTE, n (%) | ||||||||
| Unfractionated heparin | 20 (14.5) | 11 (16.4) | 31 (15.1) | 12 (30.8) | 5 (21.7) | 17 (27.4) | 25 (23.4) | 34 (32.1) |
| LMWH | 130 (94.2) | 63 (94.0) | 193 (94.1) | 35 (89.7) | 20 (87.0) | 55 (88.7) | 81 (75.7) | 82 (77.4) |
| Fondaparinux | 0 | 0 | 0 | 0 | 1 (4.3) | 1 (1.6) | 0 | 1 (0.9) |
| VKA | 0 | 0 | 0 | 0 | 0 | 0 | 38 (35.5) | 42 (39.6) |
| Non-VKA oral anticoagulant | 0 | 0 | 0 | 0 | 0 | 0 | 32 (29.9) | 33 (31.1) |
| Other parenteral anticoagulation | 3 (2.2) | 1 (1.5) | 4 (2.0) | 4 (10.3) | 1 (4.3) | 5 (8.1) | 2 (1.9) | 12 (11.3) |
| Nonanticoagulation therapy | 0 | 1 (1.5) | 1 (0.5) | 0 | 0 | 0 | 6 (5.6) | 3 (2.8) |
| . | Acute VTE treatment study (DIVERSITY) . | Secondary VTE prevention study . | ||||||
|---|---|---|---|---|---|---|---|---|
| Thrombophilia negative/unknown . | Thrombophilia documented . | Thrombophilia negative/unknown . | Thrombophilia documented . | |||||
| Dabigatran (N = 138) . | SOC (N = 67) . | Total (N = 205) . | Dabigatran (N = 39) . | SOC (N = 23) . | Total (N = 62) . | Total (N = 107) . | Total (N = 106) . | |
| Age, mean (SD), y | 10.5 (6.1) | 10.4 (6.6) | 10.5 (6.3) | 13.4 (5.3) | 12.9 (4.3) | 13.2 (4.9) | 11.5 (5.2) | 14.1 (3.6) |
| Male, n (%) | 62 (44.9) | 39 (58.2) | 101 (49.3) | 19 (48.7) | 13 (56.5) | 32 (51.6) | 59 (55.1) | 58 (54.7) |
| Race, n (%) | ||||||||
| White | 124 (89.9) | 62 (92.5) | 186 (90.7) | 39 (100.0) | 20 (87.0) | 59 (95.2) | 93 (86.9) | 101 (95.3) |
| Black or African American | 1 (0.7) | 1 (1.5) | 2 (1.0) | 0 | 2 (8.7) | 2 (3.2) | 5 (4.7) | 3 (2.8) |
| Asian | 10 (7.2) | 2 (3.0) | 12 (5.9) | 0 | 1 (4.3) | 1 (1.6) | 5 (4.7) | 2 (1.9) |
| Multiple | 2 (1.4) | 0 | 2 (1.0) | 0 | 0 | 0 | 3 (2.8) | 0 |
| Missing | 1 (0.7) | 2 (3.0) | 3 (1.5) | 0 | 0 | 0 | 1 (0.9) | 0 |
| Body mass index, mean (SD), kg/m2 | 20.3 (5.6) [n = 137] | 19.0 (4.6) | 19.9 (5.3) [n = 204] | 21.4 (5.8) | 23.5 (5.8) | 22.2 (5.8) | 21.8 (5.8) | 24.0 (5.4) |
| Estimated glomerular filtration rate, mean (SD),∗ mL/min per 1.73 m2 | 118.1 (34.8) [n = 137] | 121.5 (35.2) | 119.2 (34.8) [n = 204] | 107.4 (18.8) | 105.6 (28.6) | 106.7 (22.7) | 113.8 (32.2) | 101.4 (22.1) |
| SOC treatment, n (%) | ||||||||
| VKA | NA | 37 (55.2) | 37 (18.0) | NA | 12 (52.2) | 12 (19.4) | NA | NA |
| LMWH | NA | 30 (44.8) | 30 (14.6) | NA | 10 (43.5) | 10 (16.1) | NA | NA |
| Fondaparinux | NA | 0 | 0 | NA | 1 (4.3) | 1 (1.6) | NA | NA |
| Index/most recent VTE event, n (%)† | ||||||||
| DVT | 79 (57.2) | 38 (56.7) | 117 (57.1) | 31 (79.5) | 22 (95.7) | 53 (85.5) | 82 (76.6) | 82 (77.4) |
| PE | 16 (11.6) | 3 (4.5) | 19 (9.3) | 4 (10.3) | 1 (4.3) | 5 (8.1) | 6 (5.6) | 14 (13.2) |
| Central line thrombosis | 26 (18.8) | 20 (29.9) | 46 (22.4) | 1 (2.6) | 0 | 1 (1.6) | 5 (4.7) | 2 (1.9) |
| CVT and/or sinus thrombosis | 17 (12.3) | 6 (9.0) | 23 (11.2) | 3 (7.7) | 0 | 3 (4.8) | 15 (14.0) | 9 (8.5) |
| Days since index VTE until randomization, mean (SD), d | 16.4 (6.9) | 17.4 (5.6) | 16.7 (6.5) | 14.8 (4.9) | 13.5 (5.4) | 14.4 (5.1) | 199.6 (413.3) | 313.3 (444.2) |
| Interventions for index/most recent VTE, n (%) | ||||||||
| Unfractionated heparin | 20 (14.5) | 11 (16.4) | 31 (15.1) | 12 (30.8) | 5 (21.7) | 17 (27.4) | 25 (23.4) | 34 (32.1) |
| LMWH | 130 (94.2) | 63 (94.0) | 193 (94.1) | 35 (89.7) | 20 (87.0) | 55 (88.7) | 81 (75.7) | 82 (77.4) |
| Fondaparinux | 0 | 0 | 0 | 0 | 1 (4.3) | 1 (1.6) | 0 | 1 (0.9) |
| VKA | 0 | 0 | 0 | 0 | 0 | 0 | 38 (35.5) | 42 (39.6) |
| Non-VKA oral anticoagulant | 0 | 0 | 0 | 0 | 0 | 0 | 32 (29.9) | 33 (31.1) |
| Other parenteral anticoagulation | 3 (2.2) | 1 (1.5) | 4 (2.0) | 4 (10.3) | 1 (4.3) | 5 (8.1) | 2 (1.9) | 12 (11.3) |
| Nonanticoagulation therapy | 0 | 1 (1.5) | 1 (0.5) | 0 | 0 | 0 | 6 (5.6) | 3 (2.8) |