Baseline patient demographics and characteristics by age strata
| . | Dabigatran . | Total, N = 203 . | ||
|---|---|---|---|---|
| 12 to <18 y, n = 153 . | 2 to <12 y, n = 42 . | 0 to <2 y, n = 8 . | ||
| Dabigatran formulation,*n (%) | ||||
| Capsules | 153 (100.0) | 18 (42.9) | 0 | 171 (84.2) |
| Pellets | 0 | 24 (57.1) | 8 (100.0) | 32 (15.8) |
| Age, mean (SD), y | 15.1 (1.6) | 7.0 (3.0) | 0.6 (0.5) | 12.8 (4.5) |
| Male, n (%) | 87 (56.9) | 21 (50.0) | 5 (62.5) | 113 (55.7) |
| Region, n (%) | ||||
| Central/Eastern Europe | 73 (47.7) | 21 (50.0) | 7 (87.5) | 101 (49.8) |
| Western Europe | 35 (22.9) | 12 (28.6) | 0 | 47 (23.2) |
| North America | 37 (24.2) | 5 (11.9) | 1 (12.5) | 43 (21.2) |
| Latin America | 5 (3.3) | 2 (4.8) | 0 | 7 (3.4) |
| Asia | 2 (1.3) | 1 (2.4) | 0 | 3 (1.5) |
| Israel | 1 (0.7) | 1 (2.4) | 0 | 2 (1.0) |
| Race,† n (%) | ||||
| White | 141 (92.2) | 37 (88.1) | 7 (87.5) | 185 (91.1) |
| Asian | 6 (3.9) | 1 (2.4) | 0 | 7 (3.4) |
| Black or African American | 4 (2.6) | 3 (7.1) | 0 | 7 (3.4) |
| Multiple | 1 (0.7) | 1 (2.4) | 1 (12.5) | 3 (1.5) |
| Body mass index, mean (SD), kg/m2 | 24.7 (5.4) | 17.8 (2.4) | 16.1 (1.2) | 22.9 (5.7) |
| eGFR,‡ mean (SD), mL/min/1.73 m2 | 101.3 (26.6) | 128.5 (25.2) | 125.6 (15.7) | 107.8 (28.3) |
| Source of patients | ||||
| Chronically anticoagulated children newly exposed to dabigatran | 82 (53.6) | 26 (61.9) | 7 (87.5) | 115 (56.7) |
| Rollover patients treated with dabigatran in the DIVERSITY trial | 46 (30.1) | 12 (28.6) | 1 (12.5) | 59 (29.1) |
| Rollover patients treated with SOC in the DIVERSITY trial | 25 (16.3) | 4 (9.5) | 0 | 29 (14.3) |
| Prior anticoagulation treatment,§n (%) | ||||
| LMWH | 116 (75.8) | 29 (69.0) | 7 (87.5) | 152 (74.9) |
| VKA | 61 (39.9) | 11 (26.2) | 1 (12.5) | 73 (36.0) |
| Unfractionated heparin | 46 (30.1) | 10 (23.8) | 2 (25.0) | 58 (28.6) |
| Direct oral anticoagulant|| | 46 (30.1) | 12 (28.6) | 1 (12.5) | 59 (29.1) |
| Fondaparinux | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Other | 14 (9.2) | 1 (2.4) | 0 | 15 (7.4) |
| Most recent venous thromboembolic event,¶n (%) | ||||
| DVT (other than central-line and cerebral venous thrombosis) | 126 (82.4) | 24 (57.1) | 5 (62.5) | 155 (76.4) |
| Pulmonary embolism | 19 (12.4) | 1 (2.4) | 0 | 20 (9.9) |
| Central-line thrombosis | 2 (1.3) | 3 (7.1) | 2 (25.0) | 7 (3.4) |
| Cerebral venous thrombosis and/or sinus thrombosis | 8 (5.2) | 14 (33.3) | 1 (12.5) | 23 (11.3) |
| DVT (other than central-line and cerebral venous thrombosis) or central-line thrombosis | 128 (83.7) | 27 (64.3) | 7 (87.5) | 162 (79.8) |
| Risk factors for VTE, n (%) | ||||
| 1 prespecified# risk factor | 93 (60.8) | 28 (66.7) | 5 (62.5) | 126 (62.1) |
| ≥2 prespecified# risk factor | 50 (32.7) | 9 (21.4) | 2 (25.0) | 61 (30.0) |
| Other risk factors requiring further anticoagulation** | 10 (6.5) | 5 (11.9) | 1 (12.5) | 16 (7.9) |
| . | Dabigatran . | Total, N = 203 . | ||
|---|---|---|---|---|
| 12 to <18 y, n = 153 . | 2 to <12 y, n = 42 . | 0 to <2 y, n = 8 . | ||
| Dabigatran formulation,*n (%) | ||||
| Capsules | 153 (100.0) | 18 (42.9) | 0 | 171 (84.2) |
| Pellets | 0 | 24 (57.1) | 8 (100.0) | 32 (15.8) |
| Age, mean (SD), y | 15.1 (1.6) | 7.0 (3.0) | 0.6 (0.5) | 12.8 (4.5) |
| Male, n (%) | 87 (56.9) | 21 (50.0) | 5 (62.5) | 113 (55.7) |
| Region, n (%) | ||||
| Central/Eastern Europe | 73 (47.7) | 21 (50.0) | 7 (87.5) | 101 (49.8) |
| Western Europe | 35 (22.9) | 12 (28.6) | 0 | 47 (23.2) |
| North America | 37 (24.2) | 5 (11.9) | 1 (12.5) | 43 (21.2) |
| Latin America | 5 (3.3) | 2 (4.8) | 0 | 7 (3.4) |
| Asia | 2 (1.3) | 1 (2.4) | 0 | 3 (1.5) |
| Israel | 1 (0.7) | 1 (2.4) | 0 | 2 (1.0) |
| Race,† n (%) | ||||
| White | 141 (92.2) | 37 (88.1) | 7 (87.5) | 185 (91.1) |
| Asian | 6 (3.9) | 1 (2.4) | 0 | 7 (3.4) |
| Black or African American | 4 (2.6) | 3 (7.1) | 0 | 7 (3.4) |
| Multiple | 1 (0.7) | 1 (2.4) | 1 (12.5) | 3 (1.5) |
| Body mass index, mean (SD), kg/m2 | 24.7 (5.4) | 17.8 (2.4) | 16.1 (1.2) | 22.9 (5.7) |
| eGFR,‡ mean (SD), mL/min/1.73 m2 | 101.3 (26.6) | 128.5 (25.2) | 125.6 (15.7) | 107.8 (28.3) |
| Source of patients | ||||
| Chronically anticoagulated children newly exposed to dabigatran | 82 (53.6) | 26 (61.9) | 7 (87.5) | 115 (56.7) |
| Rollover patients treated with dabigatran in the DIVERSITY trial | 46 (30.1) | 12 (28.6) | 1 (12.5) | 59 (29.1) |
| Rollover patients treated with SOC in the DIVERSITY trial | 25 (16.3) | 4 (9.5) | 0 | 29 (14.3) |
| Prior anticoagulation treatment,§n (%) | ||||
| LMWH | 116 (75.8) | 29 (69.0) | 7 (87.5) | 152 (74.9) |
| VKA | 61 (39.9) | 11 (26.2) | 1 (12.5) | 73 (36.0) |
| Unfractionated heparin | 46 (30.1) | 10 (23.8) | 2 (25.0) | 58 (28.6) |
| Direct oral anticoagulant|| | 46 (30.1) | 12 (28.6) | 1 (12.5) | 59 (29.1) |
| Fondaparinux | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Other | 14 (9.2) | 1 (2.4) | 0 | 15 (7.4) |
| Most recent venous thromboembolic event,¶n (%) | ||||
| DVT (other than central-line and cerebral venous thrombosis) | 126 (82.4) | 24 (57.1) | 5 (62.5) | 155 (76.4) |
| Pulmonary embolism | 19 (12.4) | 1 (2.4) | 0 | 20 (9.9) |
| Central-line thrombosis | 2 (1.3) | 3 (7.1) | 2 (25.0) | 7 (3.4) |
| Cerebral venous thrombosis and/or sinus thrombosis | 8 (5.2) | 14 (33.3) | 1 (12.5) | 23 (11.3) |
| DVT (other than central-line and cerebral venous thrombosis) or central-line thrombosis | 128 (83.7) | 27 (64.3) | 7 (87.5) | 162 (79.8) |
| Risk factors for VTE, n (%) | ||||
| 1 prespecified# risk factor | 93 (60.8) | 28 (66.7) | 5 (62.5) | 126 (62.1) |
| ≥2 prespecified# risk factor | 50 (32.7) | 9 (21.4) | 2 (25.0) | 61 (30.0) |
| Other risk factors requiring further anticoagulation** | 10 (6.5) | 5 (11.9) | 1 (12.5) | 16 (7.9) |
DVT, deep vein thrombosis; eGFR, estimated glomerular filtration rate; SD, standard deviation.
One adolescent was not treated.
Missing data for 1 adolescent.
Calculated using the Schwartz formula.
Nonanticoagulation therapy was used to treat the most recent VTE in 5 adolescents, 2 children aged 2 to <12 years, and 1 child aged from >3 months to <2 years.
Rollover patients treated with dabigatran in the DIVERSITY trial.
Patients could be assessed with >1 type of most recent VTE.
Defined as inherited thrombophilia, short bowel syndrome, congenital nephrotic syndrome, inflammatory bowel disease, recent immobilization, presence of central venous/arterial line or catheter, total parental nutrition, systemic lupus erythematosus, systemic sclerosis or inflammatory vasculopathies, recurrent idiopathic (unprovoked) VTE, structural venous abnormality, antiphospholipid and/or lupus antibodies.
As assessed by investigators, not within prespecified categories of risk factors.