Baseline risk factors for VTE by age strata
| . | Dabigatran . | Total . | ||
|---|---|---|---|---|
| 12 to <18 y . | 2 to <12 y . | 0 to <2 y . | ||
| Medical history of previous thromboembolic events | n = 150 | n = 41 | n = 8 | N = 199* |
| History of prior VTE event (before the index VTE event in this trial), n (%) | ||||
| Yes | 28 (18.7) | 6 (14.6) | 2 (25.0) | 36 (18.1) |
| No. of prior confirmed VTE events† | ||||
| 2 | 9 (6.0) | 1 (2.4) | 0 | 10 (5.0) |
| 3 | 13 (8.7) | 4 (9.8) | 1 (12.5) | 18 (9.0) |
| 4 | 4 (2.7) | 0 | 0 | 4 (2.0) |
| 5 | 1 (0.7) | 0 | 0 | 1 (0.5) |
| 6 | 1 (0.7) | 1 (2.4) | 1 (12.5) | 3 (1.5) |
| No | 122 (81.3) | 35 (85.4) | 6 (75.0) | 163 (81.9) |
| Previous VTE,‡ n (%) | n = 28 | n = 6 | n = 2 | n = 36 |
| Unprovoked | 21 (75.0) | 3 (50.0) | 1 (50.0) | 25 (69.4) |
| Provoked | 7 (25.0) | 4 (66.7) | 2 (100.0) | 13 (36.1) |
| Postthrombotic syndrome,§ n (%) | 29 (19.3) | 5 (12.2) | 1 (12.5) | 35 (17.6) |
| Medical conditions/circumstances with increased risk of thrombosis, n (%) | n = 150 | n = 41 | n = 8 | N = 199* |
| Congenital heart disease | 6 (4.0) | 3 (7.3) | 3 (37.5) | 12 (6.0) |
| Hematologic cancer | 4 (2.7) | 7 (17.1) | 0 | 11 (5.5) |
| Presence of central venous line | 3 (2.0) | 4 (9.8) | 4 (50.0) | 11 (5.5) |
| Recent immobilization|| | 7 (4.7) | 0 | 0 | 7 (3.5) |
| Any history of solid cancer | 1 (0.7) | 2 (4.9) | 1 (12.5) | 4 (2.0) |
| Presence of other venous or arterial catheter | 2 (1.3) | 1 (2.4) | 0 | 3 (1.5) |
| Hypertension | 3 (2.0) | 0 | 0 | 3 (1.5) |
| Heart failure | 0 | 1 (2.4) | 1 (12.5) | 2 (1.0) |
| History of stroke or transient ischemic attack | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Liver disease (currently not active) | 0 | 0 | 1 (12.5) | 1 (0.5) |
| History of major or clinically relevant bleeding event | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Total parenteral nutrition dependency | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Clinical risk factors requiring secondary VTE prevention, n (%) | n = 153 | n = 42 | n = 8 | N = 203 |
| Inherited thrombophilia¶,# | 79 (51.6) | 11 (26.2) | 1 (12.5) | 91 (44.8) |
| Factor V Leiden mutation** | 32 (20.9) | 2 (4.8) | 0 | 34 (16.7) |
| Prothrombin mutation†† | 15 (9.8) | 2 (4.8) | 0 | 17 (8.4) |
| Antithrombin deficiency | 16 (10.5) | 4 (9.5) | 0 | 20 (9.9) |
| Protein S/C deficiency | 19 (12.4) | 4 (9.5) | 0 | 23 (11.3) |
| Other‡‡ | 20 (13.1) | 2 (4.8) | 1 (12.5) | 23 (11.3) |
| 2 or more thrombophilia conditions | 26 (17.0) | 4 (9.5) | 0 | 30 (14.8) |
| Congenital nephrotic syndrome | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Other conditions requiring secondary VTE prophylaxis, n (%) | n = 153 | n = 42 | n = 8 | N = 203 |
| Antiphospholipid antibodies and/or lupus antibodies | 18 (11.8) | 1 (2.4) | 1 (12.5) | 20 (9.9) |
| Recurrent unprovoked VTE | 21 (13.7) | 7 (16.7) | 1 (12.5) | 29 (14.3) |
| Structural venous abnormality§§ | 20 (13.1) | 6 (14.3) | 0 | 26 (12.8) |
| Any other risk factor requiring secondary prophylaxis | 47 (30.7) | 18 (42.9) | 6 (75.0) | 71 (35.0) |
| . | Dabigatran . | Total . | ||
|---|---|---|---|---|
| 12 to <18 y . | 2 to <12 y . | 0 to <2 y . | ||
| Medical history of previous thromboembolic events | n = 150 | n = 41 | n = 8 | N = 199* |
| History of prior VTE event (before the index VTE event in this trial), n (%) | ||||
| Yes | 28 (18.7) | 6 (14.6) | 2 (25.0) | 36 (18.1) |
| No. of prior confirmed VTE events† | ||||
| 2 | 9 (6.0) | 1 (2.4) | 0 | 10 (5.0) |
| 3 | 13 (8.7) | 4 (9.8) | 1 (12.5) | 18 (9.0) |
| 4 | 4 (2.7) | 0 | 0 | 4 (2.0) |
| 5 | 1 (0.7) | 0 | 0 | 1 (0.5) |
| 6 | 1 (0.7) | 1 (2.4) | 1 (12.5) | 3 (1.5) |
| No | 122 (81.3) | 35 (85.4) | 6 (75.0) | 163 (81.9) |
| Previous VTE,‡ n (%) | n = 28 | n = 6 | n = 2 | n = 36 |
| Unprovoked | 21 (75.0) | 3 (50.0) | 1 (50.0) | 25 (69.4) |
| Provoked | 7 (25.0) | 4 (66.7) | 2 (100.0) | 13 (36.1) |
| Postthrombotic syndrome,§ n (%) | 29 (19.3) | 5 (12.2) | 1 (12.5) | 35 (17.6) |
| Medical conditions/circumstances with increased risk of thrombosis, n (%) | n = 150 | n = 41 | n = 8 | N = 199* |
| Congenital heart disease | 6 (4.0) | 3 (7.3) | 3 (37.5) | 12 (6.0) |
| Hematologic cancer | 4 (2.7) | 7 (17.1) | 0 | 11 (5.5) |
| Presence of central venous line | 3 (2.0) | 4 (9.8) | 4 (50.0) | 11 (5.5) |
| Recent immobilization|| | 7 (4.7) | 0 | 0 | 7 (3.5) |
| Any history of solid cancer | 1 (0.7) | 2 (4.9) | 1 (12.5) | 4 (2.0) |
| Presence of other venous or arterial catheter | 2 (1.3) | 1 (2.4) | 0 | 3 (1.5) |
| Hypertension | 3 (2.0) | 0 | 0 | 3 (1.5) |
| Heart failure | 0 | 1 (2.4) | 1 (12.5) | 2 (1.0) |
| History of stroke or transient ischemic attack | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Liver disease (currently not active) | 0 | 0 | 1 (12.5) | 1 (0.5) |
| History of major or clinically relevant bleeding event | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Total parenteral nutrition dependency | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Clinical risk factors requiring secondary VTE prevention, n (%) | n = 153 | n = 42 | n = 8 | N = 203 |
| Inherited thrombophilia¶,# | 79 (51.6) | 11 (26.2) | 1 (12.5) | 91 (44.8) |
| Factor V Leiden mutation** | 32 (20.9) | 2 (4.8) | 0 | 34 (16.7) |
| Prothrombin mutation†† | 15 (9.8) | 2 (4.8) | 0 | 17 (8.4) |
| Antithrombin deficiency | 16 (10.5) | 4 (9.5) | 0 | 20 (9.9) |
| Protein S/C deficiency | 19 (12.4) | 4 (9.5) | 0 | 23 (11.3) |
| Other‡‡ | 20 (13.1) | 2 (4.8) | 1 (12.5) | 23 (11.3) |
| 2 or more thrombophilia conditions | 26 (17.0) | 4 (9.5) | 0 | 30 (14.8) |
| Congenital nephrotic syndrome | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Other conditions requiring secondary VTE prophylaxis, n (%) | n = 153 | n = 42 | n = 8 | N = 203 |
| Antiphospholipid antibodies and/or lupus antibodies | 18 (11.8) | 1 (2.4) | 1 (12.5) | 20 (9.9) |
| Recurrent unprovoked VTE | 21 (13.7) | 7 (16.7) | 1 (12.5) | 29 (14.3) |
| Structural venous abnormality§§ | 20 (13.1) | 6 (14.3) | 0 | 26 (12.8) |
| Any other risk factor requiring secondary prophylaxis | 47 (30.7) | 18 (42.9) | 6 (75.0) | 71 (35.0) |
Medical history of previous VTE was collected starting clinical report form version 2; missing data for 4 children who were assessed with clinical report form version 1.
Includes the most recent VTE event.
Children may be counted in >1 category. Percentages based on the number of patients with a history of prior VTE events. Missing data for 163 children.
Missing data for 1 adolescent.
Illness requiring bed rest or involving paralysis.
The number of children with ≥1 of the conditions listed.
Missing data for 2 adolescents and 2 children ages 2 to <12 years.
Gln506 (rs6025), hetero- or homozygous.
G20210A mutation.
Other coagulation disorders/thrombophilias including: MTHFR mutation, methionine synthase reductase mutation, plasminogen activator inhibitor 4G/5G polymorphism, factor XII deficiency, integrin A2 mutation, hyperhomocysteinemia, fibrinogen mutation, glycoprotein IA mutation, glycoprotein IIIA mutation, factor VIII elevation.
Structurally abnormal venous system, for example, inferior vena cava malformation, Paget-Schroetter disease (thoracic outlet syndrome), May-Thurner syndrome (iliac vein compression syndrome).