Summary of adverse events, and adverse events occurring in ≥5% of children in either treatment group (treated set)
| . | Dabigatran . | Total, N = 203 . | ||
|---|---|---|---|---|
| 12 to <18 y, n = 153 . | 2 to <12 y, n = 42 . | 0 to <2 y, n = 8 . | ||
| Children with any adverse event, n (%) | 120 (78.4) | 25 (59.5) | 7 (87.5) | 152 (74.9) |
| Drug-related adverse event* | 37 (24.2) | 5 (11.9) | 1 (12.5) | 43 (21.2) |
| Children with serious adverse events,† n (%) | 19 (12.4) | 6 (14.3) | 0 | 25 (12.3) |
| Leading to death | 0 | 0 | 0 | 0 |
| Life-threatening | 2 (1.3) | 0 | 0 | 2 (1.0) |
| Requiring hospitalization | 17 (11.1) | 6 (14.3) | 0 | 23 (11.3) |
| Prolonging hospitalization | 1 (0.7) | 1 (2.4) | 0 | 2 (1.0) |
| Other | 2 (1.3) | 2 (4.8) | 0 | 4 (2.0) |
| Children with adverse events of special interest‡ | 0 | 0 | 0 | 0 |
| Children with adverse events leading to treatment discontinuation | 9 (5.9) | 2 (4.8) | 1 (12.5) | 12 (5.9) |
| Adverse events in ≥5% of children overall, n (%) | ||||
| Nasopharyngitis | 26 (17.0) | 7 (16.7) | 1 (12.5) | 34 (16.7) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious adverse event | 0 | 0 | 0 | 0 |
| Headache | 27 (17.6) | 6 (14.3) | 0 | 33 (16.3) |
| Drug-related | 2 (1.3) | 1 (2.4) | 0 | 3 (1.5) |
| Serious | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Abdominal pain§ | 19 (12.4) | 2 (4.8) | 0 | 21 (10.3) |
| Drug-related | 5 (3.3) | 2 (4.8) | 0 | 7 (3.4) |
| Serious | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Respiratory tract infection|| | 15 (9.8) | 3 (7.1) | 0 | 18 (8.9) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Nausea | 13 (8.5) | 3 (7.1) | 0 | 16 (7.9) |
| Drug-related | 5 (3.3) | 2 (4.8) | 0 | 7 (3.4) |
| Serious | 0 | 0 | 0 | 0 |
| Vomiting | 10 (6.5) | 4 (9.5) | 0 | 14 (6.9) |
| Drug-related | 1 (0.7) | 1 (2.4) | 0 | 2 (1.0) |
| Serious | 0 | 0 | 0 | 0 |
| Cough | 9 (5.9) | 4 (9.5) | 1 (12.5) | 14 (6.9) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 0 | 0 |
| Dyspepsia | 13 (8.5) | 0 | 0 | 13 (6.4) |
| Drug-related | 9 (5.9) | 0 | 0 | 9 (4.4) |
| Serious | 0 | 0 | 0 | 0 |
| Pyrexia | 11 (7.2) | 2 (4.8) | 0 | 13 (6.4) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 0 | 0 |
| Diarrhea | 12 (7.8) | 1 (2.4) | 0 | 13 (6.4) |
| Drug-related | 2 (1.3) | 0 | 0 | 2 (1.0) |
| Serious | 0 | 0 | 0 | 0 |
| Pain in extremity | 11 (7.2) | 2 (4.8) | 0 | 13 (6.4) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Epistaxis | 10 (6.5) | 1 (2.4) | 1 (12.5) | 12 (5.9) |
| Drug-related | 5 (3.3) | 1 (2.4) | 1 (12.5) | 7 (3.4) |
| Serious | 0 | 0 | 0 | 0 |
| . | Dabigatran . | Total, N = 203 . | ||
|---|---|---|---|---|
| 12 to <18 y, n = 153 . | 2 to <12 y, n = 42 . | 0 to <2 y, n = 8 . | ||
| Children with any adverse event, n (%) | 120 (78.4) | 25 (59.5) | 7 (87.5) | 152 (74.9) |
| Drug-related adverse event* | 37 (24.2) | 5 (11.9) | 1 (12.5) | 43 (21.2) |
| Children with serious adverse events,† n (%) | 19 (12.4) | 6 (14.3) | 0 | 25 (12.3) |
| Leading to death | 0 | 0 | 0 | 0 |
| Life-threatening | 2 (1.3) | 0 | 0 | 2 (1.0) |
| Requiring hospitalization | 17 (11.1) | 6 (14.3) | 0 | 23 (11.3) |
| Prolonging hospitalization | 1 (0.7) | 1 (2.4) | 0 | 2 (1.0) |
| Other | 2 (1.3) | 2 (4.8) | 0 | 4 (2.0) |
| Children with adverse events of special interest‡ | 0 | 0 | 0 | 0 |
| Children with adverse events leading to treatment discontinuation | 9 (5.9) | 2 (4.8) | 1 (12.5) | 12 (5.9) |
| Adverse events in ≥5% of children overall, n (%) | ||||
| Nasopharyngitis | 26 (17.0) | 7 (16.7) | 1 (12.5) | 34 (16.7) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious adverse event | 0 | 0 | 0 | 0 |
| Headache | 27 (17.6) | 6 (14.3) | 0 | 33 (16.3) |
| Drug-related | 2 (1.3) | 1 (2.4) | 0 | 3 (1.5) |
| Serious | 0 | 1 (2.4) | 0 | 1 (0.5) |
| Abdominal pain§ | 19 (12.4) | 2 (4.8) | 0 | 21 (10.3) |
| Drug-related | 5 (3.3) | 2 (4.8) | 0 | 7 (3.4) |
| Serious | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Respiratory tract infection|| | 15 (9.8) | 3 (7.1) | 0 | 18 (8.9) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Nausea | 13 (8.5) | 3 (7.1) | 0 | 16 (7.9) |
| Drug-related | 5 (3.3) | 2 (4.8) | 0 | 7 (3.4) |
| Serious | 0 | 0 | 0 | 0 |
| Vomiting | 10 (6.5) | 4 (9.5) | 0 | 14 (6.9) |
| Drug-related | 1 (0.7) | 1 (2.4) | 0 | 2 (1.0) |
| Serious | 0 | 0 | 0 | 0 |
| Cough | 9 (5.9) | 4 (9.5) | 1 (12.5) | 14 (6.9) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 0 | 0 |
| Dyspepsia | 13 (8.5) | 0 | 0 | 13 (6.4) |
| Drug-related | 9 (5.9) | 0 | 0 | 9 (4.4) |
| Serious | 0 | 0 | 0 | 0 |
| Pyrexia | 11 (7.2) | 2 (4.8) | 0 | 13 (6.4) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 0 | 0 |
| Diarrhea | 12 (7.8) | 1 (2.4) | 0 | 13 (6.4) |
| Drug-related | 2 (1.3) | 0 | 0 | 2 (1.0) |
| Serious | 0 | 0 | 0 | 0 |
| Pain in extremity | 11 (7.2) | 2 (4.8) | 0 | 13 (6.4) |
| Drug-related | 0 | 0 | 0 | 0 |
| Serious | 1 (0.7) | 0 | 0 | 1 (0.5) |
| Epistaxis | 10 (6.5) | 1 (2.4) | 1 (12.5) | 12 (5.9) |
| Drug-related | 5 (3.3) | 1 (2.4) | 1 (12.5) | 7 (3.4) |
| Serious | 0 | 0 | 0 | 0 |
Investigator defined.
A child could be counted in >1 category.
Protocol-defined adverse events of special interest were elevated aspartate aminotransferase and/or alanine aminotransferase more than threefold upper limit of normal combined with an elevation of total bilirubin more than twofold upper limit of normal measured in the same blood draw sample, and an at least twofold increase in creatinine from baseline levels that is above the upper limit of normal.
Includes children with upper abdominal pain.
Includes children with upper respiratory tract infection and viral upper respiratory tract infection.