Table 4.
Adverse events in > 3 % of patients
| AEs, n (%) | Safety population (N = 120) |
Pediatric subpopulation (N = 90) |
||
|---|---|---|---|---|
| All Grades | Grade 3 or 4 | All Grades | Grade 3 or 4 | |
| Patients with any AE(s) | 89 (74.2) | 28 (23.3) | 67 (74.4) | 23 (25.5) |
| Preferred term | ||||
| Aphthous stomatitis | 18 (15.0) | 2 (1.7) | 13 (14.4) | 1 (1.1) |
| Pyrexia | 18 (15.0) | 1 (0.8) | 16 (17.8) | 1 (1.1) |
| Bronchitis | 11 (9.2) | 1 (0.8) | 11 (12.2) | 1 (1.1) |
| Stomatitis | 10 (8.3) | 4 (3.3) | 7 (7.8) | 4 (4.4) |
| Cough | 6 (5.0) | - | 5 (5.6) | - |
| Diarrhea | 6 (5.0) | 1 (0.8) | 5 (5.6) | 1 (1.1) |
| Headache | 6 (5.0) | 1 (0.8) | 3 (3.3) | 1 (1.1) |
| Mouth ulceration | 6 (5.0) | - | 5 (5.6) | - |
| Sinusitis | 6 (5.0) | 1 (0.8) | 6 (6.7) | 1 (1.1) |
| Abdominal pain | 5 (4.2) | - | 3 (3.3) | - |
| Blood creatine phosphokinase increased | 5 (4.2) | 1 (0.8) | 3 (3.3) | 1 (1.1) |
| Gastroenteritis | 5 (4.2) | 1 (0.8) | 4 (4.4) | 1 (1.1) |
| Hypercholesterolemia | 5 (4.2) | - | - | - |
| Pharyngitis | 5 (4.2) | - | 5 (5.6) | - |
| Pneumonia | 5 (4.2) | - | 5 (5.6) | - |
| Pneumonitis | 5 (4.2) | - | 5 (5.6) | - |
| Upper respiratory tract infection | 5 (4.2) | - | 4 (4.4) | - |
| Menstruation irregular | 4 (3.3) a | - | 3 (3.3) | - |
| Nasopharyngitis | 4 (3.3) | - | 4 (4.4) | - |
| Otitis media | 4 (3.3) | - | 4 (4.4) | - |
| Urinary tract infection | 4 (3.3) | - | - | - |
AE adverse event
aThis percentage includes all patients as the denominator. If we consider the females with child bearing potential (n = 24), 16.6 % of patients reported menstrual irregular events