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) | - | - | - |