Table 4 Adverse events as reason for study termination reported in at least 1 patient in the total group (sorted by percentages in the total group).
Age | 6-12 years N = 583 | 13-18 years N = 239 | All patients N = 822 | |||
|---|---|---|---|---|---|---|
Adverse event (AE) [preferred term] | n | % | n | % | n | % |
Patients with at least one AE* | 48 | 8.23 | 12 | 5.02 | 60 | 7.30 |
Insomnia | 16 | 2.74 | 3 | 1.26 | 19 | 2.31 |
Anorexia | 6 | 1.03 | 2 | 0.84 | 8 | 0.97 |
Emotional lability | 4 | 0.69 | 3 | 1.26 | 7 | 0.85 |
Muscle contractions involuntary | 6 | 1.03 | 1 | 0.42 | 7 | 0.85 |
Depression | 3 | 0.51 | 3 | 1.26 | 6 | 0.73 |
Abdominal pain | 5 | 0.86 | 0 | 0.00 | 5 | 0.61 |
Aggressive reaction | 4 | 0.69 | 1 | 0.42 | 5 | 0.61 |
Nervousness | 4 | 0.69 | 1 | 0.42 | 5 | 0.61 |
Headache | 1 | 0.17 | 3 | 1.26 | 4 | 0.49 |
Nausea | 3 | 0.51 | 1 | 0.42 | 4 | 0.49 |
Apathy | 1 | 0.17 | 2 | 0.84 | 3 | 0.36 |
Tachycardia | 2 | 0.34 | 1 | 0.42 | 3 | 0.36 |
Anxiety | 2 | 0.34 | 0 | 0.00 | 2 | 0.24 |
Concentration impaired | 1 | 0.17 | 1 | 0.42 | 2 | 0.24 |
Dysphagia | 2 | 0.34 | 0 | 0.00 | 2 | 0.24 |
Weight decrease | 1 | 0.17 | 1 | 0.42 | 2 | 0.24 |