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 |
* Chi2- Test: p = 0.144; some patients had more than one AE.