Table 3 Adverse events causally related to treatment (at least possible) reported in at least 2% in any subgroup of patients (sorted by percentages in the 'All patients' 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* | 149 | 25.56 | 46 | 19.25 | 195 | 23.72 |
Insomnia | 48 | 8.23 | 11 | 4.60 | 59 | 7.18 |
Anorexia | 31 | 5.32 | 4 | 1.67 | 35 | 4.26 |
Muscle contractions involuntary | 29 | 4.97 | 5 | 2.09 | 34 | 4.14 |
Medicine ineffective | 13 | 2.23 | 5 | 2.09 | 18 | 2.19 |
Nervousness | 13 | 2.23 | 4 | 1.67 | 17 | 2.07 |
Headache | 10 | 1.72 | 5 | 2.09 | 15 | 1.82 |
Concentration impaired | 7 | 1.20 | 7 | 2.93 | 14 | 1.70 |
Aggressive reaction | 8 | 1.37 | 5 | 2.09 | 13 | 1.58 |
Abdominal pain | 12 | 2.06 | 0 | 0.00 | 12 | 1.46 |
Weight decrease | 4 | 0.69 | 6 | 2.51 | 10 | 1.22 |