Table 8.
Adverse Events at Baseline and During Treatment with the Three Methylphenidate Preparations in the Safety Analysis Population
| Baseline | Medikinet retard in equivalent daily dose | Medikinet retard in reduced daily dose | Concerta | |
|---|---|---|---|---|
| Number of children and adolescents treated | 113 | 108 | 106 | 110 |
| Number of adverse events | 32 | 41 | 61 | 65 |
| Number of children and adolescents with adverse events | 24 | 33 | 40 | 39 |
| Most common adverse events (n≥5) | ||||
| Headache | 3 | 8 | 3 | 10 |
| Gastrointestinal pain | 3 | 6 | 7 | 5 |
| Decreased appetite | 4 | 3 | 3 | 7 |
| Initial insomnia | 1 | 3 | 3 | 6 |
| Aggression | 1 | 2 | 3 | 5 |
| Fatigue | 2 | 0 | 4 | 3 |
| Disturbance in attention | 0 | 0 | 3 | 5 |
| Restlessness | 0 | 1 | 5 | 2 |
| Anorexia | 3 | 0 | 0 | 4 |
| Nasopharyngitis | 1 | 2 | 2 | 1 |
| Weight loss | 0 | 0 | 3 | 2 |