Table 3.
Most Common (>5%) Treatment-Emergent Adverse Events
| Adverse event, n (%) | Optimization/stabilization periods (n = 87) | |
|---|---|---|
| Decreased appetite | 23 (26.4) | |
| Upper abdominal pain | 19 (21.8) | |
| Headache | 17 (19.5) | |
| Insomnia | 11 (12.6) | |
| Upper respiratory tract infection | 10 (11.5) | |
| Affect lability | 8 (9.2) | |
| Irritability | 6 (6.9) | |
| Cough | 5 (5.7) | |
| Vomiting | 5 (5.7) | |
| Double-blind period | ||
| MPH XR-ODT (n = 44) | Placebo (n = 41) | |
|---|---|---|
| Upper respiratory tract infection | 4 (9.1) | 3 (7.3) |
MPH XR-ODT, methylphenidate extended-release orally disintegrating tablet, n, number of participants.