Table 2.
Summary of AEs reported by adult patients with Lennox–Gastaut syndrome (n = 31)
| Rufinamide (n = 21) | Placebo (n = 10) | |
|---|---|---|
| Patients with any AE, n (%) | 15 (71.4) | 6 (60.0) |
| Patients with any serious AE, n (%) | 0 (0.0) | 0 (0.0) |
| Patients with AEs leading to discontinuation, n (%) | 1 (4.8) | 0 (0.0) |
| AEs reported by >10% patients in either group, n (%) | ||
| Somnolence | 7 (33.3) | 2 (20.0) |
| Vomiting | 4 (19.0) | 0 (0.0) |
| Ecchymosis | 3 (14.3) | 1 (10.0) |
| Fatigue | 3 (14.3) | 0 (0.0) |
| Ataxia | 3 (14.3) | 0 (0.0) |
| Decreased appetite | 3 (14.3) | 0 (0.0) |
| Headache | 2 (9.5) | 2 (20.0) |
| Pyrexia | 0 (0.0) | 2 (20.0) |
AE adverse event