Table 2.
Summary of treatment-emergent adverse events (safety population)
| Placebo (N = 121) | Oxtellar XR (SPN-804), mg/day | ||
|---|---|---|---|
| 1200 (N = 122) | 2400 (N = 123) | ||
| Any adverse event, n (%) | 67 (55.4) | 69 (56.6) | 85 (69.1) |
| Serious adverse events, n (%) | 7 (5.8) | 7 (5.7) | 10 (8.1) |
| Adverse events leading to discontinuation, n (%) | 10 (8.3) | 18 (14.8) | 37 (30.1) |
| Incidence, n (%) | |||
| Dizziness | 18 (14.9) | 24 (19.7) | 50 (40.7) |
| Vomiting | 11 (9.1) | 7 (5.7) | 19 (15.4) |
| Headache | 9 (7.4) | 10 (8.2) | 19 (15.4) |
| Somnolence | 11 (9.1) | 14 (11.5) | 17 (13.8) |
| Diplopia | 5 (4.1) | 12 (9.8) | 16 (13.0) |
| Nausea | 14 (11.6) | 14 (11.5) | 15 (12.2) |
| Asthenia | 1 (0.8) | 4 (3.3) | 9 (7.3) |
| Balance disorder | 6 (5.0) | 6 (4.9) | 8 (6.5) |
| Fatigue | 1 (0.8) | 7 (5.7) | 4 (3.3) |
N, total number of patients; n, number of patients.