Treatment-emergent adverse events (SS)
| Placebo (n=121) | Lacosamide (n=121) | |
| Any TEAEs, n (%) | 79 (65.3) | 96 (79.3) |
| Drug-related TEAEs* | 42 (34.7) | 56 (46.3) |
| Serious TEAEs | 4 (3.3) | 8 (6.6) |
| Severe TEAEs | 3 (2.5) | 6 (5.0) |
| Discontinuations due to TEAEs | 5 (4.1) | 11 (9.1) |
| TEAEs† experienced during the treatment period by ≥5% of patients in either treatment group, n (%) | ||
| Dizziness | 7 (5.8) | 28 (23.1) |
| Somnolence | 17 (14.0) | 20 (16.5) |
| Headache | 12 (9.9) | 17 (14.0) |
| Nausea | 7 (5.8) | 12 (9.9) |
| Vertigo | 2 (1.7) | 8 (6.6) |
| Nasopharyngitis | 4 (3.3) | 8 (6.6) |
| Fatigue | 6 (5.0) | 8 (6.6) |
| Vomiting | 1 (0.8) | 7 (5.8) |
| Upper respiratory tract infection | 6 (5.0) | 3 (2.5) |
| Drug-related TEAEs*† experienced during the treatment period by ≥5% of patients in either treatment group, n (%) | ||
| Dizziness | 4 (3.3) | 21 (17.4) |
| Somnolence | 14 (11.6) | 16 (13.2) |
| Nausea | 3 (2.5) | 9 (7.4) |
| Vertigo | 2 (1.7) | 7 (5.8) |
| Vomiting | 0 | 6 (5.0) |
| Fatigue | 3 (2.5) | 6 (5.0) |
*TEAEs considered drug-related by the investigator (if relationship to trial medication was missing, TEAE was considered drug related).
†MedDRA (V.16.1) preferred term.
SS, safety set; TEAE, treatment-emergent adverse event.