Table 3.

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.