TABLE 4.

Incidence of TEAEs with onset during the treatment period by specific concomitant ASM in patients on one concomitant ASM (safety set)

	Patients on one concomitant ASM
	Concomitant CBZ		Concomitant LTG		Concomitant OXC		Concomitant VPA
	Placebo, n = 34	BRV 50–200 mg/day, n = 54	Placebo, n = 13	BRV 50–200 mg/day, n = 30	Placebo, n = 10	BRV 50–200 mg/day, n = 27	Placebo, n = 15	BRV 50–200 mg/day, n = 27
Any TEAEs	21 (61.8)	38 (70.4)	8 (61.5)	18 (60.0)	5 (50.0)	19 (70.4)	8 (53.3)	16 (59.3)
Drug‐related TEAEs	11 (32.4)	19 (35.2)	6 (46.2)	13 (43.3)	3 (30.0)	13 (48.1)	5 (33.3)	8 (29.6)
Discontinuation due to TEAEs	2 (5.9)	1 (1.9)	0	3 (10.0)	0	2 (7.4)	0	1 (3.7)
Serious TEAEs	1 (2.9)	0	0	1 (3.3)	0	1 (3.7)	0	1 (3.7)
Severe TEAEs	2 (5.9)	4 (7.4)	0	3 (10.0)	1 (10.0)	3 (11.1)	1 (6.7)	1 (3.7)
Deaths	0	1 (1.9)	0	0	0	0	0	1 (3.7)
Incidence of the most common TEAEs a , b
Somnolence	1 (2.9)	10 (18.5)	1 (7.7)	2 (6.7)	1 (10.0)	8 (29.6)	1 (6.7)	2 (7.4)
Headache	2 (5.9)	5 (9.3)	3 (23.1)	3 (10.0)	0	4 (14.8)	0	2 (7.4)
Fatigue	2 (5.9)	3 (5.6)	1 (7.7)	2 (6.7)	0	2 (7.4)	0	0
Dizziness	0	6 (11.1)	1 (7.7)	2 (6.7)	2 (20.0)	1 (3.7)	0	0
Incidence of TEAEs a , c classified as psychiatric disorders d
Insomnia	0	1 (1.9)	0	2 (6.7)	0	0	0	0
Anxiety	0	0	0	1 (3.3)	0	1 (3.7)	0	0
Depression	0	0	0	0	0	0	0	1 (3.7)
Incidence of TEAEs a , c potentially associated with behavioral disorders e
Irritability	1 (2.9)	2 (3.7)	1 (7.7)	1 (3.3)	0	1 (3.7)	1 (6.7)	0

Note: Data are presented as n (%) of patients.

Abbreviations: ASM, antiseizure medication; BRV, brivaracetam; CBZ, carbamazepine; LTG, lamotrigine; MedDRA, Medical Dictionary for Regulatory Activities; OXC, oxcarbazepine; TEAE, treatment‐emergent adverse event; VPA, valproate.

^a MedDRA (v15.0) preferred terms.

^b Reported by ≥5% of all patients randomized to BRV.

^c Reported by ≥1% of all patients randomized to BRV.

^d MedDRA system organ class.

^e MedDRA preferred terms selected by medical review.