Table 4.

TEAEs during OLOTTP and SDP, by treatment at study entry (safety population)

	Group A	Group B	Group C	Group D	Total (N = 201)
	SXB only (n = 52)	SXB + other anticataplectics (n = 23)	Other anticataplectics (n = 36)	Anticataplectic naive (n = 90)
Participants with ≥ 1 TEAE	30 (57.7)	20 (87.0)	30 (83.3)	72 (80.0)	152 (75.6)
TEAEs leading to discontinuation	2 (3.8)	5 (21.7)	6 (16.7)	8 (8.9)	21 (10.4)
Cataplexy	0	4 (17.4)	3 (8.3)	0	7 (3.5)
Nausea	0	0	1 (2.8)	2 (2.2)	3 (1.5)
Anxiety	0	0	0	2 (2.2)	2 (1.0)
Depressed mood	0	0	1 (2.8)	1 (1.1)	2 (1.0)
Depression	0	0	0	2 (2.2)	2 (1.0)
Headache	1 (1.9)	0	0	1 (1.1)	2 (1.0)
Irritability	0	0	0	2 (2.2)	2 (1.0)
Abnormal sleep-related event	0	0	1 (2.8)	0	1 (0.5)
Bile duct stone	0	0	0	1 (1.1)	1 (0.5)
Cognitive disorder	1 (1.9)	0	0	0	1 (0.5)
Decreased appetite	0	0	0	1 (1.1)	1 (0.5)
Fatigue	0	0	1 (2.8)	0	1 (0.5)
Pain in extremity	0	0	0	1 (1.1)	1 (0.5)
Sleep talking	0	0	1 (2.8)	0	1 (0.5)
Sleep-related eating disorder	0	1 (4.3)	0	0	1 (0.5)
Somnolence	0	0	0	1 (1.1)	1 (0.5)
Viral cardiomyopathy	0	0	1 (2.8)	0	1 (0.5)
Vomiting	0	0	0	1 (1.1)	1 (0.5)
TEAEs in ≥ 5% of total participants
Headache	8 (15.4)	3 (13.0)	7 (19.4)	24 (26.7)	42 (20.9)
Nausea	2 (3.8)	1 (4.3)	7 (19.4)	16 (17.8)	26 (12.9)
Dizziness	1 (1.9)	1 (4.3)	6 (16.7)	13 (14.4)	21 (10.4)
Cataplexya	0	11 (47.8)	6 (16.7)	2 (2.2)	19 (9.5)
Decreased appetite	0	1 (4.3)	2 (5.6)	12 (13.3)	15 (7.5)
Influenza	5 (9.6)	3 (13.0)	3 (8.3)	3 (3.3)	14 (7.0)
Nasopharyngitis	2 (3.8)	1 (4.3)	4 (11.1)	6 (6.7)	13 (6.5)
Diarrhea	4 (7.7)	0	0	7 (7.8)	11 (5.5)
Vomiting	1 (1.9)	0	4 (11.1)	5 (5.6)	10 (5.0)

Data presented as n (%)

^aTEAEs of cataplexy were reported when cataplexy worsened compared with the study baseline visit

OLOTTP open-label optimized treatment and titration period, SDP stable-dose period, SXB sodium oxybate, TEAE treatment-emergent adverse event