Table 4.

Safety Analysis. Number of Participants With an Adverse Event (Percentage Within Study Population) and Total Number of Adverse Events (Percentage of All Adverse Events in the Respective Category)

	Treatment group, No. (%)
	Sodium oxybate		Placebo
Adverse events	Participants n = 12	Events n = 25	Participants n = 12	Events n = 2	p
Any adverse event‡	9 (75)	25 (100)	2 (17)	2 (100)	0.004
Not serious	7 (58)	20 (80)	2 (17)	2 (100)	0.037
Serious	5 (42)	5 (20)	0	0
Unrelated to study medication†	1 (8)	1 (4)	0	0
Potentially related to study medication	9 (75)	24 (96)	2 (17)	2 (100)	0.004
Mild intensity	6 (50)	16 (64)	0	0
Moderate intensity	3 (25)	5 (25)	2 (17)	2 (100)	0.478
Severe intensity	2 (17)	3 (12)	0	0
Improvement after dose adjustment or spontaneously	7 (58)	16 (64)	0	0
Anxiety	1 (8)	1 (6)	0	0
Asthenia	1 (8)	1 (6)	0	0
Auditory hallucination	1 (8)	1 (6)	0	0
Brain fog	2 (17)	2 (12)	0	0
Enuresis	1 (8)	1 (6)	0	0
Gastrointestinal discomfort	1 (8)	1 (6)	0	0
Headache	1 (8)	1 (6)	0	0
Hot flashes	1 (8)	1 (6)	0	0
Myalgia	1 (8)	1 (6)	0	0
Myoclonus episode*	1 (8)	1 (6)	0	0
Nausea	1 (8)	1 (6)	0	0
Sleep terror*	1 (8)	1 (6)	0	0
Sensation of being “wired”	1 (8)	1 (6)	0	0
Suicidal ideation*	1 (8)	1 (6)	0	0
Tremor	1 (8)	1 (6)	0	0
No improvement after dose adjustment	5 (42)	8 (32)	2 (17)	2 (100)
Anorexia	2 (17)	2 (25)	0	0
Anxiety*	1 (8)	1 (12)	0	0
Catathrenia	1 (8)	1 (12)	0	0
Dizziness*	1 (8)	1 (12)	0	0
Hot flashes	0	0	1 (8)	1 (50)
Increased sweating	2 (17)	2 (25)	0	0
Insomnia	0	0	1 (8)	1 (50)
Dysgeusia	1 (8)	1 (12)	0	0

No, number.

^*: serious adverse event; ^†: daytime sedation; ^‡: Two-sided chi-square or Fisher’s Exact Test testing for group differences in proportion of participants in AE categories where participants are represented in only one of 2 mutually exclusive categories (i.e. serious vs. non-serious AE).