Table 3.

Treatment‐emergent adverse events reported for ≥ 5% of patients in any treatment arm within 2 days after trial drug administration during the TD (safety population) and CP (randomized safety population)

Preferred term, n (%)	Test dose phase	Comparative phase
	MDZ–NS	MDZ–NS		Placebo
	N = 292	DB only (n = 91)	DB + OL (n = 43)	DB PBO only (n = 26)	DB PBO + OL MDZ–NS (n = 41)
Any TEAE	109 (37.3)	21 (23.1)	13 (30.2)	6 (23.1)	9 (22.0)
Nasal discomfort	47 (16.1)	5 (5.5)	7 (16.3)	2 (7.7)	3 (7.3)
Somnolence	29 (9.9)	9 (9.9)	4 (9.3)	1 (3.8)	4 (9.8)
Lacrimation increased	20 (6.8)	1 (1.1)	1 (2.3)	0	1 (2.4)
Product taste abnormal	17 (5.8)	4 (4.4)	0	0	0
Throat irritation	15 (5.1)	2 (2.2)	3 (7.0)	0	1 (2.4)
Headache	1 (0.3)	6 (6.6)	1 (2.3)	0	0

Adverse events were assigned to TDP if they occurred after administration of test dose and before CP dose, and to CP only at/after the CP dose, not based on randomization.

Abbreviations: DB, double‐blind; MDZ–NS, midazolam nasal spray; OL, open‐label; PBO, placebo; TEAE, treatment‐emergent adverse event.