TABLE 4.

Treatment-emergent adverse events, safety analysis set

		Fezolinetant, n (%)
	Placebo (n = 43), n (%)	15 mg BID (n = 45)	30 mg BID (n = 43)	60 mg BID (n = 45)	90 mg BID (n = 44)	30 mg QD (n = 43)	60 mg QD (n = 45)	120 mg QD (n = 44)
TEAEs	21 (48.8)	20 (44.4)	18 (41.9)	21 (46.7)	19 (43.2)	23 (53.5)	28 (62.2)	22 (50.0)
Serious TEAEs	0	0	0	0	0	0	1 (2.2)a	0
TEAEs leading to permanent discontinuation	1 (2.3)	0	4 (9.3)	5 (11.1)	3 (6.8)	2 (4.7)	3 (6.7)	3 (6.8)
TEAEs leading to treatment interruption	1 (2.3)	0	0	2 (4.4)	3 (6.8)	0	0	1 (2.3)
Any treatment-related TEAEs	3 (7.0)	1 (2.2)	9 (20.9)	8 (17.8)	9 (20.5)	10 (23.3)	12 (26.7)	11 (25.0)
TEAEs occurring in ≥5% in any treatment arm
Headache	2 (4.7)	3 (6.7)	2 (4.7)	2 (4.4)	1 (2.2)	6 (14.0)	3 (6.7)	4 (9.1)
Nausea	1 (2.3)	1 (2.2)	3 (7.0)	3 (6.7)	1 (2.3)	2 (4.7)	3 (6.7)	2 (4.5)
Urinary tract infection	1 (2.3)	2 (4.4)	1 (2.3)	2 (4.4)	2 (4.5)	2 (4.7)	2 (4.4)	3 (6.8)
Diarrhea	1 (2.3)	0	1 (2.3)	2 (4.4)	2 (4.5)	1 (2.3)	3 (6.7)	2 (4.5)
Upper respiratory tract infection	1 (2.3)	2 (4.4)	1 (2.3)	1 (2.2)	1 (2.3)	3 (7.0)	1 (2.2)	1 (2.3)
Fatigue	0	1 (2.2)	1 (2.3)	1 (2.2)	2 (4.5)	0	3 (6.7)	1 (2.3)
Viral upper respiratory tract infection	0	2 (4.4)	1 (2.3)	1 (2.2)	3 (6.8)	0	0	0
Sinusitis	0	0	0	3 (6.7)	0	1 (2.3)	2 (4.4)	0
Cough	0	1 (2.2)	0	1 (2.2)	0	0	3 (6.7)	0

TEAE, treatment-emergent adverse event.

^aSkin squamous cell carcinoma in a participant who had a preexisting skin mass; not considered treatment related.