Table 6.

Most frequently reported treatment-emergent adverse events in the double-blind treatment phase of short-term randomized, controlled TRD trials by sex and treatment group

	TRANSFORM-1/TRANSFORM-2				TRANSFORM-3
	Women		Men		Women		Men
	Esketamine + antidepressant N = 237	Antidepressant + placebo N = 144	Esketamine + antidepressant N = 109	Antidepressant +  placebo N = 78	Esketamine + antidepressant N = 45	Antidepressant + placebo N = 40	Esketamine + antidepressant N = 27	Antidepressant + placebo N = 25
Total with AEs	209 (88.2%)	96 (66.7%)	92 (84.4%)	47 (60.3%)	34 (75.6%)	23 (57.5%)	17 (63.0%)	16 (64.0%)
Nausea	72 (30.4%)	11 (7.6%)	26 (23.9%)	8 (10.3%)	9 (20.0%)	3 (7.5%)	4 (14.8%)	0
Headache	52 (21.9%)	21 (14.6%)	18 (16.5%)	17 (21.8%)	6 (13.3%)	1 (2.5%)	3 (11.1%)	1 (4.0%)
Dizziness	53 (22.4%)	10 (6.9%)	29 (26.6%)	5 (6.4%)	13 (28.9%)	4 (10.0%)	2 (7.4%)	1 (4.0%)
Dissociation	68 (28.7%)	7 (4.9%)	24 (22.2%)	1 (1.3%)	7 (15.6%)	1 (2.5%)	2 (7.4%)	0
Vertigo	62 (26.2%)	5 (3.5%)	16 (14.7%)	0	4 (8.9%)	2 (5.0%)	4 (14.8%)	0
Dysgeusia	46 (19.4%)	19 (13.2%)	19 (17.4%)	11 (14.1%)	2 (4.4%)	3 (7.5%)	2 (7.4%)	0
Somnolence	39 (16.5%)	15 (10.4%)	21 (19.3%)	5 (6.4%)	1 (2.2%)	3 (7.5%)	0	0
Paresthesia	31 (13.1%)	2 (1.4%)	12 (11.0%)	2 (2.6%)	2 (4.4%)	2 (5.0%)	2 (7.4%)	0
Anxiety	19 (8.0%)	10 (6.9%)	12 (11.0%)	2 (2.6%)	2 (4.4%)	2 (5.0%)	0	3 (12.0%)
Fatigue	19 (8.0%)	9 (6.3%)	6 (5.5%)	2 (2.6%)	7 (15.6%)	4 (10.0%)	2 (7.4%)	1 (4.0%)
BP increased	16 (6.8%)	3 (2.1%)	14 (12.8%)	2 (2.6%)	8 (17.8%)	3 (7.5%)	1 (3.7%)	0
Hypoesthesia	25 (10.5%)	1 (0.7%)	13 (11.9%)	2 (2.6%)	3 (6.7%)	1 (2.5%)	1 (3.7%)	0
Hypoesthesia oral	29 (12.2%)	2 (1.4%)	8 (7.3%)	1 (1.3%)	4 (8.9%)	0	1 (3.7%)	0
Vomiting	27 (11.4%)	3 (2.1%)	5 (4.6%)	1 (1.3%)	5 (11.1%)	0	0	1 (4.0%)
UTI	6 (2.5%)	2 (1.4%)	0	1 (1.3%)	6 (13.3%)	1 (2.5%)	0	0

The table lists, in descending order of frequency for all patients, all adverse events with an incidence ≥ 10% in any esketamine group

AE adverse event, BP blood pressure, UTI urinary tract infection