Table 3.

Secondary Outcome Results for Per-Protocol Population

Secondary Outcome	VT-1161 300 mg q.d., n (%)	VT-1161 600 mg q.d., n (%)	VT-1161 600 mg b.i.d., n (%)	Fluconazole 150 mg, n (%)
Clinical cure (day 28)	n = 8	n = 7	n = 14	n = 8
Yes	6 (75.0)	7 (100.0)	12 (85.7)	5 (62.5)
No	2 (25.0)	0	2 (14.3)	3 (37.5)
95% CI	34.9–96.8	59.0–100.0	57.2–98.2	24.5–91.5
P valuea	.956	.109	.182
Mycological cure (day 7)	n = 8	n = 7	n = 14	n = 8
Yes	8 (100.0)	6 (85.7)	14 (100.0)	8 (100.0)
No	0	1 (14.3)	0	0
95% CI	63.1–100.0	42.1–99.6	76.8–100.0	63.1–100.0
P valuea	–	.414	–
Mycological cure (day 14)	n = 8	n = 7	n = 14	n = 8
Yes	8 (100.0)	6 (85.7)	14 (100.0)	5 (62.5)
No	0	1 (14.3)	0	3 (37.5)
95% CI	63.1–100.0	42.1–99.6	76.8–100.0	24.5–91.5
P valuea	.073	.260	.021
Mycological cure (day 28)	n = 8	n = 7	n = 14	n = 8
Yes	8 (100.0)	6 (85.7)	13 (92.9)	6 (75.0)
No	0	1 (14.3)	1 (7.1)	2 (25.0)
95% CI	63.1–100.0	42.1–99.6	66.1–99.8	34.9–96.8
P valuea	.285	.624	.224
Clinical improvement (day 28)	n = 8	n = 7	n = 14	n = 8
Yes	7 (87.5)	7 (100.0)	12 (85.7)	6 (75.0)
No	1 (12.5)	0	2 (14.3)	2 (25.0)
95% CI	47.3–99.7	59.0–100.0	57.2–98.2	34.9–96.8
P valuea	.621	.221	.495
Clinical relapseb	n = 6	n = 7	n = 12	n = 5
Yes	1 (16.7)	0	1 (8.3)	1 (20.0)
No	5 (83.3)	7 (100)	11 (91.7)	4 (80.0)
Mycological relapsec	n = 8	n = 6	n = 13	n = 6
Yes	0	2 (33.3)	0	4 (66.7)
No	8 (100.0)	4 (66.7)	13 (100.0)	2 (33.3)

Abbreviation: b.i.d., twice daily; CI, confidence interval; q.d., once daily; VT-1161, oteseconazole.

^aP values are from Cochran–Mantel–Haenszel tests comparing each VT-1161 treatment group to fluconazole.

^bn is the number of participants who experienced clinical cure at day 28.

^cn is the number of participants who experienced mycological cure at day 28.