Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine

Table 3

Number of subjects reporting and number of reported TEAEs by treatment, system organ class (SOC), and preferred term (PT) (safety set) .

MedDRA description SOC and PT term	T		R1		R2		P
	AEs	Subjects; (%)	AEs	Subjects; (%)	AEs	Subjects; (%)	AEs	Subjects; (%)
Total number of AEs and of subjects with at least one AE	7	7 (53.8)	9	5 (41.7)	2	2 (16.7)	1	1 (8.3)
General disorders and administration site conditions	3	3 (23.1)	5	4 (33.3)	0	0	0	0
Application site reaction	0	0	4	4 (33.3)	0	0	0	0
Application site pruritus	2	2 (15.4)	1	1 (8.3)	0	0	0	0
Application site pain	1	1 (7.7)	0	0	0	0	0	0
Investigations	0	0	2	2 (16.7)	2	2 (16.7)	1	1 (8.3)
Gardnerella test positive	0	0	1	1 (8.3)	1	1 (8.3)	0	0
Candida test positive	0	0	0	0	1	1 (8.3)	0	0
Chlamydia test positive	0	0	0	0	0	0	1	1 (8.3)
Streptococcus test positive	0	0	1	1 (8.3)	0	0	0	0
Nervous system disorders	4	4 (30.8)	1	1 (8.3)	0	0	0	0
Headache	3	3 (23.1)	1	1 (8.3)	0	0	0	0
Dizziness	1	1 (7.7)	0	0	0	0	0	0
Gastrointestinal disorders	0	0	1	1 (8.3)	0	0	0	0
Nausea	0	0	1	1 (8.3)	0	0	0	0

TEAE: treatment emergent adverse event; AE: adverse event; T: test fixed-dose combination of econazole nitrate 150 mg/benzydamine hydrochloride 6 mg vaginal ovules; R1: reference 1 econazole nitrate 150 mg only ovules; R2: reference 2 benzydamine hydrochloride 6 mg only ovules; P: placebo vaginal ovules. MedDRA version 19.0.