An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe

Table 5 Total number of women experiencing adverse events (n), number of AEs (#), and number of AEs per 100 person weeks, by regimen

	Continuous regimen (n = 80)*				Precoital regimen (n = 83)*				Observation (n = 20)*
	n	#	#/100 woman weeks	p ¹	N	#	#/100 woman weeks	p ²	n	#	#/100 woman weeks
Total	28	38	23.8	0.60	32	39	23.5	1.00	11	13	16.3
Reproductive tract (RT) or urinary tract (UT) related	12	15	9.4	0.42	8	10	6.0	1.00	4	4	5.0
Severity
Mild	20	23	14.4	0.86	22	27	16.3	0.62	10	11	13.8
RT/UT related	5	6	3.8	0.75	7	8	4.8	1.00	3	3	3.8
Moderate	11	15	9.4	1.00	10	12	7.2	0.23	2	2	2.5
RT/UT related	7	9	5.6	0.07	1	2	1.2	1.00	1	1	1.3
Severe	0	0	-	-	0	0	-	-	0	0	-
RT/UT related	0	0	-	-	0	0	-	-	0	0	-
Relatedness to study products
Definitely	0	0	-	-	0	0	-	-	-	0	-
Probably	4	4	2.5	0.73	6	6	3.6	-	-	0	-
Possibly	6	9	5.6	0.75	4	4	2.4	-	-	0	-
Probably not	4	4	2.5	1.00	4	4	2.4	-	-	0	-
Not related	14	21	13.1	0.21	21	25	15.1	-	-	13	-

* Duet use participants were followed for up to 14 days per regimen. Observation group participants were followed for up to 28 days.
¹ P value for the comparison of the proportion of intervention group women reporting an event during the continuous vs. precoital regimen periods (McNemar's test)
² P value for the comparison of the proportion of women reporting an event between those in an intervention group vs. observational controls (Fisher's exact test)