Table 1.

Summary of Adverse Events (AEs) and Serious Adverse Events (SAE) by Severity

No. (%) of participants with AEs	Dapivirine Ring (N = 73), n (%)	Placebo Ring (N = 23), n (%)	All Participants (N = 96), n (%)
At least one AE	63 (86.3)	22 (95.7)	85 (88.5)
Primary end point
Grade 2 related (%, 95% CI)*	8 (11, 5 to 20)	2 (9, 1 to 28)
Grade 3 or higher (%, 95% CI)*	3 (4, 1 to 12)	0 (0 to 15)
By severity (max severity of any AE)
Grade 1: mild	16 (21.9)	10 (43.5)	26 (27.1)
Grade 2: moderate	44 (60.3)	12 (52.2)	56 (58.3)
Grade 3: severe	3 (4.1)	0	3 (3.1)
Grade 4: potentially life threatening	0	0	0
Grade 5: death	0	0	0
At least one product-related AE	23 (31.5)	10 (43.5)	33 (34.4)
At least one AE leading to permanent discontinuation	0	0	0
At least one SAE	2 (2.7)	0	2 (2.1)
SAE by criterion
At least one product-related SAE	0	0	0
Resulted in death	0	0	0
Was life-threatening	0	0	0
Required inpatient hospitalization or prolongation of existing hospitalization	1 (1.4)	0	1 (1.0)
Required procedure or surgery	1 (1.4)	0	1 (1.0)

^*Fisher exact test P value = 1.00.