| MedDRA System Organ Class/Preferred Term |
Overall |
Group A |
Group B |
| Dapivirine Vaginal Ring (N=36) |
Placebo Vaginal Ring (N=12) |
Dapivirine Vaginal Ring (N=18) |
Placebo Vaginal Ring (N=6) |
Dapivirine Vaginal Ring (N=18) |
Placebo Vaginal Ring (N=6) |
| |
n (%) |
n (%) |
n (%) |
n (%) |
n (%) |
n (%) |
| Participants with one or more events |
32 (88.9) |
11 (91.7) |
17 (94.4) |
5 (83.3) |
15 (83.3) |
6 (100) |
| All Local TEAEs: |
|
|
|
|
|
|
| Reproductive system and breast disorders |
| Dysmenorrhoea |
0 |
1 (8.3) |
0 |
0 |
0 |
1 (16.7) |
| Metrorrhagia |
21 (58.3) |
9 (75.0) |
11 (61.1) |
5 (83.3) |
10 (55.6) |
4 (66.7) |
| Vaginal discharge |
3 (8.3) |
2 (16.7) |
1 (5.6) |
1 (16.7) |
2 (11.1) |
1 (16.7) |
| Vaginal pain |
1 (2.8) |
0 |
1 (5.6) |
0 |
0 |
0 |
| Vulvovaginal discomfort |
4 (11.1) |
1 (8.3) |
2 (11.1) |
0 |
2 (11.1) |
1 (16.7) |
| Vulvovaginal dryness |
1 (2.8) |
0 |
1 (5.6) |
0 |
0 |
0 |
| Vulvovaginal pruritus |
2 (5.6) |
0 |
1 (5.6) |
0 |
1 (5.6) |
0 |
| Infections and Infestations |
| Chlamydial infection |
0 |
1 (8.3) |
0 |
0 |
0 |
1 (16.7) |
| Vaginal candidiasis |
1 (2.8) |
0 |
1 (5.6) |
0 |
0 |
0 |
| Other TEAEs Occurring in 10% or More of the Participants in any for the Dapivirine Arms: |
| Gastrointestinal disorders |
|
|
|
|
|
|
| Abdominal pain |
4 (11.1) |
5 (41.7) |
2 (11.1) |
2 (33.3) |
2 (11.1) |
3 (50.0) |
| Abdominal pain lower |
4 (11.1) |
4 (33.3) |
3 (16.7) |
1 (16.7) |
1 (5.6) |
3 (50.0) |
| Dyspepsia |
4 (11.1) |
1 (8.3) |
4 (22.2) |
0 |
0 |
1 (16.7) |
| Nausea |
5 (13.9) |
1 (8.3) |
3 (16.7) |
0 |
2 (11.1) |
1 (16.7) |
| General disorders and administration site conditions |
| Influenza like illness |
3 (8.3) |
0 |
2 (11.1) |
0 |
1 (5.6) |
0 |
| Musculoskeletal and connective tissue disorders |
| Back pain |
2 (5.6) |
0 |
2 (11.1) |
0 |
0 |
0 |
| Neck pain |
3 (8.3) |
0 |
3 (16.7) |
0 |
0 |
0 |
| Nervous system disorders |
|
|
|
|
|
|
| Headache |
14 (38.9) |
6 (50.0) |
7 (38.9) |
3 (50.0) |
7 (38.9) |
3 (50.0) |
| Presyncope |
2 (5.6) |
0 |
0 |
0 |
2 (11.1) |
0 |
| Somnolence |
2 (5.6) |
0 |
2 (11.1) |
0 |
0 |
0 |
| Renal and urinary disorders |
|
|
|
|
|
|
| Dysuria |
2 (5.6) |
1 (8.3) |
2 (11.1) |
1 (16.7) |
0 |
0 |
| Respiratory, thoracic and mediastinal disorders |
| Pharyngolaryngeal pain |
3 (8.3) |
3 (25.0) |
1 (5.6) |
1 (16.7) |
2 (11.1) |
2 (33.3) |
| Skin and subcutaneous tissue disorders |
| Rash |
2 (5.6) |
0 |
0 |
0 |
2 (11.1) |
0 |
