Table 2. Incidence of adverse events that occurred in at least 5% of participants, regardless of causality.
| MedDRA Preferred Term | Reported Severity (DAIDS Grade) | Ring Intervention Phase | Observation Phase | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Group A | Group B | Total | Group A | Group B | Total | Overall Total | p-value | ||
| N = 87 | N = 71 | N = 158 | N = 79 | N = 82 | N = 161 | N = 169 | |||
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |||
| Participant with any adverse event | 57 (65.5%) | 43 (60.6%) | 100 (63.3%) | 47 (59.5%) | 60 (73.2%) | 107 (66.5%) | 138 (81.7%) | 0.6068 | |
| Vaginal candidiasis | Grade 1, 2 | 12 (13.8%) | 6 (8.5%) | 18 (11.4%) | 8 (10.1%) | 9 (11.0%) | 17 (10.6%) | 32 (18.9%) | 0.8527 |
| Influenza-like illness | Grade 1, 2 | 7 (8.0%) | 5 (7.0%) | 12 (7.6%) | 4 (5.1%) | 12 (14.6%) | 16 (9.9%) | 26 (15.4%) | 0.4142 |
| Metrorrhagia | Grade 1, 2 | 5 (5.7%) | 4 (5.6%) | 9 (5.7%) | 4 (5.1%) | 13 (15.9%) | 17 (10.6%) | 23 (13.6%) | 0.0736 |
| Vaginitis bacterial | Grade 1, 2 | 8 (9.2%) | 7 (9.9%) | 15 (9.5%) | 6 (7.6%) | 7 (8.5%) | 13 (8.1%) | 23 (13.6%) | 0.6374 |
| Headache | Grade 1, 2 | 12 (13.8%) | 1 (1.4%) | 13 (8.2%) | 5 (6.3%) | 5 (6.1%) | 10 (6.2%) | 21 (12.4%) | 0.4913 |
| Gynaecological chlamydia Infection | Grade 1, 2 | 2 (2.3%) | 4 (5.6%) | 6 (3.8%) | 8 (10.1%) | 1 (1.2%) | 9 (5.6%) | 15 (8.9%) | 0.4386 |
| Upper respiratory tract infection | Grade 1, 2 | 4 (4.6%) | 1 (1.4%) | 5 (3.2%) | 1 (1.3%) | 9 (11.0%) | 10 (6.2%) | 15 (8.9%) | 0.1967 |
| Vaginal discharge | Grade 1 | 2 (2.3%) | 5 (7.0%) | 7 (4.4%) | 2 (2.5%) | 1 (1.2%) | 3 (1.9%) | 10 (5.9%) | 0.2059 |
DAIDS = Division of AIDS; MedDRA = Medical Dictionary for Regulatory Activities