Table 1 Summary of self-reported symptoms, Colposcopic findings and Laboratory Adverse Experiences
From: Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India
Self-Reported Adverse Experiences Judged Possibly Related to Study Product | ||||
|---|---|---|---|---|
Adverse event | Low-risk cohort N = 30 N (Mild, Moderate) | High-risk cohort N = 12 N (Mild, Moderate) | Total N = 42 (%) | Outcome |
Abdominal pain | 6 (5, 1) | 3 (1, 3) | 9 (21.4%) | Resolved |
Back pain | 3 (3, 0) | 1 (1, 0) | 4 (9.5%) | Resolved |
Dyspareunia | 1 (1, 0) | 0 | 1 (2.4%) | Resolved |
Dysuria | 1 (1, 0) | 0 | 1 (2.4%) | Resolved |
Genito-urinary discomfort* | 2 (2, 0) | 4 (2, 2) | 6 (14.3%) | Resolved |
Colposcopic and Laboratory Adverse Experiences Judged Possibly Related to Study Product | ||||
Adverse event | Low-risk cohort (N = 30) N (Mild, Moderate) | High-risk cohort (N = 12) N (Mild, Moderate) | Total N = 42 (%) | Outcome |
Candidiasis | 2 (0, 2) | 0 | 2 (4.8%) | Resolved |
Cervical Polyp | 2 (2, 0) | 0 | 2 (4.8%) | Continuing** |
Intermenstrual bleeding (IMB) | 2 (2, 0) | 2 (2, 0) | 4 (9.5%) | Resolved |
Abrasion | ||||
Cervical | 0 | 1 (1, 0) | 1 (2.4%) | Resolved |
Vaginal | 1 (1, 0) | 0 | 1 (2.4%) | Resolved |
Increased GGT | 0 | 1 (1, 0) | 1 (2.4%) | Resolved at a follow up after 10 days |
Hyperbilirubinaemia | 2 (2, 0) | 0 | 2 (4.8%) | Continuing** |