Table 1. Moderate and severe adverse events among all participants with device placement (N = 427), by type of site1.
| Fixed Site (N = 111) | Mobile Site (N = 316) | Total (N = 427) | ||||||||||
| AE Onset Time/Classified AE Term2/Severity3 | Num of Events | Num of Men | Percent of Men | Exact 95% CI | Num of Events | Num of Men | Percent of Men | Exact 95% CI | Num of Events | Num of Men | Percent of Men | Exact 95% CI |
| MODERATE | ||||||||||||
| … Device displacement | 3 | 3 | (2.7) | (0.6–7.7) | 2 | 2 | (0.6) | (0.1–2.3) | 5 | 5 | (1.2) | (0.4–2.7) |
| … Foreskin detachment | 0 | 0 | (0.0) | (0.0–3.7) | 2 | 2 | (0.6) | (0.1–2.3) | 2 | 2 | (0.5) | (0.1–1.7) |
| … Early device removal (before Day 7) | 0 | 0 | (0.0) | (0.0–3.7) | 2 | 2 | (0.6) | (0.1–2.3) | 2 | 2 | (0.5) | (0.1–1.7) |
| … Edema | 2 | 2 | (1.8) | (0.2–6.4) | 0 | 0 | (0.0) | (0.0–1.2) | 2 | 2 | (0.5) | (0.1–1.7) |
| … Excessive bleeding | 1 | 1 | (0.9) | (0.0–4.9) | 1 | 1 | (0.3) | (0.0–1.8) | 2 | 2 | (0.5) | (0.1–1.7) |
| … Insufficient skin removed | 1 | 1 | (0.9) | (0.0–4.9) | 8 | 8 | (2.5) | (1.1–4.9) | 9 | 9 | (2.1) | (1.0–4.0) |
| … Pain | 3 | 3 | (2.7) | (0.6–7.7) | 0 | 0 | (0.0) | (0.0–1.2) | 3 | 3 | (0.7) | (0.2–2.0) |
| … Wound dehiscence | 1 | 1 | (0.9) | (0.0–4.9) | 0 | 0 | (0.0) | (0.0–1.2) | 1 | 1 | (0.2) | (0.0–1.3) |
| … Poor appearance | 1 | 1 | (0.9) | (0.0–4.9) | 0 | 0 | (0.0) | (0.0–1.2) | 1 | 1 | (0.2) | (0.0–1.3) |
| SEVERE | ||||||||||||
| … Edema | 2 | 2 | (1.8) | (0.2–6.4) | 0 | 0 | (0.0) | (0.0–1.2) | 2 | 2 | (0.5) | (0.1–1.7) |
| TOTAL | 14 | 10 | (9.0) | (4.4–15.9) | 15 | 15 | (4.7) | (2.7–7.1) | 29 | 25 | (5.9) | (3.8–8.5) |
1Includes all events that are at least possibly related to the circumcision procedure.
2More than one AE could be recorded for a given participant.
3Maximum severity.