Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Patients with AEs up to month 12 (safety population)
| AE | Observation group (n = 11) | Control group (n = 11) |
|---|---|---|
| Overall | 7 (63.6%) | 11 (100%) |
| AEs | ||
| Pyrexia | 3 (27.3%) | 4 (36.4%) |
| Perianal pain | 7 (63.6%) | 11 (100%) |
| Anal abscess/fistula | 3 (27.3%) | 5 (45.5%) |
| Fatigue | 4 (36.4%) | 8 (72.7%) |
| AEs leading to study withdrawal | 2 (18.2%) | 3 (27.3%) |
| Treatment-related AEs | 0 (0%) | 11 (100%) |
| Perianal pain | 0 (0%) | 11 (100%) |
| Anal abscess/fistula | 0 (0%) | 1 (9.1%) |
| Serious AEs | 0 (0%) | 0 (0%) |
