Table 3 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%) |