Table 3. Treatment-related adverse events.
| Events | Treatment (N = 110) | Placebo (N = 111) | P-value |
|---|---|---|---|
| Subjects with at least one adverse event | 30 (27.3) | 36 (32.4) | 0.463 |
| Most common adverse events (>1%) | |||
| Diarrhea | 18 (16.4) | 21 (18.9) | 0.725 |
| Mild | 16 | 16 | |
| Moderate | 1 | 4 | |
| Severe | 1 | 1 | |
| Flatulence | 14 (12.7) | 18 (16.2) | 0.567 |
| Mild | 10 | 14 | |
| Moderate | 4 | 4 | |
| Nausea | 1 (0.9) | 3 (2.7) | 0.622 |
| Mild | 1 | 3 | |
| Abdominal cramps or stomachache | 0 (0) | 3 (2.7) | 0.247 |
| Moderate | 0 | 2 | |
| Severe | 0 | 1 | |
| Weight gain | 4 (3.6) | 0 (0) | 0.06 |
| Mild | 4 | 0 | |
| Weight loss | 2 (1.8) | 2 (1.8) | 1 |
Data are presented as N (%).