Adverse events
| Adverse event | No. (%) of participants n = 52 | No. (%) of events n = 185 |
|---|---|---|
| Any | 47 (90) | – |
| Grade 1 (mild) | 34 (65) | 144 (77.8) |
| Grade 2 (moderate) | 10 (19) | 38 (20.5) |
| Grade 3 (severe) | 3 (6) | 3 (1.6) |
| Any serious | 1 (2) | 1 (0.5) |
| By relation to study drug | ||
| Possibly | 14 (27) | 26 (14.0) |
| Probably | 9 (17) | 11 (5.9) |
| At least possibly related to study drug | ||
| Nausea | 11 (21) | 12 (6.5) |
| Diarrhea | 6 (12) | 6 (3.2) |
| Headache | 6 (12) | 6 (3.2) |
| Fatigue | 5 (10) | 5 (2.7) |
| Bloating | 2 (4) | 2 (1.1) |
| Vivid dreams | 2 (4) | 2 (1.1) |
| Anorexia | 1 (2) | 1 (0.5) |
| Difficulty sleeping | 1 (2) | 1 (0.5) |
| Flatulence | 1 (2) | 1 (0.5) |
| Itching | 1 (2) | 1 (0.5) |