Table 2.
Details of drug-related adverse events
| Number of patients (%) | Cohort 1 (480 mg/day, n = 3) | Cohort 2 (960 mg/day, n = 4) | Cohort 3 1440 mg/day, n = 7) | Total |
|---|---|---|---|---|
| n = 14 | ||||
| Any drug-related adverse event | ||||
| Grade 1 | 1 (33.3) | 4 (100) | 4 (57.1) | 9 (64.3) |
| Grade 2 | 1 (14.3) | 1 (7.1) | ||
| Grade 3 | 1 (14.3) | 1 (7.1) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | ||||
| Grade 1 | 1 (33.3) | 3 (75.0) | 4 (57.1) | 8 (57.1) |
| Grade 3 | 1 (14.3) | 1 (7.1) | ||
| Nausea (Grade 1) | 0 (0.0) | 0 (0.0) | 4 (57.1) | 4 (28.6) |
| Vomiting (Grade 1) | 0 (0.0) | 1 (25.0) | 2 (28.6) | 3 (21.4) |
| Abdominal pain lower (Grade 1) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 1 (7.1) |
| Infections and infestations | ||||
| Urinary tract infection (Grade 1) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 1 (7.1) |
| Metabolism and nutrition disorders | ||||
| Anorexia | ||||
| Grade 1 | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (7.1) |
| Grade 2 | 0 (0.0) | 0 (0.0) | 1 (14.3) | 1 (7.1) |
| Grade 3 | 0 (0.0) | 0 (0.0) | 1 (14.3) | 1 (7.1) |
| Skin and subcutaneous tissue disorders | ||||
| Rash (Grade 1) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 1 (7.1) |