Most common phase 2–related adverse events
| Adverse event . | Group 1 (n = 23) . | Group 2 (n = 21) . | Group 3 (n = 24) . | Total (n = 68) . | ||||
|---|---|---|---|---|---|---|---|---|
| % . | Grade 3/4, % . | % . | Grade 3/4, % . | % . | Grade 3/4, % . | % . | Grade 3/4, % . | |
| Fatigue | 26 | 0 | 48 | 0 | 50 | 0 | 41 | 0 |
| Diarrhea | 22 | 0 | 48 | 0 | 54 | 0 | 41 | 0 |
| Neutropenia | 22 | 13 | 33 | 14 | 38 | 25 | 31 | 18 |
| Anemia | 17 | 4 | 29 | 5 | 33 | 13 | 27 | 7 |
| Thrombocytopenia | 26 | 4 | 19 | 5 | 25 | 0 | 24 | 3 |
| Hypertension | 0 | 0 | 43 | 14 | 29 | 4 | 24 | 6 |
| Nausea | 4 | 0 | 43 | 0 | 17 | 4 | 21 | 2 |
| AST level increased | 22 | 4 | 19 | 5 | 13 | 4 | 18 | 4 |
| Headache | 4 | 0 | 33 | 0 | 13 | 0 | 16 | 0 |
| Leukopenia | 4 | 0 | 24 | 14 | 8 | 8 | 12 | 7 |
| Dizziness | 0 | 0 | 19 | 0 | 13 | 0 | 10 | 0 |
| Frequent bowel movements | 0 | 0 | 14 | 0 | 17 | 0 | 10 | 0 |
| Dysgeusia | 9 | 0 | 19 | 0 | 4 | 0 | 10 | 0 |
| ALT level increased | 9 | 4 | 14 | 5 | 8 | 4 | 10 | 4 |
| Dyspnea | 4 | 0 | 14 | 0 | 13 | 0 | 10 | 0 |
| Pyrexia | 13 | 0 | 5 | 0 | 8 | 0 | 9 | 0 |
| Blood alkaline phosphatase level increased | 9 | 0 | 14 | 5 | 4 | 0 | 9 | 2 |
| Febrile neutropenia | 4 | 4 | 5 | 0 | 13 | 8 | 7 | 4 |
| Upper abdominal pain | 0 | 0 | 5 | 0 | 17 | 4 | 7 | 2 |
| Dyspepsia | 4 | 0 | 14 | 0 | 4 | 0 | 7 | 0 |
| Increased appetite | 4 | 0 | 10 | 0 | 8 | 0 | 7 | 0 |
| Vomiting | 0 | 0 | 10 | 0 | 8 | 4 | 6 | 2 |
| Flatulence | 0 | 0 | 14 | 0 | 4 | 0 | 6 | 0 |
| Cough | 9 | 0 | 5 | 0 | 4 | 0 | 6 | 0 |
| Blood bilirubin level increased | 4 | 0 | 5 | 0 | 0 | 0 | 6 | 0 |
| Adverse event . | Group 1 (n = 23) . | Group 2 (n = 21) . | Group 3 (n = 24) . | Total (n = 68) . | ||||
|---|---|---|---|---|---|---|---|---|
| % . | Grade 3/4, % . | % . | Grade 3/4, % . | % . | Grade 3/4, % . | % . | Grade 3/4, % . | |
| Fatigue | 26 | 0 | 48 | 0 | 50 | 0 | 41 | 0 |
| Diarrhea | 22 | 0 | 48 | 0 | 54 | 0 | 41 | 0 |
| Neutropenia | 22 | 13 | 33 | 14 | 38 | 25 | 31 | 18 |
| Anemia | 17 | 4 | 29 | 5 | 33 | 13 | 27 | 7 |
| Thrombocytopenia | 26 | 4 | 19 | 5 | 25 | 0 | 24 | 3 |
| Hypertension | 0 | 0 | 43 | 14 | 29 | 4 | 24 | 6 |
| Nausea | 4 | 0 | 43 | 0 | 17 | 4 | 21 | 2 |
| AST level increased | 22 | 4 | 19 | 5 | 13 | 4 | 18 | 4 |
| Headache | 4 | 0 | 33 | 0 | 13 | 0 | 16 | 0 |
| Leukopenia | 4 | 0 | 24 | 14 | 8 | 8 | 12 | 7 |
| Dizziness | 0 | 0 | 19 | 0 | 13 | 0 | 10 | 0 |
| Frequent bowel movements | 0 | 0 | 14 | 0 | 17 | 0 | 10 | 0 |
| Dysgeusia | 9 | 0 | 19 | 0 | 4 | 0 | 10 | 0 |
| ALT level increased | 9 | 4 | 14 | 5 | 8 | 4 | 10 | 4 |
| Dyspnea | 4 | 0 | 14 | 0 | 13 | 0 | 10 | 0 |
| Pyrexia | 13 | 0 | 5 | 0 | 8 | 0 | 9 | 0 |
| Blood alkaline phosphatase level increased | 9 | 0 | 14 | 5 | 4 | 0 | 9 | 2 |
| Febrile neutropenia | 4 | 4 | 5 | 0 | 13 | 8 | 7 | 4 |
| Upper abdominal pain | 0 | 0 | 5 | 0 | 17 | 4 | 7 | 2 |
| Dyspepsia | 4 | 0 | 14 | 0 | 4 | 0 | 7 | 0 |
| Increased appetite | 4 | 0 | 10 | 0 | 8 | 0 | 7 | 0 |
| Vomiting | 0 | 0 | 10 | 0 | 8 | 4 | 6 | 2 |
| Flatulence | 0 | 0 | 14 | 0 | 4 | 0 | 6 | 0 |
| Cough | 9 | 0 | 5 | 0 | 4 | 0 | 6 | 0 |
| Blood bilirubin level increased | 4 | 0 | 5 | 0 | 0 | 0 | 6 | 0 |