Table 3.
Treatment-related adverse events.
| Adverse event | Grade 1/grade 2 | Total # pts (%) | Grade 3/grade 4 | Total # pts (%) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 (n = 3) | Cohort 2 (n = 4) | Cohort 3 (n = 3) | Phase II (n = 9) | Cohort 1 (n = 3) | Cohort 2 (n = 4) | Cohort 3 (n = 3) | Phase II (n = 9) | |||
| Diarrhea | 1 | 2 | 1 | 7 | 11 (57.9%) | 1 | 1 | 0 | 0 | 2 (10.5%) |
| Mucositis oral | 0 | 1 | 3 | 6 | 10 (52.6%) | 0 | 0 | 2 | 1 | 3 (15.8%) |
| Fatigue | 2 | 1 | 1 | 3 | 7 (36.8%) | 0 | 0 | 0 | 2 | 2 (10.5%) |
| Nausea | 0 | 1 | 0 | 5 | 6 (31.6%) | 0 | 0 | 0 | 0 | 0 |
| AST increased | 0 | 0 | 3 | 2 | 5 (26.3%) | 0 | 0 | 0 | 0 | 0 |
| Edema limbs | 0 | 2 | 2 | 1 | 5 (26.3%) | 0 | 0 | 0 | 0 | 0 |
| Hyperglycemia | 0 | 0 | 2 | 3 | 5 (26.3%) | 0 | 0 | 1 | 0 | 1 (5.3%) |
| Lipid abnormality | 0 | 1 | 1 | 2 | 4 (21.1%) | 0 | 0 | 0 | 0 | 0 |
| ALT increased | 0 | 0 | 2 | 2 | 4 (21.1%) | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain | 0 | 1 | 1 | 1 | 3 (15.8%) | 0 | 0 | 0 | 0 | 0 |
| Rash acneiform | 1 | 1 | 1 | 0 | 3 (15.8%) | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 0 | 3 | 3 (15.8%) | 0 | 0 | 0 | 0 | 0 |
| Blood bilirubin increased | 0 | 0 | 1 | 1 | 2 (10.5%) | 0 | 0 | 0 | 0 | 0 |
| Dehydration | 1 | 0 | 1 | 0 | 2 (10.5%) | 0 | 0 | 0 | 1 | 1 (5.3%) |
| Fever | 0 | 0 | 0 | 2 | 2 (10.5%) | 0 | 0 | 0 | 1 | 1 (5.3%) |
| Headache | 1 | 0 | 0 | 1 | 2 (10.5%) | 0 | 0 | 0 | 0 | 0 |
| Hoarseness | 1 | 0 | 1 | 0 | 2 (10.5%) | 0 | 0 | 0 | 0 | 0 |
| Hypokalemia | 0 | 0 | 2 | 0 | 2 (10.5%) | 0 | 0 | 1 | 1 | 2 (10.5%) |
| Dermatologic disorders | 0 | 1 | 1 | 0 | 2 (10.5%) | 0 | 0 | 0 | 0 | 0 |
| Weight loss | 0 | 0 | 0 | 2 | 2 (10.5%) | 0 | 0 | 0 | 0 | 0 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase.