Table 2.
Maximum toxicity per patient during the dose limiting toxicity evaluation period (n = 6)
| Adverse event | NCI-CTC grade | |
|---|---|---|
| All grades, n (%) | ≥ Grade 3, n (%) | |
| Hematologic | ||
| Leukopenia | 0 (0) | 0 (0) |
| Neutropenia | 0 (0) | 0 (0) |
| Thrombocytopenia | 0 (0) | 0 (0) |
| AST increased | 1 (17) | 0 (0) |
| ALT increased | 1 (17) | 1 (17) |
| Hypoalbuminemia | 2 (33) | 0 (0) |
| Hypokalemia | 2 (33) | 0 (0) |
| Hyponatremia | 1 (17) | 1 (17) |
| Hypomagnesemia | 2 (33) | 0 (0) |
| Non-hematologic | ||
| Alopecia | 2 (33) | – |
| Anorexia | 3 (50) | 0 (0) |
| Conjunctivitis | 1 (17) | 0 (0) |
| Constipation | 1 (17) | 0 (0) |
| Diarrhea | 4 (67) | 0 (0) |
| Dry skin | 2 (33) | 0 (0) |
| Fatigue | 1 (17) | 0 (0) |
| Febrile neutropenia | 0 (0) | 0 (0) |
| Infusion-related reaction | 1 (17) | 0 (0) |
| Malaise | 3 (50) | – |
| Nausea | 3 (50) | 0 (0) |
| Palpitations | 1 (17) | 0 (0) |
| Peripheral sensory neuropathy | 3 (50) | 0 (0) |
| Pruritus | 1 (17) | 0 (0) |
| Rash acneiform | 3 (50) | 0 (0) |
| Stomatitis | 2 (33) | 0 (0) |
| Vomiting | 1 (17) | 0 (0) |
| Weight loss | 1 (17) | 0 (0) |
NCI-CTC National Cancer Institute Common Toxicity Criteria, AST aspartate transaminase, ALT, alanine transaminase