Table 2.
Treatment-related adverse events at each level
| Adverse Events / CTCAE Grade | Level 1 | Level 2a | Level 2b | Level 3 | Total | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n = 3 | n = 3 | n = 3 | n = 6 | n = 15 | ||||||||||||||||
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| Neutropenia | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 4 | 2 | 0 | 1 | 9 | 5 |
| Leukopenia | 0 | 0 | 3 | 0 | 0 | 1 | 2 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 3 | 1 | 1 | 4 | 9 | 1 |
| Alopecia | 3 | 0 | NA | NA | 1 | 2 | NA | NA | 0 | 2 | NA | NA | 2 | 4 | NA | NA | 6 | 8 | NA | NA |
| Peripheral sensory neuropathy | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 3 | 0 | 0 | 4 | 7 | 2 | 0 |
| Anemia | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 4 | 0 | 0 | 3 | 8 | 1 | 0 |
| Diarrhea | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 3 | 2 | 0 | 0 | 7 | 4 | 1 | 0 |
| Decreased appetite | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 4 | 1 | 0 | 0 | 8 | 3 | 1 | 0 |
| Nausea | 2 | 0 | 0 | NA | 2 | 0 | 0 | NA | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 8 | 2 | 0 | 0 |
| Stomatitis | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 4 | 0 | 0 | 0 | 8 | 2 | 0 | 0 |
| Fatigue | 1 | 0 | 0 | NA | 0 | 2 | 0 | NA | 1 | 1 | 1 | NA | 1 | 1 | 2 | NA | 3 | 4 | 3 | NA |
| Dysgeusia | 1 | 0 | NA | NA | 3 | 0 | NA | NA | 0 | 1 | NA | NA | 4 | 0 | NA | NA | 8 | 1 | NA | NA |
| Skin hyperpigmentation | 1 | 0 | NA | NA | 1 | 0 | NA | NA | 2 | 0 | NA | NA | 4 | 1 | NA | NA | 8 | 1 | NA | NA |
| Dry skin | 0 | 1 | 0 | NA | 0 | 1 | 0 | NA | 1 | 1 | 0 | NA | 4 | 0 | 0 | NA | 5 | 3 | 0 | NA |
| ALT level increased | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 5 | 0 | 1 | 0 |
| AST level increased | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 5 | 0 | 1 | 0 |
| Myalgia | 1 | 1 | 0 | NA | 1 | 0 | 0 | NA | 2 | 0 | 0 | NA | 1 | 0 | 0 | NA | 5 | 1 | 0 | NA |
| Abdominal pain | 0 | 0 | 0 | NA | 1 | 1 | 0 | NA | 0 | 2 | 0 | NA | 2 | 0 | 0 | NA | 3 | 3 | 0 | NA |
| Peripheral edema | 0 | 0 | 0 | NA | 1 | 1 | 0 | NA | 0 | 0 | 0 | NA | 2 | 2 | 0 | NA | 3 | 3 | 0 | NA |
| Lymphopenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 3 | 3 | 0 |
| Constipation | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 5 | 0 | 0 | 0 |
| Thrombocytopenia | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 5 | 0 | 0 | 0 |
| Watering of eyes increased | 0 | 0 | 0 | NA | 0 | 0 | 0 | NA | 1 | 0 | 0 | NA | 4 | 0 | 0 | NA | 5 | 0 | 0 | NA |
ALT, Alanine aminotransferase; AST, Aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; NA, not applicable