Table 3.
Number of patients experiencing selected adverse events by dose level
| Dose level 1 (n = 18) |
Dose level 2 (n = 3) |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| AE grade |
AE grade |
||||||||
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | |
| Non-hematologic AE | |||||||||
| Elevated alkaline phosphatase | 3 | 2 | |||||||
| Allergic reaction | 1 | ||||||||
| Elevated ALT | 4 | 1 | |||||||
| Anorexia | 1 | 1 | |||||||
| Elevated AST | 7 | 1 | 1 | ||||||
| Dehydration | 1 | ||||||||
| Diarrhea | 2 | 7 | 3 | 1 | 1 | ||||
| Dry skin | 3 | ||||||||
| Dyspnea | 3 | 1 | |||||||
| Edema | 5 | 2 | 1 | ||||||
| Fatigue | 11 | 3 | 2 | ||||||
| Hand–foot skin reaction | 1 | 1 | 1 | ||||||
| Headache | 3 | 1 | |||||||
| Hypercholesterolemia | 4 | ||||||||
| Hyperglycemia | 9 | 4 | 1 | 1 | 1 | ||||
| Hypertension | 1 | 4 | 1 | 1 | |||||
| Hypertriglyceridemia | 5 | 1 | 1 | ||||||
| Hypoalbuminemia | 1 | 1 | |||||||
| Hypocalcemia | 9 | 1 | 2 | 3 | |||||
| Hypokalemia | 3 | 1 | |||||||
| Hypomagnesemia | 6 | 1 | |||||||
| Hyponatremia | 3 | 1 | |||||||
| Hypophosphatemia | 3 | 3 | 3 | 1 | 1 | ||||
| Infection | 2 | ||||||||
| Stomatitis | 7 | 1 | |||||||
| Nausea | 9 | 1 | 1 | 1 | |||||
| Neuropathy | 3 | ||||||||
| Mouth pain | 3 | 1 | |||||||
| Bowel perforation | 1 | ||||||||
| Pneumonitis | 1 | ||||||||
| Pruritus | 5 | ||||||||
| Rash | 8 | 5 | 2 | 1 | 1 | ||||
| Voice changes | 2 | ||||||||
| Vomiting | 6 | 1 | 2 | ||||||
| Weight loss | 3 | ||||||||
| Hematologic AE | |||||||||
| Anemia | 13 | 2 | 2 | 1 | |||||
| Leukopenia | 6 | 4 | 1 | 2 | 1 | ||||
| Lymphopenia | 2 | 1 | |||||||
| Neutropenia | 4 | 5 | 1 | 2 | |||||
| Thrombocytopenia | 11 | 3 | 2 | 1 | 1 | ||||