Table 3.
Drug-related adverse events, worst grade per patient per cycle 1.
| Selected Toxicities | Dose level 1 (n = 7) | Dose level 2 (n = 4) | Dose level 3a (n = 22) | Total (n = 33), % | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||
| G1 | G2 | G3/4 | G1 | G2 | G3/4 | G1 | G2 | G3/4 | ||
| Hematologic | ||||||||||
| Neutropenia | 1 | 3 | ||||||||
| Anemia | 3 | 9 | ||||||||
| Thrombocytopenia | 1 | 3 | ||||||||
| Non-Hematologic | ||||||||||
| Nausea | 2 | 10 | 1 | 1 | 42 | |||||
| Vomiting | 1 | 1 | 5 | 5 | 36 | |||||
| Diarrhea | 3 | 3 | 7 | 5 | 1 | 58 | ||||
| Acneiform Rash | 5 | 2 | 1 | 3 | 12 | 8 | 1* | 97 | ||
| Dry Skin | 2 | 1 | 1 | 2 | 1 | 21 | ||||
| Headache | 1 | 1 | 2 | 12 | ||||||
| Fever | 3 | 1 | 1 | 15 | ||||||
| Fatigue | 1 | 1 | 2 | 9 | 4 | 1 | 55 | |||
| Mucositis | 1 | 2 | 9 | |||||||
| Blurry Vision | 1 | 3 | 12 | |||||||
| Hypokalemia | 2 | 6 | ||||||||
| Hypophosphatemia | 1 | 3 | ||||||||
| Hyponatremia | 1 | 2 | 9 | |||||||
| Hypomagnesemia | 1* | 4 | 15 | |||||||
| Transaminitis | 2 | 3 | 3 | 24 | ||||||
AEs at least possibly related to drug were included.
a
Includes patients at dose level 3 and the dose expansion cohort
*
DLT