Table II.
The number of patients with dose-limiting toxicities (DLT) during the first cycle (N=2 patients with DLT)* and study regimen-related adverse events during any cycle (N=6 patients).
| Adverse Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | DLT Y/N (#, grade) |
|---|---|---|---|---|---|
| Hematological | |||||
| Anemia | 2 | 1 | 1 | 0 | N |
| Neutropenia | 1 | 1 | 1 | 3 | N |
| Febrile neutropenia | 0 | 0 | 1 | 1 | Y (1, Grade 4) |
| Thrombocytopenia | 3 | 0 | 1 | 2 | Y (1, Grade 4) |
| Gastrointestinal | |||||
| Nausea | 3 | 0 | 0 | 0 | N |
| Vomiting | 1 | 0 | 0 | 0 | N |
| Diarrhea | 1 | 1 | 0 | 0 | N |
| Constipation | 1 | 0 | 0 | 0 | N |
| Other | |||||
| Anorexia | 3 | 0 | 0 | 0 | N |
| Cough | 2 | 0 | 0 | 0 | N |
| Dyspnea | 1 | 0 | 0 | 0 | N |
| Fatigue | 2 | 2 | 0 | 0 | N |
| Hyperglycemia | 4 | 0 | 0 | 0 | N |
| Hypoalbuminemia | 2 | 1 | 0 | 0 | N |
| Hypomagnesaemia | 3 | 0 | 0 | 0 | N |
| Hypocalcemia | 1 | 0 | 0 | 0 | N |
| Hyponatremia | 1 | 0 | 0 | 0 | N |
| Insomnia | 1 | 0 | 0 | 0 | N |
| Limb pain | 0 | 2 | 0 | 0 | N |
| QTc prolongation | 0 | 0 | 1 | 0 | N |
| Abnormal liver test | 2 | 0 | 0 | 0 | N |
| Weight loss | 1 | 0 | 0 | 0 | N |
*
DLT: One patient with grade 4 thrombocytopenia and one with grade 4 febrile neutropenia.