Table II.
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.