Table 2.
Incidence of hematological and non-hematologic toxicity.
| Adverse event Grade of adverse event |
Dose Level | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 (n = 3)
|
2 (n = 8)
|
|||||||
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| Blood/Bone Marrow | ||||||||
| Hemoglobin | 2 | 1 | 7 | 1 | ||||
| Neutrophils | 1 | 1 | 1^ | 1 | 2 | 3† | ||
| Platelets | 1 | 1 | 1 | 1 | 2#† | |||
| Constitutional Symptoms | ||||||||
| Fatigue | 1 | 4 | 3 | |||||
| Fever | 1 | 2 | 1 | |||||
| Gastrointestinal | ||||||||
| Constipation | 4 | 1 | ||||||
| Diarrhea | 1 | 1 | 3 | 4 | ||||
| Nausea/vomiting | 2* | 6 | 2 | |||||
| Infection/Febrile Neutropenia | ||||||||
| Febrile neutropenia | 1^ | |||||||
| Infection with Gr. 3/4 neutrophils – urinary tract | 1 | 1† | ||||||
| Metabolic/Laboratory | ||||||||
| Albumin, serum-low | 1 | 2 | 3 | |||||
| ALT, SGPT | 1 | 1 | 1 | |||||
| AST, SGOT | 1 | 1 | 1 | |||||
| Calcium, serum-low | 1 | 2 | 2 | 2 | ||||
| GGT | 1 | 1# | ||||||
| Magnesium, serum-low | 1 | 3 | ||||||
| Potassium, serum-low | 1 | 2 | 1 | 1† | ||||
| Sodium, serum-low | 2 | 1 | 3 | |||||
| Neurology | ||||||||
| Neuropathy - sensory | 1 | 4 | ||||||
| Pain | ||||||||
| Abdomen, NOS | 2#† | |||||||
Dose level 1: DLTs - *one patient with grade 3 nausea/vomiting and ^one patient with grade 3 febrile neutropenia.
Dose level 2: DLT- #one patient with grade 4 thrombocytopenia, grade 3 abdominal pain, and grade 3 GGT.
No DLT- †one patient with grade 4 thrombocytopenia, grade 4 hypokalemia, grade 3 infection (urinary tract) with grade 4 neutrophils, and grade 3 abdominal pain (see text).