Table 2.
Hematological and non-hematological toxicities grade 2 and higher (cycle 1 and all cycles) at least possibly related to therapy: phase I part of study
| AE_NAME | DL 30 mcg/m2 (n = 5) |
DL 45 mcg/m2 (n = 3) |
DL 60 mcg/m2 (n = 6) |
DL 80 mcg/m2 (n = 4) |
|---|---|---|---|---|
| Cycle 1 | ||||
| Death | 1 | 0 | 0 | 0 |
| Dehydration grade 3/4 | 1 | 0 | 0 | 1 |
| Diarrhea grade 2/3 | 0 | 0 | 2 | 1 |
| Fatigue grade 2 | 0 | 0 | 3 | 1 |
| Fatigue grade 3 | 0 | 0 | 0 | 1 |
| Hypocalcemia grade 2/3 | 1 | 0 | 2 | 0 |
| Hyponatremia grade 3 | 1 | 0 | 1 | 0 |
| Hypophosphatemia grade 3 | 0 | 0 | 1 | 0 |
| Hypotension grade 2/3 | 0 | 1 | 1 | 0 |
| Hypotension grade 4 | 1 | 0 | 0 | 0 |
| Muscle weakness grade 3 | 0 | 0 | 0 | 1 |
| Neutropenia grade 2 | 2 | 2 | 0 | 0 |
| Neutropenia grade 3 | 1 | 0 | 1 | 0 |
| Neutropenia grade 4 | 1 | 1 | 1 | 2 |
| Febrile neutropenia | 1 | 0 | 0 | 0 |
| Thrombosis grade 3 | 0 | 0 | 1 | 2 |
| All cycles | ||||
| Dehydration grade 2/3 | 1 | 0 | 1 | 2 |
| Dehydration grade 4 | 1 | 0 | 0 | 0 |
| Diarrhea grade 2/3 | 0 | 0 | 2 | 1 |
| Fatigue grade 2/3 | 0 | 1 | 5 | 2 |
| Hypocalcemia grade 2/3 | 1 | 0 | 2 | 0 |
| Hyponatremia grade 3 | 1 | 0 | 1 | 0 |
| Hypophosphatemia grade 2 | 0 | 1 | 1 | 0 |
| Hypophosphatemia grade 3 | 0 | 0 | 1 | 0 |
| Hypotension grade 3 | 0 | 0 | 2 | 0 |
| Infection grade 3 | 0 | 0 | 1 | 0 |
| Infection grade 5 | 1 | 0 | 0 | 0 |
| Nausea grade 3 | 0 | 0 | 0 | 1 |
| Neutropenia grade 2 | 2 | 2 | 1 | 0 |
| Neutropenia grade 3 | 2 | 0 | 1 | 0 |
| Neutropenia grade 4 | 1 | 1 | 1 | 2 |
| Febrile neutropenia | 2 | 1 | 0 | 0 |
| Neuropathy grade 2 | 1 | 0 | 1 | 0 |
| Pain grade 2 | 1 | 0 | 0 | 1 |
| Pulmonary embolus grade 4 | 1 | 0 | 0 | 0 |
| Thrombosis grade 3 | 0 | 0 | 0 | 1 |
| Vomiting grade 3 | 0 | 0 | 1 | 0 |