Table 4.
Toxicity in feasibility phase for 4 cycles (N=25 patients).
| Adverse event | |||||
|---|---|---|---|---|---|
| Grade of adverse event | 0 | 1 | 2 | 3 | 4 |
| Allergy | 22 | 3 | 0 | 0 | 0 |
| Auditory | 20 | 1 | 4 | 0 | 0 |
| Blood/bone marrow | |||||
| Hemoglobin | 3 | 10 | 11 | 1 | 0 |
| Neutrophils | 2 | 1 | 4 | 5 | 13* |
| Platelets | 8 | 15 | 1 | 0 | 1# |
| Cardiac | 21 | 3 | 1 | 0 | 0 |
| Coagulation | 22 | 2 | 0 | 1a | 0 |
| Constitutional | 7 | 7 | 10 | 1 | 0 |
| Dermatologic | 3 | 5 | 17 | 0 | 0 |
| Endocrine | 21 | 3 | 1 | 0 | 0 |
| Gastrointestinal | 4 | 10 | 9 | 2 | 0 |
| Genitourinary | 23 | 2 | 0 | 0 | 0 |
| Hemorrhage | 22 | 3 | 0 | 0 | 0 |
| Hepatic | 23 | 1 | 0 | 1$ | 0 |
| Infection | 14 | 1 | 6 | 4^,& | 0 |
| Metabolic | 8 | 9 | 7 | 1 | 0 |
| Musculoskeletal | 22 | 2 | 1 | 0 | 0 |
| Neurologic | 12 | 10 | 3 | 0 | 0 |
| Ocular | 21 | 3 | 1 | 0 | 0 |
| Pain | 10 | 7 | 8 | 0 | 0 |
| Pulmonary | 14 | 7 | 4 | 0 | 0 |
| Sexual/reproductive | 23 | 2 | 0 | 0 | 0 |
DLTs include 1 patient with >2 week delay to recover ANC, *1 with grade 4 thrombocytopenia, #1 with grade 3 LFT abnormalities, $3 with neutropenic fevers and ^one with pneumonia &.
a
Thrombosis related to malignancy.