Table 2.
Nonhematologic Toxicity
| Select Adverse Events | Cohorts 1-4 at Dose Level 3-24 units/m2 (n = 8) |
Cohorts 5-8 at Dose Level 32-76 units/m2 (n = 14) |
Cohorts 9-10 at Dose Level 101-134 units/m2 (n = 26) |
All Cohorts at Dose Level 3-134 units/m2 (N = 48) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 3 |
Grade 4 |
Grade 3 |
Grade 4 |
Grade 3 |
Grade 4 |
Grade 3 |
Grade 4 |
|||||||||
| No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
| Mucositis | — | — | — | — | 1 | 3.8 | — | 1 | 2.1 | — | ||||||
| Diarrhea | — | — | — | — | — | — | — | — | ||||||||
| Nausea | — | — | — | — | — | — | — | — | ||||||||
| Vomiting | — | — | — | — | — | — | 1 | 2.1 | — | |||||||
| Skin rash | — | — | 1 | 7.1 | — | 2 | 7.7 | — | 3 | 11.5 | — | |||||
| Alopecia | — | — | — | — | — | — | — | — | ||||||||
| Cardiac (LVEF) | — | — | — | — | 2 | 7.7 | — | 2 | 4.2 | — | ||||||
| Creatinine | — | — | — | — | — | — | — | — | ||||||||
| Bilirubin | — | — | — | — | 1 | 3.8 | — | 1 | 2.1 | — | ||||||
| AST/ALT | — | — | — | — | 2 | 7.7 | — | 2 | 4.2 | — | ||||||
Abbreviation: LVEF, left ventricular ejection fraction.