Table 2.
Grade 3 and 4 AEs in three or more patients at least possibly related to study drug, all cycles
AE | 80–640 mg/m2/day (n=8) | 905 mg/m2/day (n=6) | 1280 mg/m2/day (n=8) | 1810 mg/m2/day (n=3) | Expanded Cohort (n=4) | |||||
---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||
Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
Hypertriglyceridemia | 1 | 0 | 0 | 4 | 0 | 2 | 0 | 2 | 0 | 0 |
Non-Hematologic, any | 2 | 0 | 1 | 4 | 3 | 4 | 0 | 3 | 1 | 3 |
Hemoglobin reduced | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
Leukocytes reduced | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Lymphocytes reduced | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
Neutrophils reduced | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
Platelets reduced | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 1 | 0 | 3 |
Hematologic, any | 0 | 0 | 1 | 1 | 3 | 3 | 0 | 1 | 1 | 3 |