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b All treatment-related grade 3/4 toxicities occurring per cohort
| Cohort | Gemcitabine dose, mg/m2 | Patients, n | Hematological AEs, n |
Gastrointestinal and hepatic AEs, n |
Other toxicity AEs, n |
DLTs, n | SAEs, n | |||
|---|---|---|---|---|---|---|---|---|---|---|
| G3 | G4 | G3 | G4 | G3 | G4 | |||||
| 1 | 600 | 3 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 2 | 800 | 3 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 4 |
| 3 | 1,000 | 3 | 3 | 1 | 4 | 2 | 3 | 2 | 1 | 10 |
| 3 exp. | 1,000 | 3 | 8 | 1 | 2 | 0 | 2 | 0 | 1 | 2 |
| Total | 12 | 2 | 16 | |||||||
AE, adverse event; DLT, dose limiting toxicity; SAE, serious adverse event.
