Table 2.
Treatment-related adverse events across all patients and dose level cohorts
| Overall, n (%) | G1/2, n (%) | G3, n (%) | G4, n (%) | |
|---|---|---|---|---|
| Hematological toxicity | ||||
| Anemia | 9 (75) | 5 (42) | 4 (33) | 0 |
| Thrombopenia | 9 (75) | 7 (58) | 2 (17) | 0 |
| Lymphopenia | 7 (58) | 4 (33) | 2 (17) | 1 (8) |
| Leukopenia | 7 (58) | 3 (25) | 3 (25) | 1 (8) |
| Neutropenia | 6 (50) | 2 (17) | 4 (33) | 0 |
| Gastrointestinal and hepatic toxicity | ||||
| Nausea | 6 (50) | 50 | 0 | 0 |
| Anorexia | 5 (42) | 5 (42) | 0 | 0 |
| AST increase | 4 (33) | 2 (17) | 2 (17) | 0 |
| AP increase | 3 (25) | 1 (8) | 2 (17) | 0 |
| ALT increase | 2 (17) | 1 (8) | 1 (8) | 0 |
| GGT increase | 2 (17) | 0 | 1 (8) | 1 (8) |
| BLT infection | 2 (17) | 1 (8) | 0 | 1 (8)* |
| Constipation | 2 (17) | 2 (17) | 0 | 0 |
| Diarrhea | 2 (17) | 2 (17) | 0 | 0 |
| Gastritis | 2 (17) | 2 (17) | 0 | 0 |
| Duodenal ulceration | 1 (8) | 1 (8) | 0 | 0 |
| Others | ||||
| Fatigue | 8 (67) | 4 (33) | 4 (33) | 0 |
| Infections other than BLT | 4 (33) | 1 (8) | 2 (17) | 1 (8)* |
| Hyponatremia | 3 (25) | 3 (25) | 0 | 0 |
| Tinnitus | 2 (17) | 2 (17) | 0 | 0 |
| Paresthesia | 2 (17) | 2 (17) | 0 | 0 |
| Fever | 2 (17) | 2 (17) | 0 | 0 |
AP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BLT, biliary tract; GGT, γ-glutamyltransferase. * Dose limiting toxicity.