Table 3.
Grade 3/4 drug-related adverse events
| Dose level 1 0.3/800 mg/m2 trabectedin/gemcitabine (n = 6) | Dose level 2 0.4/800 mg/m2 trabectedin/gemcitabine (n = 3) | Dose level 3 0.4/1000 mg/m2 trabectedin/gemcitabine (n = 6) | Total [N = 15 (%)] | |
|---|---|---|---|---|
| Total with grade 3/4 AE | 3 | 2 | 3 | 8 (53) |
| ALT increased | 1 | 2 | 2 | 5 (33) |
| Vomiting | 2 | 1 | 1 | 4 (27) |
| Neutropenia | 1 | 2 | 1 | 4 (27) |
| AST increased | 1 | 1 | 1 | 3 (20) |
| Weight decreased | 1 | 0 | 0 | 1 (7) |
| Cardiac failure | 1 | 0 | 0 | 1 (7) |
| Acute prerenal failure | 1 | 0 | 0 | 1 (7) |
| Leukopenia | 0 | 0 | 1 | 1 (7) |
| Thrombocytopenia | 0 | 0 | 1 | 1 (7) |
AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase
Note: AEs reported at any time from first treatment dose to within 30 days of last treatment dose are included. Incidence is based on the number of patients. Drug-related means possible, probable, or very likely. Toxicity grade: NCI Common Toxicity Criteria, version 2.0