TABLE 2.
Summary of DLTs by Dose Level—DLT-Evaluable Cohort
| Variable | Unesbulin Dose Level | ||
|---|---|---|---|
| 200 mg | 300 mg | 400 mg | |
| Subjects, No. | 4 | 19 | 4 |
| Subjects with DLTs, No. (%) | 1 (25) | 3 (15.8) | 3 (75) |
| DLT event | Thrombocytopenia (grade 3) | Thrombocytopenia (grade 3) and neutropenia (grade 4) | Neutropenia (grade 4) and thrombocytopenia (grade 3) |
| Neutropenic fever and sepsis (grade 3) | Neutropenia (grade 4) | ||
| Gastric perforation (grade 3) | Thrombocytopenia (grade 4) and clinically significant bleeding | ||
NOTE. A DLT event was assessed as per DLT definitions in version 5.0 of the protocol. The subject with GI perforation had a history of GI perforation and was receiving ibuprofen and diclofenac.
Abbreviation: DLT, dose-limiting toxicity.