Table 2.

Dose-limiting toxicity analysis.

Dose levelDLTDLT rate (%)Description
ARM 1 (DD)D 0 200 mg1/616.7G3 diarrhea
D I 250 mg3/1225G4 neutropenia; G3 ALT elevation; G3 fatigue
ARM 2 (MN)D 0 200 mg1/616.7Dose reduction due to G3 neutropenia
D I 250 mg5/1241.7G3 ALT elevation; G3 fatigue; Dose reduction due to G3 neutropenia
D II 300 mg1/250G4 neutropenia; G4 ALT elevation; G4 AST elevation
  • Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; D, dose level; DD, dose-dense; DLT, dose-limiting toxicity; G, grade; MN, metronomic.