Analysis Sets
GIST
The dose-determining set included all patients in the phase I study who met the minimum exposure standard in the first dose period and completed the day 28 follow-up visit or those who stopped treatment due to a DLT. The efficacy analysis set included all patients who received at least one dose of the study drug and had a measurable baseline lesion.The safety population included all Chinese patients (phase I patients and phase II 3L+ patients) with unresectable or metastatic GIST. The efficacy population included patients in two groups: those with a 