Statistical analysis
intracranial TTP
Based on the phase II OO 12-01 study,The Full Analysis Set (FAS) included all enrolled patients who had received at least one dose of unecritinib except for the patients enrolled into the exploratory study cohort, and the Per Protocol Set (PPS) included all enrolled patients who had received at least one cycle of treatment, with at least one radiological evaluation, good compliance, and no major study protocol violations. The pharmacokinetics concentration set included all enrolled patients who had received at least one dose of unecritinib and had one post-treatment measurement of plasma concentration of unecritinib. The pharmacokinetics parameter set includes all enrolled patients who had received at least one dose of unecritinib and had at least one valid pharmacokinetic parameter data. The safety set included all enrolled patients who had received at least one dose of unecritinib. No imputation was done for missing data. We estimated 95% CIs using the conventional Wald method for ORR and the Clopper-Pearson method for DCR and intracranial ORR. ORR and its 95% CI were presented graphically using forest plots. Kaplan–Meier methods were used to determine medians and 95% CIs for DOR, PFS, intracranial DOR, intracranial TTP and intracranial PFS. AEs were mainly analyzed using descriptive statistics.Statistical analyses were undertaken using the SAS software package, version 9.4 M5 (SAS Institute Inc., Cary, NC). All tests were two-tailed with a level of significance set at 