Statistical analysis
EVENT
All safety, tolerance, PK, and antitumor data from each dose group were tabulated and summarized according to the statistical analysis plan. The statistical analysis of the study was descriptive. The continuous variables were described as mean ± standard deviation or median (minimum, maximum). For the PK data, geometric mean and geometric mean coefficient of variation were also provided. The categorical variables were described as n (%). PFS was summarized using the Kaplan–Meier method. Percentiles (25%, median, 75%) of the event time distribution were presented along with their two-sided 95% confidence interval (CI). All data processing, summaries, and analyses were performed using SAS 9.4 (SAS Institute, Cary, NC, USA).