Statistical analyses
TRAEs
ADVERSE EVENT
According to the requirements of the Chinese National Medical Products Administration for a post-marketing study, 2000 patients were planned to be enrolled in the study. The intention-to-treat (ITT) population was defined as all enrolled patients. The analyses of demographics and baseline characteristics were based on the ITT population. Efficacy was evaluated in the ITT population, and safety was assessed in those who received at least one dose of apatinib. Adverse events, TRAEs, as well as TRAEs of special interest, were summarized by the incidence rate. Median OS and PFS were estimated using the Kaplan–Meier method. ORR, DCR, OS at 3 and 6 months, and PFS at 3 and 6 months were calculated, and their 95% CIs were estimated according to the Clopper-Pearson method. A study steering committee was established to review the efficacy and safety data. Statistical analysis system version 9.4 was used for all analyses.