Statistical analyses
SECONDARY
Efficacy analyses were based on the intention-to-treat population, including all patients who underwent randomization. Survival functions were estimated utilizing Kaplan–Meier curves. The stratified Cox proportional hazards model was used to estimate hazard ratio (HRs) and confidence intervals (CIs), and a comparison of survival between treatment groups was performed using the stratified log-rank test. Safety was assessed in the population of patients who received at least one dose of olaparib or placebo [Analysis of the subset of patients from Japan was performed using the global OlympiA first pre-specified interim analysis DCO date of March 27, 2020. Results for primary and key secondary endpoints of IDFS and DDFS, respectively, are presented for the subset of patients from Japan using this data. Following the event-driven pre-specified second interim analysis of OS for the global OlympiA population at DCO on July 12, 2021, the results of OS for the subset of patients from Japan are also presented here, as well as 4-year data for the primary and key secondary endpoints. Safety data are presented using data from the pre-specified second interim analysis. All data from the subset of patients from Japan is descriptive. The study was not powered to detect treatment differences in the subset of patients from Japan at either DCO.