Statistical analysis
EVENTS
Approximately 380 patients with HRR gene alterations were to be enrolled. To maintain overall type I error at or below a one-sided alpha level of 0.025, alpha was split equally between the all-comers cohort and HRR-deficient population.For the primary comparison in the HRR-deficient population, 224 PFS events based on a Lan DeMets α-spending function would provide 85% power to detect an HR of 0.64 using a one-sided stratified log-rank test at a significance level of 0.0125. A prespecified interim analysis of PFS was planned after approximately 70% of the expected events (157 events). The HRR-deficient cohort would be stopped if the efficacy boundary was crossed and an interim efficacy analysis of overall survival would be performed. As the efficacy boundary (Time-to-event endpoints were compared between treatment groups using a stratified log-rank test unless otherwise stated. HRs and associated 95% two-sided CIs were estimated by a Cox proportional hazards model. Median time-to-event endpoints were estimated by the Kaplan–Meier method, and 95% CIs based on the Brookmeyer–Crowley method. For subgroup analysis of rPFS (except by Oracle Clinical Remote Data Capture was used for data collection, and SAS version 9.4 was used for data analysis.