P3 / PFS at 2-sided with a 0.05 level of significance. ORR then OS were tested after, hirearchically at a level of 0.05, if PFS was significant. Control of the type I error rate by employing a fixed-sequence testing procedure at 0.05 / An interim analysis for OS at the time of the unblinding PFS (if PFS and ORR are significant)
the overall survival was not significantly improved in the talazoprib group compared to chemotherapy group