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Planned sample size:
N = 702 patients (2:1 randomization)
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Co-primary endpoints:
PFS and OS
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PFS assumption:
study has ≥95% power to detect an HR of 0.67 with 458 events, using a
2-sided 0.025 level log rank test
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Interim analysis (IA) of PFS was planned after ~367 (80%) of events
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Actual IA conducted after 371 events. Results from this planned IA of PFS are reported
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OS assumption:
study has ≥85% power to detect an HR of 0.73 with 491 deaths, using a
2-sided 0.025 level log rank test
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Study remains blinded to OS at this time. Final analysis of OS planned after target number of
deaths has been reached
HR, hazard ratio; ITT, intention-to-treat; OS, overall survival; PFS, progression-free survival