Endpoints and assessments
tumor, immune-mediated adverse, death, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, SECONDARY, CANCER
The independent co-primary endpoint of OS in patients with tumor PD-L1 expression ≥ 1% and secondary endpoints were previously reported [Safety and tolerability, including treatment-related adverse events (TRAEs) and immune-mediated adverse events (IMAEs) were assessed in all treated Japanese patients. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Additional details on AEs are included in the supplementary methods (online only).Post hoc analyses in Japanese patients included efficacy outcomes (PFS, ORR, and DOR) evaluated in the combined PD-L1 ≥ 1% and < 1% population of patients alive at 5 years, efficacy outcomes (OS, PFS, ORR, and DOR) in the combined PD-L1 ≥ 1% and < 1% population of patients who discontinued study treatment due to TRAEs, and treatment-free interval (TFI; the time from last study dose to start of subsequent systemic therapy or death, whichever occurred first) measured in patients who discontinued study therapy (for any reason), in 5-year survivors, and in patients who discontinued study treatment due to TRAEs.