Statistical Analyses
immune-mediated adverse
CPS
Efficacy data were reported for the subgroup of Japanese patients from KEYNOTE-059 cohort 1 and the subgroup of Japanese patients with CPS ≥ 1 and CPS ≥ 10 from both KEYNOTE-061 and KEYNOTE-062 who had received ≥ 1 dose of study drug. Safety data were reported for all Japanese patients from each study. Patients could have had more than 1 immune-mediated adverse events (imAEs). Results were analyzed for each of the trials separately (i.e., results were not pooled across trials). The primary efficacy analyses were performed in the CPS ≥ 1 populations of the KEYNOTE-059 (cohort 1) and in the CPS ≥ 1 and CPS ≥ 10 populations of the KEYNOTE-061 and KEYNOTE-062 studies.The database cutoff dates for this analysis were August 8, 2018 (KEYNOTE-059; NCT02335411); October 26, 2017 (KEYNOTE-061; NCT02370498); and March 26, 2019 (KEYNOTE-062; NCT02494583).Additional details can be found in Online Resource 1.