{"analyses":[{"ciLowerLimit":"0.54","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.80","estimateComment":"Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Stratified Hazard Ratio","paramValue":"0.66","statisticalComment":"One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice","statisticalMethod":"Stratified Log-rank Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.8","upperLimit":"20.1","value":"17.2"},{"groupId":"OG001","lowerLimit":"9.3","upperLimit":"12.1","value":"10.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"323"}],"units":"Participants"}],"description":"Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.\n\nPrimary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.","id":"OG000","title":"Tislelizumab + Chemotherapy"},{"description":"Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"The ITT analysis set included all randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}