{"analyses":[{"ciLowerLimit":"0.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.75","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":"0.62","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":"6.9","upperLimit":"8.3","value":"7.3"},{"groupId":"OG001","lowerLimit":"4.9","upperLimit":"6.0","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"323"}],"units":"Participants"}],"description":"Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.\n\nProgressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions.\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. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.","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":"ITT Analysis Set","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":"Progression-Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}