{"analyses":[{"ciLowerLimit":"1.73","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.27","estimateComment":"Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"2.38","statisticalComment":"Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"58.0","upperLimit":"68.7","value":"63.5"},{"groupId":"OG001","lowerLimit":"37.0","upperLimit":"48.0","value":"42.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"323"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen.\n\nCR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm.\n\nPR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nTesting for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022).","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":"NUMBER","populationDescription":"ITT Analysis Set","reportingStatus":"POSTED","timeFrame":"Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}