{"analyses":[{"ciLowerLimit":"0.70","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.92","estimateComment":"The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0011","pValueComment":"The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.","paramType":"Hazard Ratio (HR)","paramValue":"0.80","statisticalComment":"One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\\<5% vs ≥5%), and presence of peritoneal metastasis.","statisticalMethod":"One-Sided Log-Rank Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.6","upperLimit":"16.5","value":"15.0"},{"groupId":"OG001","lowerLimit":"12.1","upperLimit":"14.1","value":"12.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"501"},{"groupId":"OG001","value":"496"}],"units":"Participants"}],"description":"Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.","id":"OG000","title":"Tislelizumab + Chemotherapy"},{"description":"Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"The Intent-to-Treat (ITT) Analysis Set included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.","title":"Overall Survival in the Intent-to-Treat (ITT) Analysis Set","type":"PRIMARY","unitOfMeasure":"months"}