{"analyses":[{"ciLowerLimit":"0.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.94","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 and presence of peritoneal metastasis as strata.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0056","pValueComment":"The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.","paramType":"Hazard Ratio (HR)","paramValue":"0.74","statisticalComment":"One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).","statisticalMethod":"One-sided Log Rank Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.9","upperLimit":"21.3","value":"17.2"},{"groupId":"OG001","lowerLimit":"12.0","upperLimit":"14.4","value":"12.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"272"}],"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 PD-L1-Positive Analysis Set included all randomized participants whose tumors were PD-L1 positive (defined as PD-L1 TAP score ≥ 5%)","reportingStatus":"POSTED","timeFrame":"From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months.","title":"Overall Survival in PD-L1 Positive Participants","type":"PRIMARY","unitOfMeasure":"months"}