{"analyses":[{"ciLowerLimit":"6.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"16.0","estimateComment":"Difference in % vs Placebo","groupDescription":"Difference in % vs Placebo","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"Based on Miettinen \\& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\\< 200 vs. \\>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.","pValue":"0.00004","paramType":"Percent Difference","paramValue":"11.4","statisticalComment":"H0: difference in % =0 versus H1: difference in % \\> 0.","statisticalMethod":"One-sided p-value for testing"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.1","upperLimit":"17.0","value":"12.7"},{"groupId":"OG001","lowerLimit":"0.2","upperLimit":"4.6","value":"1.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"153"}],"units":"Participants"}],"description":"ORR is the percentage of participants who achieve complete response (CR) or partial response (PR) with confirmation per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.","id":"OG000","title":"Pembrolizumab + BSC"},{"description":"Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.","id":"OG001","title":"Placebo + BSC"}],"paramType":"NUMBER","populationDescription":"All randomized participants based on the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 4 years","title":"Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}