{"analyses":[{"ciLowerLimit":"6.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"19.4","groupIds":["OG000","OG001"],"nonInferiorityComment":"Treatment A over Treatment B","nonInferiorityType":"SUPERIORITY","paramType":"Odds Ratio (OR)","paramValue":"12.7","statisticalMethod":"Mantel Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"32.9","upperLimit":"43.2","value":"38.0"},{"groupId":"OG001","lowerLimit":"20.7","upperLimit":"30.0","value":"25.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"358"}],"units":"Participants"}],"description":"ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab + Ipilimumab + Chemotherapy","id":"OG000","title":"Treatment A"},{"description":"Chemotherapy only","id":"OG001","title":"Treatment B"}],"paramType":"NUMBER","populationDescription":"All Randomized Participants, Global Population","reportingStatus":"POSTED","timeFrame":"From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)","title":"Objective Response Rate (ORR) by BICR","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}