{"analyses":[{"ciLowerLimit":"-22.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-7.4","groupDescription":"ORR in participants of the pembro arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \\& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\\<10 vs. CPS≥10) at baseline.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValueComment":"No formal hypothesis testing was performed.","paramType":"Difference in Percentage","paramValue":"-14.8"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"25.2","upperLimit":"35.8","value":"30.3"},{"groupId":"OG002","lowerLimit":"39.6","upperLimit":"50.2","value":"44.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"307"},{"groupId":"OG002","value":"352"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro combo arm and chemo arm and is presented earlier in the record.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle.","id":"OG000","title":"Pembrolizumab + ST Chemotherapy (Pembro Combo)"},{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.","id":"OG001","title":"Pembrolizumab (Pembro)"},{"description":"Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle.","id":"OG002","title":"ST Chemotherapy (Chemo)"}],"paramType":"NUMBER","populationDescription":"All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 42 months","title":"Pembro vs Chemo: ORR Using RECIST 1.1 as Assessed by BICR","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}