{"analyses":[{"ciLowerLimit":"-35.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-21.6","groupDescription":"DCR in participants of the pembro arm was compared to DCR in participants of the chemo arm 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":"OTHER","pValueComment":"No formal hypothesis testing was performed.","paramType":"Difference in Percentage","paramValue":"-28.9"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"41.5","upperLimit":"53.0","value":"47.2"},{"groupId":"OG002","lowerLimit":"71.0","upperLimit":"80.2","value":"75.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"307"},{"groupId":"OG002","value":"352"}],"units":"Participants"}],"description":"DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD \\[at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD\\]). Per protocol, DCR 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 a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro arm and chemo arm. Per protocol, DCR 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: DCR Using RECIST 1.1 as Assessed by BICR","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}