{"analyses":[{"ciLowerLimit":"11.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"31.5","groupDescription":"ORR per mRECIST - PD-L1 Positive Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00002","pValueComment":"One-sided p-value for testing H0: difference in %=0; H1: difference in %\\>0","paramType":"Difference in Percentages","paramValue":"21.0","statisticalComment":"Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy","statisticalMethod":"Miettinen & Nurminen method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.7","upperLimit":"15.8","value":"9.2"},{"groupId":"OG001","lowerLimit":"20.0","upperLimit":"37.6","value":"28.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"110"}],"units":"Participants"}],"description":"ORR per mRECIST was defined as the percentage of participants in the analysis population who had a CR (complete disappearance of all lesions (and no new lesions), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented) or a PR (decrease in tumor burden ≥50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation). ORR per mRECIST was assessed by BICR in participants with PD-L1 positive tumors (CPS ≥1%) up through the final analysis database cut-off date of 26-Oct-2017.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received paclitaxel 175 mg/m\\^2 intravenously (IV) or docetaxel 75 mg/m\\^2 IV or vinflunine 320 mg/m\\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).","id":"OG000","title":"Control"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).","id":"OG001","title":"Pembrolizumab"}],"paramType":"NUMBER","populationDescription":"The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months)","title":"ORR Per mRECIST - Participants With PD-L1 Positive Tumors","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}