{"analyses":[{"ciLowerLimit":"-12.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.2","estimateComment":"This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.","groupDescription":"In participants with strongly PD-L1 positive tumors","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.66608","pValueComment":"P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.","paramType":"Difference in Percentages","paramValue":"-2.3","statisticalMethod":"Miettinen & Nurminen method"},{"ciLowerLimit":"14.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"30.7","estimateComment":"This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.","groupDescription":"In participants with strongly PD-L1 positive tumors","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.00001","pValueComment":"P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.","paramType":"Difference in Percentages","paramValue":"22.2","statisticalMethod":"Miettinen & Nurminen method"},{"ciLowerLimit":"3.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"13.9","estimateComment":"This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.","groupDescription":"In participants with PD-L1 positive tumors","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00045","pValueComment":"P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.","paramType":"Difference in Percentages","paramValue":"8.7","statisticalMethod":"Miettinen & Nurminen method"},{"ciLowerLimit":"4.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.3","estimateComment":"This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.","groupDescription":"In participants with PD-L1 positive tumors","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00024","pValueComment":"P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.","paramType":"Difference in Percentages","paramValue":"9.1","statisticalMethod":"Miettinen & Nurminen method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.7","upperLimit":"38.6","value":"30.2"},{"groupId":"OG001","lowerLimit":"22.0","upperLimit":"37.1","value":"29.1"},{"groupId":"OG002","lowerLimit":"4.1","upperLimit":"13.4","value":"7.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"151"},{"groupId":"OG002","value":"152"}],"units":"Participants"}],"title":"Strongly PD-L1 Positive"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.1","upperLimit":"22.5","value":"18.0"},{"groupId":"OG001","lowerLimit":"14.5","upperLimit":"23.0","value":"18.5"},{"groupId":"OG002","lowerLimit":"6.5","upperLimit":"12.9","value":"9.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"344"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"343"}],"units":"Participants"}],"title":"All PD-L1 Positive"}],"denoms":[{"counts":[{"groupId":"OG000","value":"344"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"343"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.","id":"OG000","title":"Pembrolizumab 2 mg/kg"},{"description":"Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.","id":"OG001","title":"Pembrolizumab 10 mg/kg"},{"description":"Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.","id":"OG002","title":"Docetaxel 75 mg/m^2"}],"paramType":"NUMBER","populationDescription":"Per protocol, ORR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive ORR data available and usable. Participants were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)","title":"Overall Response Rate (ORR) by RECIST 1.1","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}