{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.77","estimateComment":"Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\\^2","groupDescription":"In participants with strongly PD-L1 positive tumors","groupIds":["OG000","OG002"],"nonInferiorityComment":"Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00009","paramType":"Hazard Ratio (HR)","paramValue":"0.58","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.45","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.78","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\\^2","groupDescription":"In participants with strongly PD-L1 positive tumors","groupIds":["OG001","OG002"],"nonInferiorityComment":"Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00007","paramType":"Hazard Ratio (HR)","paramValue":"0.59","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.04","estimateComment":"Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\\^2","groupDescription":"In participants with PD-L1 positive tumors","groupIds":["OG000","OG002"],"nonInferiorityComment":"Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.06758","paramType":"Hazard Ratio (HR)","paramValue":"0.88","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.94","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\\^2","groupDescription":"In participants with PD-L1 positive tumors","groupIds":["OG001","OG002"],"nonInferiorityComment":"Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00462","paramType":"Hazard Ratio (HR)","paramValue":"0.79","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.0","upperLimit":"6.5","value":"5.2"},{"groupId":"OG001","lowerLimit":"4.1","upperLimit":"8.1","value":"5.2"},{"groupId":"OG002","lowerLimit":"3.6","upperLimit":"4.3","value":"4.1"}]}],"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":"3.1","upperLimit":"4.1","value":"3.9"},{"groupId":"OG001","lowerLimit":"2.6","upperLimit":"4.3","value":"4.0"},{"groupId":"OG002","lowerLimit":"3.1","upperLimit":"4.2","value":"4.0"}]}],"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":"PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \\>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary 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":"MEDIAN","populationDescription":"Per protocol, PFS 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 PFS 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":"Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","type":"PRIMARY","unitOfMeasure":"Months"}