{"analyses":[{"ciLowerLimit":"0.38","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":"0.00024","paramType":"Hazard Ratio (HR)","paramValue":"0.54","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.70","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":"0.00002","paramType":"Hazard Ratio (HR)","paramValue":"0.50","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.88","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":"0.00076","paramType":"Hazard Ratio (HR)","paramValue":"0.71","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.75","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":"<0.00001","paramType":"Hazard Ratio (HR)","paramValue":"0.61","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of OS not reached, due to insufficient number of deaths in the study.","groupId":"OG000","lowerLimit":"10.4","upperLimit":"NA","value":"14.9"},{"comment":"Upper limit of OS not reached, due to insufficient number of deaths in the study.","groupId":"OG001","lowerLimit":"11.8","upperLimit":"NA","value":"17.3"},{"groupId":"OG002","lowerLimit":"6.4","upperLimit":"10.7","value":"8.2"}]}],"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":"9.4","upperLimit":"11.9","value":"10.4"},{"groupId":"OG001","lowerLimit":"10.0","upperLimit":"17.3","value":"12.7"},{"groupId":"OG002","lowerLimit":"7.5","upperLimit":"9.8","value":"8.5"}]}],"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":"OS was defined as the time from randomization to death due to any cause. OS 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 September (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, OS 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 OS 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 Survival (OS)","type":"PRIMARY","unitOfMeasure":"Months"}