{"analyses":[{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.28","estimateComment":"Numerator=Pembrolizumab 2 mg/kg Denominator=ICC","groupDescription":"Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \\[≥110% ULN\\]); \\& BRAF mutational status (mutant vs. wild-type)","groupIds":["OG000","OG002"],"nonInferiorityComment":"PD-L1-Positive Participants","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3113","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.92","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.99","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=ICC","groupDescription":"Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \\[≥110% ULN\\]); \\& BRAF mutational status (mutant vs. wild-type)","groupIds":["OG001","OG002"],"nonInferiorityComment":"PD-L1 Positive Participants","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0208","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.70","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg","groupDescription":"Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \\[≥110% ULN\\]); \\& BRAF mutational status (mutant vs. wild-type)","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 Positive Participants","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0496","pValueComment":"Two-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.71","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.76","estimateComment":"Numerator=Pembrolizumab 2 mg/kg Denominator=ICC","groupDescription":"Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \\[≥110% ULN\\]); \\& BRAF mutational status (mutant vs. wild-type)","groupIds":["OG000","OG002"],"nonInferiorityComment":"PD-L1 Negative Participants","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.6043","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"1.07","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.04","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=ICC","groupDescription":"Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \\[≥110% ULN\\]); \\& BRAF mutational status (mutant vs. wild-type)","groupIds":["OG001","OG002"],"nonInferiorityComment":"PD-L1 Negative Participants","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0335","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.44","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.13","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg","groupDescription":"Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \\[≥110% ULN\\]); \\& BRAF mutational status (mutant vs. wild-type)","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 Negative Participants","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1504","pValueComment":"Two-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.71","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.9","upperLimit":"20.9","value":"15.0"},{"groupId":"OG001","lowerLimit":"13.7","upperLimit":"28.9","value":"17.5"},{"groupId":"OG002","lowerLimit":"7.7","upperLimit":"18.2","value":"12.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"98"}],"units":"Participants"}],"title":"PD-L1 Positive"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.4","upperLimit":"13.5","value":"10.5"},{"groupId":"OG001","lowerLimit":"4.6","upperLimit":"23.3","value":"13.4"},{"groupId":"OG002","lowerLimit":"5.1","upperLimit":"14.2","value":"9.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"40"}],"units":"Participants"}],"title":"PD-L1 Negative"}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"181"},{"groupId":"OG002","value":"179"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \\~66 months)","id":"OG000","title":"Pembrolizumab 2 mg/kg"},{"description":"Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \\~66 months)","id":"OG001","title":"Pembrolizumab 10 mg/kg"},{"description":"Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \\~66 months)","id":"OG002","title":"Investigator-Choice Chemotherapy (ICC)"}],"paramType":"MEDIAN","populationDescription":"The analysis population consisted of all randomized participants who had a PD-L1 tumor expression status assessment. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)","title":"Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period","type":"SECONDARY","unitOfMeasure":"Months"}