{"analyses":[{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.10","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"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1173","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.86","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.57","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.96","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"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0106","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.74","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.12","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"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.2905","pValueComment":"Two-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.87","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.0","upperLimit":"16.4","value":"13.4"},{"groupId":"OG001","lowerLimit":"11.3","upperLimit":"19.5","value":"14.7"},{"groupId":"OG002","lowerLimit":"8.9","upperLimit":"13.8","value":"11.0"}]}]}],"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. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.","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. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)","title":"Interim Overall Survival (OS) - Initial Treatment Period","type":"PRIMARY","unitOfMeasure":"Months"}