{"analyses":[{"ciLowerLimit":"0.46","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.73","estimateComment":"Numerator=Pembrolizumab 2 mg/kg Denominator=ICC","groupIds":["OG000","OG002"],"nonInferiorityComment":"Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels \\[≥110% Upper Limit of Normal (ULN)\\]); \\& BRAF mutational status (mutant vs. wild-type)","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.58","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.60","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=ICC","groupIds":["OG001","OG002"],"nonInferiorityComment":"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)","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"One-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.47","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.05","estimateComment":"Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg","groupIds":["OG000","OG001"],"nonInferiorityComment":"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)","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1247","pValueComment":"Two-sided p-value based on stratified log rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"3.8","value":"2.9"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"5.2","value":"3.0"},{"groupId":"OG002","lowerLimit":"2.6","upperLimit":"2.8","value":"2.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"181"},{"groupId":"OG002","value":"179"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.","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":"Progression-free Survival (PFS) - Initial Treatment Period","type":"PRIMARY","unitOfMeasure":"Months"}