{"analyses":[{"ciLowerLimit":"-4.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"15.8","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"Based on Miettinen \\& Nurminen method stratified by 'Age' (\\<75 years vs \\>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.","pValue":"0.13102","paramType":"Difference in % vs SOC","paramValue":"5.8","statisticalComment":"H0: difference in % =0 versus H1: difference in % \\> 0.","statisticalMethod":"One-sided p-value for testing"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"66.8","upperLimit":"81.0","value":"74.4"},{"groupId":"OG001","lowerLimit":"60.9","upperLimit":"76.0","value":"68.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"154"}],"units":"Participants"}],"description":"ORR was based on participants who achieved at least a partial response (stringent complete response \\[sCR\\]+complete response \\[CR\\]+very good partial response \\[VGPR\\]+partial response \\[PR\\]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \\<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \\<100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24 hours. The data cutoff date was July 9, 2018.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.","id":"OG000","title":"Pembrolizumab + Lenalidomide + Dexamethasone"},{"description":"Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.","id":"OG001","title":"Lenolidomide + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 30 months","title":"Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}