{"analyses":[{"ciLowerLimit":"1.08","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.08","estimateComment":"Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.99324","paramType":"Hazard Ratio (HR)","paramValue":"1.50","statisticalComment":"One-sided p-value based on Stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.5","upperLimit":"7.5","value":"5.7"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"11.5","value":"7.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"description":"Progression free survival was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS was assessed by CAC blinded central review according to the IMWG criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The database cutoff date was July 9, 2018.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.","id":"OG000","title":"Pembrolizumab+Pomalidomide+Dexamethasone"},{"description":"Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.","id":"OG001","title":"Standard of Care (SOC) Pomalidomide+Dexamethasone"}],"paramType":"MEDIAN","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":"Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria","type":"PRIMARY","unitOfMeasure":"Months"}