{"analyses":[{"ciLowerLimit":"0.278","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.560","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.","paramType":"Hazard Ratio (HR)","paramValue":"0.395","statisticalMethod":"Log Rank","testedNonInferiority":false},{"ciLowerLimit":"0.347","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.702","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.","paramType":"Hazard Ratio (HR)","paramValue":"0.494","statisticalMethod":"Log Rank","testedNonInferiority":false},{"ciLowerLimit":"0.589","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.075","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.134","pValueComment":"The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.","paramType":"Hazard Ratio (HR)","paramValue":"0.796","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit not estimable because of the number of participants without progressive disease at data cut-off.","groupId":"OG000","lowerLimit":"86.14","upperLimit":"NA","value":"136.1"},{"groupId":"OG001","lowerLimit":"56.14","upperLimit":"72.14","value":"62.1"},{"groupId":"OG002","lowerLimit":"52.14","upperLimit":"68.14","value":"56.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"153"},{"groupId":"OG002","value":"154"}],"units":"Participants"}],"description":"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \\[EBMT/IBMTR/ABMTR\\] criteria.\n\nPD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.","dispersionType":"95% Confidence Interval","groups":[{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG000","title":"MPR+R"},{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG001","title":"MPR+p"},{"description":"Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG002","title":"MPp+p"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"up to 165 weeks","title":"Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)","type":"PRIMARY","unitOfMeasure":"weeks"}