{"analyses":[{"ciLowerLimit":"0.61","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.85","estimateComment":"Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00006","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.72","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.60","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.82","estimateComment":"Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00001","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.70","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.89","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.20","estimateComment":"Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.70349","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"1.03","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.7","upperLimit":"29.4","value":"25.5"},{"groupId":"OG001","lowerLimit":"19.4","upperLimit":"22.0","value":"20.7"},{"groupId":"OG002","lowerLimit":"19.3","upperLimit":"23.2","value":"21.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"541"},{"groupId":"OG002","value":"547"}],"units":"Participants"}],"description":"PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.","id":"OG000","title":"Lenalidomide and Low-Dose Dexamethasone (Rd)"},{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.","id":"OG001","title":"Lenalidomide and Dexamethasone Rd18"},{"description":"Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.","id":"OG002","title":"Melphalan + Prednisone + Thalidomide (MPT)"}],"paramType":"MEDIAN","populationDescription":"The intent to treat (ITT) population included all participants who were randomized, independent of whether they received study treatment or not.","reportingStatus":"POSTED","timeFrame":"From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.","title":"Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)","type":"PRIMARY","unitOfMeasure":"months"}