{"analyses":[{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.92","estimateComment":"Based on a stratified Cox proportional hazards model","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00234","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.86","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.20","estimateComment":"Based on a stratified Cox proportional hazards model","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.82903","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"1.02","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.90","estimateComment":"Based on a stratified Cox proportional hazards model","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00119","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.77","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53.9","upperLimit":"65.9","value":"59.1"},{"groupId":"OG001","lowerLimit":"53.6","upperLimit":"68.7","value":"62.3"},{"groupId":"OG002","lowerLimit":"44.3","upperLimit":"53.5","value":"49.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"541"},{"groupId":"OG002","value":"547"}],"units":"Participants"}],"description":"Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.","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":"ITT population included all participants who were randomized, independent of whether they received study treatment or not.","reportingStatus":"POSTED","timeFrame":"From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months","title":"Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)","type":"SECONDARY","unitOfMeasure":"months"}