{"analyses":[{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.78","estimateComment":"Based on a stratified Cox proportional hazards model","groupIds":["OG000","OG002"],"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":"0.66","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.63","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.88","estimateComment":"Based on a stratified Cox proportional hazards model","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00067","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.74","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.03","estimateComment":"Based on a stratified Cox proportional hazards model","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.12333","pValueComment":"The p-value is based on the unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.88","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Could not be estimated due to the low number of events at the time of analysis","groupId":"OG000","lowerLimit":"32.8","upperLimit":"NA","value":"39.1"},{"groupId":"OG001","lowerLimit":"26.9","upperLimit":"30.4","value":"28.5"},{"groupId":"OG002","lowerLimit":"24.0","upperLimit":"29.9","value":"26.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"541"},{"groupId":"OG002","value":"547"}],"units":"Participants"}],"description":"Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.","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 includes 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 of 24 May 2013; median follow-up for all participants was 23.0 months","title":"Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)","type":"SECONDARY","unitOfMeasure":"months"}