{"classes":[{"categories":[{"measurements":[{"comment":"Here NA signifies that Median and 95% CI was not estimable due to insufficient number of events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Here NA signifies that Median and 95% CI was not estimable due to insufficient number of events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Here NA signifies that Median and upper limit of 95% CI was not estimable due to insufficient number of events.","groupId":"OG002","lowerLimit":"56.8","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"16"}],"units":"Participants"}],"description":"Duration of response is defined as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be \\>= 0.5 g/dL and \\>=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \\> 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.","dispersionType":"95% Confidence Interval","groups":[{"description":"Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy \\[HDT\\] and autologous stem cell transplantation \\[ASCT\\]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m\\^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week \\[until disease progression/up to maximum of 2 years\\])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.","id":"OG000","title":"Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)"},{"description":"Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \\[until disease progression/up to maximum of 2 years\\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator.","id":"OG001","title":"Randomized: Daratumumab+RVd (D-RVd)"},{"description":"Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \\[until disease progression/up to maximum of 2 years\\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.","id":"OG002","title":"Safety Run-in: D-RVd"}],"paramType":"MEDIAN","populationDescription":"Population analyzed included response evaluable analysis set who achieved response PR or better.","reportingStatus":"POSTED","timeFrame":"From the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive (up to 5 years)","title":"Duration of Response","type":"SECONDARY","unitOfMeasure":"Months"}