{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.66","upperLimit":"48.89","value":"30.23"},{"comment":"Here, 'NA' signifies that Median, lower limit and upper limit of 95% confidence interval (CI) could not be estimated due to an insufficient number of participants with events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"193"},{"groupId":"OG001","value":"195"}],"units":"Participants"}],"description":"MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first. Per international amyloidosis consensus criteria (IACC), hematologic progression was defined as satisfying any one of the following criteria: 1) From CHR, abnormal free light chain ratio (light chain must be double and \\>ULN); 2) From CHR/VGPR/PR, 50 percent (%) increase in serum M-protein to \\>0.5 grams per deciliter (g/dL) or 50% increase in urine M-protein to 200 milligrams (mg)/day; 3) free light chain increase of 50% to 100 milligrams (mg)/Liter (L).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).","id":"OG000","title":"CyBorD"},{"description":"Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).","id":"OG001","title":"Daratumumab Plus CyBorD"}],"paramType":"MEDIAN","populationDescription":"The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.","reportingStatus":"POSTED","timeFrame":"From date of first randomization (Day -3) upto 6.5 years","title":"Major Organ Deterioration Progression-Free Survival (MOD-PFS)","type":"SECONDARY","unitOfMeasure":"months"}