{"denoms":[{"counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"193"},{"groupId":"BG002","value":"195"},{"groupId":"BG003","value":"416"}],"units":"Participants"}],"groups":[{"description":"Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. 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":"BG000","title":"Run-In: Daratumumab Plus CyBorD"},{"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":"BG001","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":"BG002","title":"Daratumumab Plus CyBorD"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"11.2","value":"64.8"},{"groupId":"BG001","spread":"9.66","value":"64"},{"groupId":"BG002","spread":"10.16","value":"62.2"},{"groupId":"BG003","spread":"10.03","value":"63.2"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"87"},{"groupId":"BG003","value":"174"}]}],"title":"Female"},{"categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"117"},{"groupId":"BG002","value":"108"},{"groupId":"BG003","value":"241"}]}],"title":"Male"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}],"title":"Undifferentiated Sex"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex/Gender, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"23"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"176"},{"groupId":"BG002","value":"179"},{"groupId":"BG003","value":"381"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"12"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"64"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"15"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"143"},{"groupId":"BG002","value":"151"},{"groupId":"BG003","value":"319"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"13"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"27"}]}],"title":"AUSTRALIA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}]}],"title":"BELGIUM"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"11"}]}],"title":"BRAZIL"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"19"}]}],"title":"CANADA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"12"}]}],"title":"CHINA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]}],"title":"DENMARK"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"38"}]}],"title":"FRANCE"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"19"}]}],"title":"GERMANY"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"27"}]}],"title":"GREECE"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}],"title":"HUNGARY"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"11"}]}],"title":"ISRAEL"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"9"}]}],"title":"ITALY"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"28"}]}],"title":"JAPAN"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]}],"title":"MEXICO"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"11"}]}],"title":"NETHERLANDS"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}],"title":"POLAND"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"20"}]}],"title":"SOUTH KOREA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"32"}]}],"title":"SPAIN"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}]}],"title":"SWEDEN"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"17"}]}],"title":"TURKEY"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"8"}]}],"title":"UNITED KINGDOM"},{"categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"40"},{"groupId":"BG003","value":"109"}]}],"title":"UNITED STATES"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"62"},{"groupId":"BG003","value":"141"}]}],"title":"<=65 kg"},{"categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"96"},{"groupId":"BG003","value":"182"}]}],"title":">65 to 85 kg"},{"categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"93"}]}],"title":">85 kg"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Weight group in Kilograms (Kg)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"137"},{"groupId":"BG002","value":"140"},{"groupId":"BG003","value":"294"}]}],"title":"Baseline Organ Involvement: Heart"},{"categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"114"},{"groupId":"BG002","value":"115"},{"groupId":"BG003","value":"248"}]}],"title":"Baseline Organ Involvement: Kidney"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"35"}]}],"title":"Baseline Organ Involvement: Liver"}],"description":"Organ involvement assessment: biopsy. Heart: echo: mean wall thickness greater than (\\>) 12 millimeter, no other cardiac cause; kidney: 24- hour urine protein \\>0.5 gram per day, predominantly albumin; liver: total liver span \\>15 centimeter in absence of heart failure or alkaline phosphatase \\>1.5 times institutional upper limit of normal.","paramType":"COUNT_OF_PARTICIPANTS","title":"Baseline Major Organ Involvement","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"0.881","value":"2.0"},{"groupId":"BG001","spread":"1.03","value":"2.0"},{"groupId":"BG002","spread":"0.97","value":"2.0"},{"groupId":"BG003","spread":"0.99","value":"2.0"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Number of Organs Involved","unitOfMeasure":"organs"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"66"},{"groupId":"BG003","value":"143"}]}],"title":"1 Organ"},{"categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"166"}]}],"title":"2 Organs"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"53"},{"groupId":"BG003","value":"107"}]}],"title":">=3 Organ"}],"description":"Number of participants whose 1 organ, 2 organs, 3 or more than 3 organs involved at baseline was reported. Organs like heart, kidney, and liver were considered.","paramType":"COUNT_OF_PARTICIPANTS","title":"Number of Organs Involved","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"47"},{"groupId":"BG003","value":"96"}]}],"title":"Class I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"80"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"172"}]}],"title":"Class II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"64"},{"groupId":"BG002","value":"70"},{"groupId":"BG003","value":"139"}]}],"title":"Class IIIa"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"9"}]}],"title":"Class IIIb"}],"description":"Cardiac stage is derived based on the combination of NT-proBNP (N-terminal pro b-type natriuretic peptide) and hs-cTnT (high sensitivity cardiac troponin T). Risk factor includes NT-proBNP \\>332 nanogram per liter (ng/L) and Hs-cTnT \\>54 ng/L. Stage I includes no markers above the cutoff, stage 2 includes one marker above the cutoff, stage 3a includes both markers above the cutoff, and stage 3b includes NT-proBNP \\>8500 ng/L and hs-cTnT \\>54 ng/L.","paramType":"COUNT_OF_PARTICIPANTS","title":"Cardiac Stage Based on Mayo Clinic Cardiac Staging System","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"94"},{"groupId":"BG002","value":"101"},{"groupId":"BG003","value":"212"}]}],"title":"Class I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"89"},{"groupId":"BG002","value":"77"},{"groupId":"BG003","value":"176"}]}],"title":"Class II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"28"}]}],"title":"Class IIIA"}],"description":"The NYHA classification: Class I- No symptoms and no limitation in ordinary physical activity, example, shortness of breath when walking, climbing stairs; class II- mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; class IIIA- marked limitation in activity due to symptoms, even during less than ordinary activity, example, walking short distances (20-100 meter).Comfortable only at rest.","paramType":"COUNT_OF_PARTICIPANTS","title":"New York Heart Association (NYHA) Class","unitOfMeasure":"Participants"}]}