{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"}],"units":"Participants"}],"description":"Percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed by International Myeloma Working Group (IMWG) uniform response criteria. sCR: CR as defined plus normal FLC ratio \\& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \\& urine; disappearance of any soft tissue plasmacytomas; \\<5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \\& urine M-protein detectable by immunofixation; \\>=90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24 h; \\>90% decrease in difference between involved \\& uninvolved FLC levels required. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M protein by \\>=90%/\\<200 mg/24 h; if serum \\& urine M-protein unmeasurable:\\>=50% decrease in difference between involved \\& uninvolved FLC; if serum \\& urine M-protein not measurable:\\>=50% reduction in plasma cells required, in place of M-protein.","groups":[{"description":"Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).","id":"OG000","title":"Phase 2: Isatuximab 20 mg/kg"}],"paramType":"NUMBER","populationDescription":"Analysis was performed on all treated population.","reportingStatus":"POSTED","timeFrame":"From the date of the first response until the primary analysis data cut-off date of 31 July 2018 (median duration of follow-up was 24.14 weeks)","title":"Phase 2: Percentage of Participants With Overall Response (OR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}