{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.75","upperLimit":"12.98","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"}],"units":"Participants"}],"description":"PFS was defined as the time interval (in months) from date of first study treatment administration until disease progression or death due to any cause, whichever comes first. In absence of PD or death, PFS was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of \\>=25% in any one of following: serum M-component absolute (abs.) inc. \\>=0.5 g/dL) and/or; urine M-component (abs. inc. \\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein, difference between involved \\& uninvolved FLC levels (abs. inc. \\>10 mg/dL); in participants without measurable serum \\& urine M-protein \\& without measurable disease by FLC levels: bone marrow plasma cell % (abs. % \\>=10%); definite development of new bone lesions or soft tissue plasmacytomas or definite inc. in size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia.","dispersionType":"95% Confidence Interval","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 AEs, 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":"MEDIAN","populationDescription":"Analysis was performed on all treated population. Analysis was performed by Kaplan-Meier method. Data for this outcome measure was not planned to be collected and analyzed for Phase 1.","reportingStatus":"POSTED","timeFrame":"From date of first study treatment administration until disease progression or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)","title":"Phase 2: Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}