{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.745","upperLimit":"12.977","value":"5.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"}],"units":"Participants"}],"description":"TTP: time interval (in months) from date of first study treatment administration to date of first assessed disease progression. In absence of disease progression, TTP 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% from lowest response value in any one of following: serum M-component (absolute inc.\\>=0.5 g/dL) and/or; urine M-component (absolute inc.\\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein: difference between involved \\& uninvolved FLC levels (absolute inc.\\>10 mg/dL); in participants without measurable serum \\& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute% \\>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/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: Time to Progression (TTP)","type":"SECONDARY","unitOfMeasure":"months"}