{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.75","upperLimit":"41.17","value":"23.5"},{"groupId":"OG001","lowerLimit":"20.82","upperLimit":"53.78","value":"36.1"},{"groupId":"OG002","lowerLimit":"23.14","upperLimit":"56.54","value":"38.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"36"}],"units":"Participants"}],"description":"CBR by Investigator using IMWG response criteria: percentage of participants with CR (including sCR), VGPR, PR (all defined in previous OM) or MR. MR was defined as \\>= 25% but \\<= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceeded 200 mg/24h; if present at baseline, \\>=50% reduction in size (SPD) of soft tissue plasmacytomas was also required.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG000","title":"Phase 2: Isatuximab"},{"description":"Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG001","title":"Phase 2: Isatuximab + CemiplimabQ2W"},{"description":"Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG002","title":"Phase 2: Isatuximab + CemiplimabQ4W"}],"paramType":"NUMBER","populationDescription":"The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.","reportingStatus":"POSTED","timeFrame":"From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months","title":"Phase 2: Percentage of Participants With Clinical Benefit Rate (CBR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}