{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.739","upperLimit":"11.368","value":"10.28"},{"groupId":"OG001","lowerLimit":"8.016","upperLimit":"11.072","value":"8.84"},{"groupId":"OG002","lowerLimit":"8.016","upperLimit":"10.875","value":"9.03"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"36"}],"units":"Participants"}],"description":"Duration of follow-up was defined as the date of randomization to the date of last contact or death, whichever came first. Median duration of follow-up is reported.","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":"MEDIAN","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 the date of randomization up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months","title":"Phase 2: Duration of Follow-up","type":"SECONDARY","unitOfMeasure":"months"}