{"classes":[{"categories":[{"measurements":[{"comment":"NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of confidence interval (CI) was not reached.","groupId":"OG000","lowerLimit":"7.622","upperLimit":"NA","value":"NA"},{"comment":"NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of CI was not reached.","groupId":"OG001","lowerLimit":"6.801","upperLimit":"NA","value":"NA"},{"comment":"NA indicates due to the limited follow-up time, most of participants were still alive, so upper limit of CI was not reached.","groupId":"OG002","lowerLimit":"7.392","upperLimit":"NA","value":"12.78"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"36"}],"units":"Participants"}],"description":"OS was defined as the time interval from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever came first. The results provided below corresponds to descriptive OS information at the time of primary analysis completion date of 09 October 2019.","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 Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months","title":"Phase 2: Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}