{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"description":"Potential DLTs were defined as the occurrence of any of the following adverse reactions at first treatment cycle, unless due to disease progression or obviously unrelated cause: Hematological DLTs: Grade(G) 4 neutropenia (N) for more than 7 consecutive days, G3 to G4 N complicated by fever (temperature greater than or equal to \\[\\>=\\] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention or Non-hematological DLTs: G4 non-hematologic AE, G\\>=2 uveitis, G3 non-hematological AE lasting greater than (\\>)3 days despite optimal care support, delay in initiation of Cycle 2 \\>14 days due to treatment related laboratory abnormalities/AE. Any other AE that the investigator/study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT.","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) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG000","title":"Phase 1: Isatuximab + CemiplimabQ2W"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The DLT evaluable population consisted of participants in Phase 1 who received the planned doses of isatuximab and cemiplimab during Cycle 1, and who completed the DLT observation period of Cycle 1 after the first study treatment administration, unless they discontinued the study treatment(s) due to DLT.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 to Day 28","title":"Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}