{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"TESAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs are defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Analysis was performed on all treated population.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 248 weeks)","title":"Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}