{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"175"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"129"}]}],"title":"Any treatment emergent SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"177"}],"units":"Participants"}],"description":"Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE was 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.","groups":[{"description":"Participants received carfilzomib 20 mg/m\\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).","id":"OG000","title":"Carfilzomib + Dexamethasone (Kd)"},{"description":"Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).","id":"OG001","title":"Isatuximab + Carfilzomib + Dexamethasone (IKd)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Analysis was performed on safety population which included all who gave their informed consent and for whom there was confirmation of successful allocation of a randomization number by the IRT and received at least one dose or a part of a dose of the study treatments.","reportingStatus":"POSTED","timeFrame":"From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to 349 weeks for Kd arm and 356 weeks for IKd arm (maximum duration of treatment exposure)","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): LPLV Analysis","type":"SECONDARY","unitOfMeasure":"Participants"}