{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"263"}],"units":"Participants"}],"description":"The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the SC administration.","groups":[{"description":"Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"OG000","title":"Isa-SC + Pd"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. As pre-specified in the protocol and statistical analysis plan (SAP), ISRs were evaluated only for Isa-SC + Pd arm.","reportingStatus":"POSTED","timeFrame":"From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months","title":"Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)","type":"SECONDARY","unitOfMeasure":"Participants"}