{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"41"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"45"}],"units":"Participants"}],"description":"An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.","groups":[{"description":"Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","id":"OG000","title":"[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy"},{"description":"Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","id":"OG001","title":"[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy"},{"description":"Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","id":"OG002","title":"[Overall]; Combination Therapy + Ixazomib Therapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set: all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.","reportingStatus":"POSTED","timeFrame":"Up to 39 months as a maximum","title":"Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}