{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"20"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"}]}],"title":"SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"AEs Resulting in Treatment Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}]}],"title":"AEs Resulting in Dose Reduction"}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.\n\nA SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.","groups":[{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"OG000","title":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 400 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"OG001","title":"Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population was defined as all participants who receive at least 1 dose of any study drug. Number of participants analyzed is the number of participants who remained on treatment after 13 cycles.","reportingStatus":"POSTED","timeFrame":"First dose of study drug through 30 days after the last dose of drug (Up to 45 months)","title":"Number of Participants With AEs, SAEs, AEs Resulting in Discontinuation and AEs Resulting in Dose Reduction in NDMM Participants Remaining on Treatment After 13 Cycles","type":"SECONDARY","unitOfMeasure":"Participants"}