{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"46"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"}],"units":"Participants"}],"description":"A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.","groups":[{"description":"Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 74 cycles (approximately 1875 days).","id":"OG000","title":"Phase 2: Ixazomib 3 mg"}],"paramType":"NUMBER","populationDescription":"Safety population included all participants who received at least one dose of any study drug.","reportingStatus":"POSTED","timeFrame":"Baseline up to 30 days after the last dose of study drug (approximately 1905 days)","title":"Phase 2: Percentage of Participants Experiencing Serious Adverse Events","type":"PRIMARY","unitOfMeasure":"percentage of participants"}