{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"}],"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. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.","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 1 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 With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation","type":"PRIMARY","unitOfMeasure":"percentage of participants"}