{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"75"}]}],"title":"Grade 3 or Higher AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"43"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}]}],"title":"AEs Resulting in Treatment Discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"53"}],"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 serious adverse event (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":"In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.","id":"OG000","title":"Phase 2 :Ixazomib 4.0 mg + Lenalidomide + Dexamethasone"},{"description":"In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.","id":"OG001","title":"Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.","reportingStatus":"POSTED","timeFrame":"Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)","title":"Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation","type":"PRIMARY","unitOfMeasure":"percentage of participants"}