{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"3"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}],"title":"SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"3"}],"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 1, ixazomib 1.68 mg/m\\^2, 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 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.","id":"OG000","title":"Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone"},{"description":"In phase 1, ixazomib 2.23 mg/m\\^2, 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 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.","id":"OG001","title":"Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone"},{"description":"In phase 1, ixazomib 2.97 mg/m\\^2, 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 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.","id":"OG002","title":"Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone"},{"description":"In phase 1, ixazomib 3.95 mg/m\\^2, 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 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.","id":"OG003","title":"Phase 1: Ixazomib 3.95 mg/m^2 + 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 336 days)","title":"Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability","type":"PRIMARY","unitOfMeasure":"participants"}