{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"26"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"6"}]}],"title":"During Entire Study Any Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"21"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"5"}]}],"title":"Grade 3 or Higher Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"12"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"1"}]}],"title":"Serious Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"}]}],"title":"Adverse Event With Any Study Drug Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"4"}]}],"title":"Adverse Event With Any Study Drug Reduction"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"26"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"6"}],"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.","groups":[{"description":"Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \\[34 months\\]).","id":"OG000","title":"Arm A: Ixazomib 3.0 mg"},{"description":"Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \\[21 months\\]).","id":"OG001","title":"Arm A: Ixazomib 3.7 mg"},{"description":"Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \\[25 months\\]).","id":"OG002","title":"Arm B: Ixazomib 3.0 mg"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \\[58 months\\]).","id":"OG003","title":"Arm B: Ixazomib 4.0 mg"},{"description":"Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \\[24 months\\]).","id":"OG004","title":"Arm B: Ixazomib 5.5 mg"},{"description":"Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \\[40 months\\]).","id":"OG005","title":"Arm C: Ixazomib 3.0 mg"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \\[24 months\\]).","id":"OG006","title":"Arm C: Ixazomib 4.0 mg"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \\[38 months\\]).","id":"OG007","title":"Arm D: Ixazomib 4.0 mg"}],"paramType":"NUMBER","populationDescription":"The safety population consisted of participants who received at least 1 dose of any study drug.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)","type":"SECONDARY","unitOfMeasure":"participants"}