{"classes":[{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1, Day 1"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1, Day 11"},{"categories":[{"measurements":[{"comment":"Standard deviation was not estimable for 1 participant.","groupId":"OG002","spread":"NA","value":"0.004"},{"groupId":"OG003","spread":"0.0018","value":"0.006"},{"comment":"Standard deviation was not estimable for 3 participants.","groupId":"OG004","spread":"NA","value":"0.007"},{"comment":"Standard deviation was not estimable for 1 participant.","groupId":"OG005","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1, Day 15"},{"categories":[{"measurements":[{"groupId":"OG005","spread":"0.0021","value":"0.005"},{"comment":"Standard deviation was not estimable for 2 participants.","groupId":"OG006","spread":"NA","value":"0.005"},{"groupId":"OG007","spread":"0.0025","value":"0.006"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"4"}],"units":"Participants"}],"title":"Cycle 1, Day 29"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"5"}],"units":"Participants"}],"description":"Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.","reportingStatus":"POSTED","timeFrame":"Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D","title":"Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)","type":"SECONDARY","unitOfMeasure":"1/hour"}