{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.9634","value":"33.515"},{"groupId":"OG001","spread":"26.6436","value":"46.946"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"title":"Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9559","value":"58.674"},{"groupId":"OG001","spread":"23.5112","value":"51.832"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"title":"Day 11"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.","dispersionType":"Standard Deviation","groups":[{"description":"Ixazomib 3 mg, 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 1. 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 was 83 cycles (approximately up to 2037 days).","id":"OG000","title":"Phase 1: Ixazomib 3 mg"},{"description":"Ixazomib (MLN9708) 3.7 mg, 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 1. 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 25 cycles (approximately 585 days).","id":"OG001","title":"Phase 1: Ixazomib 3.7 mg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.","reportingStatus":"POSTED","timeFrame":"Cycle 1, Days 1 and 11","title":"Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib","type":"SECONDARY","unitOfMeasure":"nanogram per milliliter (ng/mL)"}