{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.50","upperLimit":"1.50","value":"1.50"},{"groupId":"OG001","lowerLimit":"1.53","upperLimit":"1.53","value":"1.53"},{"groupId":"OG002","lowerLimit":"1.03","upperLimit":"2.00","value":"1.52"},{"groupId":"OG003","lowerLimit":"1.00","upperLimit":"1.00","value":"1.00"},{"groupId":"OG004","lowerLimit":"1.00","upperLimit":"2.00","value":"1.52"},{"groupId":"OG005","lowerLimit":"1.00","upperLimit":"1.50","value":"1.25"},{"groupId":"OG006","lowerLimit":"0.50","upperLimit":"4.00","value":"1.00"},{"groupId":"OG007","lowerLimit":"0.53","upperLimit":"1.50","value":"1.00"},{"groupId":"OG008","lowerLimit":"0.50","upperLimit":"2.00","value":"2.00"},{"groupId":"OG009","lowerLimit":"0.50","upperLimit":"2.00","value":"0.50"},{"groupId":"OG010","lowerLimit":"0.50","upperLimit":"1.42","value":"1.00"},{"groupId":"OG011","lowerLimit":"1.00","upperLimit":"1.53","value":"1.42"}]}],"title":"Cycle 1 Day 1 (n=1,1,2,1,3,2,5,4,5,8,5,3)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.00","upperLimit":"2.00","value":"1.07"},{"groupId":"OG001","lowerLimit":"0.50","upperLimit":"0.50","value":"0.50"},{"groupId":"OG002","lowerLimit":"1.00","upperLimit":"2.00","value":"1.83"},{"groupId":"OG003","lowerLimit":"1.00","upperLimit":"1.00","value":"1.00"},{"groupId":"OG004","lowerLimit":"1.00","upperLimit":"1.53","value":"1.27"},{"groupId":"OG005","lowerLimit":"8.00","upperLimit":"8.00","value":"8.00"},{"groupId":"OG006","lowerLimit":"0.50","upperLimit":"2.00","value":"1.25"},{"groupId":"OG007","lowerLimit":"1.03","upperLimit":"1.03","value":"1.03"},{"groupId":"OG008","lowerLimit":"1.00","upperLimit":"4.03","value":"1.50"},{"groupId":"OG009","lowerLimit":"0.50","upperLimit":"1.50","value":"1.00"},{"groupId":"OG010","lowerLimit":"0.50","upperLimit":"1.50","value":"1.00"},{"groupId":"OG011","lowerLimit":"1.00","upperLimit":"4.00","value":"1.03"}]}],"title":"Cycle 1 Day 15 (n=3,1,3,2,2,1,2,1,5,5,4,3)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"4"},{"groupId":"OG008","value":"7"},{"groupId":"OG009","value":"8"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"3"}],"units":"Participants"}],"description":"Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).","dispersionType":"Full Range","groups":[{"description":"Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG000","title":"0.24 mg/m^2"},{"description":"Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG001","title":"0.48 mg/m^2"},{"description":"Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG002","title":"0.80 mg/m^2"},{"description":"Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG003","title":"1.20 mg/m^2"},{"description":"Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG004","title":"1.68 mg/m^2"},{"description":"Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG005","title":"2.23 mg/m^2"},{"description":"Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG006","title":"2.97 mg/m^2"},{"description":"Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG007","title":"3.95 mg/m^2"},{"description":"Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG008","title":"Relapsed and Refractory (RR)"},{"description":"Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG009","title":"VELCADE-relapsed (VR)"},{"description":"Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG010","title":"PI naïve"},{"description":"Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.","id":"OG011","title":"Carfilzomib"}],"paramType":"MEDIAN","populationDescription":"Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.","reportingStatus":"POSTED","timeFrame":"Days 1 and 15 of Cycle 1","title":"Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238","type":"SECONDARY","unitOfMeasure":"hours"}