{"denoms":[{"counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"50"},{"groupId":"BG005","value":"65"}],"units":"Participants"}],"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":"BG000","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":"BG001","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":"BG002","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":"BG003","title":"Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone"},{"description":"In phase 2, ixazomib 4.0 mg fixed dose, 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 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.","id":"BG004","title":"Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone"},{"description":"Total of all reporting groups","id":"BG005","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"3.21","value":"62.7"},{"groupId":"BG001","spread":"4.51","value":"72.3"},{"groupId":"BG002","spread":"12.19","value":"63.2"},{"groupId":"BG003","spread":"9.29","value":"64.7"},{"groupId":"BG004","spread":"11.16","value":"64.2"},{"groupId":"BG005","spread":"10.67","value":"64.4"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"29"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"30"},{"groupId":"BG005","value":"36"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"1"}]}],"title":"Hispanic or Latino"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"49"},{"groupId":"BG005","value":"64"}]}],"title":"Not Hispanic or Latino"}],"paramType":"NUMBER","title":"Race/Ethnicity, Customized","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"42"},{"groupId":"BG005","value":"52"}]}],"title":"White"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"12"}]}],"title":"Black or African American"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"1"}]}],"title":"Asian"}],"paramType":"NUMBER","title":"Race/Ethnicity, Customized","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"50"},{"groupId":"BG005","value":"65"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"50"},{"groupId":"BG005","value":"65"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"12.90","value":"168.9"},{"groupId":"BG001","spread":"3.20","value":"155.4"},{"groupId":"BG002","spread":"10.21","value":"165.9"},{"groupId":"BG003","spread":"8.07","value":"171.1"},{"groupId":"BG004","spread":"11.57","value":"169.4"},{"groupId":"BG005","spread":"11.30","value":"168.5"}]}]}],"description":"Height data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Height","unitOfMeasure":"cm"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"12.683","value":"87.43"},{"groupId":"BG001","spread":"16.045","value":"64.93"},{"groupId":"BG002","spread":"14.557","value":"72.82"},{"groupId":"BG003","spread":"25.480","value":"116.63"},{"groupId":"BG004","spread":"17.695","value":"86.13"},{"groupId":"BG005","spread":"19.247","value":"85.39"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Weight","unitOfMeasure":"kg"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"0.2180","value":"2.024"},{"groupId":"BG001","spread":"0.1923","value":"1.665"},{"groupId":"BG002","spread":"0.2272","value":"1.826"},{"groupId":"BG003","spread":"0.3050","value":"2.348"},{"groupId":"BG004","spread":"0.2343","value":"2.011"},{"groupId":"BG005","spread":"0.2565","value":"1.994"}]}]}],"description":"Body surface area is defined as \\[Height(cm) x Weight (kg)\\]/3600)\\^1/2. Body surface area data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Body Surface Area","unitOfMeasure":"m^2"}],"populationDescription":"Safety Analysis Population: all participants who received at least one dose of any of the 3 study drugs."}