{"groups":[{"description":"POM (Pomalidomide)\n\n* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)\n* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle\n* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)\n* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.\n* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.","id":"FG000","title":"Treatment 1: POM+BTZ+LD-DEX"},{"description":"BTZ ((Bortezomib)\n\n* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle\n* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)\n* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.\n* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.","id":"FG001","title":"Treatment 2: BTZ+LD-DEX"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"clinical progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"Withdrew informed consent"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Randomization error"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"281"},{"groupId":"FG001","numSubjects":"278"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"278"},{"groupId":"FG001","numSubjects":"270"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"8"}],"type":"NOT COMPLETED"}],"title":"Randomization"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"167"},{"groupId":"FG001","numSubjects":"165"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"52"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"22"}],"type":"Withdrawal of Consent"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"9"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"19"}],"type":"Other Reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Pregnancy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"278"},{"groupId":"FG001","numSubjects":"270"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"278"},{"groupId":"FG001","numSubjects":"270"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"}],"preAssignmentDetails":"548 participants treated"}