{"denoms":[{"counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"42"},{"groupId":"BG005","value":"113"}],"units":"Participants"}],"groups":[{"description":"In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.","id":"BG000","title":"PAN + 5-Aza 20 mg"},{"description":"In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.","id":"BG001","title":"PAN + 5-Aza 30 mg"},{"description":"In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.","id":"BG002","title":"PAN + 5-Aza 40 mg"},{"description":"In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.\n\nIn both phases, dose of 5-Azacytidine was 75 mg/m\\^2, subcutaneously Daily for Day 1 to Day 7.","id":"BG003","title":"Panobinostat + 5-Azacytidine"},{"description":"The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.\n\nDose of 5-Azacytidine : 75 mg/m\\^2 subcutaneously daily from Day 1 to Day 7.","id":"BG004","title":"5-Azacytidine"},{"description":"Total of all reporting groups","id":"BG005","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"29"}]}],"title":"< 65"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"26"},{"groupId":"BG004","value":"34"},{"groupId":"BG005","value":"84"}]}],"title":">= 65"}],"paramType":"NUMBER","title":"Age, Customized","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"17"},{"groupId":"BG005","value":"44"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"25"},{"groupId":"BG005","value":"69"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"36"},{"groupId":"BG005","value":"91"}]}],"title":"Caucasian"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"2"}]}],"title":"Black"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"9"}]}],"title":"Asian"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"11"}]}],"title":"Other"}],"paramType":"NUMBER","title":"Race/Ethnicity, Customized","unitOfMeasure":"participants"}],"populationDescription":"Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms"}