{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"7"}],"units":"Participants"}],"description":"Dose limiting toxicity (DLT) was defined as a toxicity requiring treatment withdrawal and included the following: Non-hematologic toxicity qualifying for DLT and Hematologic toxicity qualifying for DLT","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":"OG000","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":"OG001","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":"OG002","title":"PAN + 5-Aza 40 mg"}],"paramType":"NUMBER","populationDescription":"Maximum Tolerated Dose (MTD) determining set: Consisted of all patients of the safety set who either received sufficient study treatment as defined in the minimum exposure criteria in Cycle 1 (patients had to have 100% of the planned dose of each compound), and had sufficient safety evaluations or discontinued due to DLT in Cycle 1.","reportingStatus":"POSTED","timeFrame":"within the first 28 days (cycle 1)","title":"Number of Dose Limiting Toxicity (DLT) (Phase lb)","type":"PRIMARY","unitOfMeasure":"DLTs"}