{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"DLT was defined as an adverse event (AE) occurring in Cycle 1 in Phase 1 and judged that the causal relationship to the investigational product could not be denied. The severity of all AEs was graded based upon the NCI CTCAE version 3.0. DLTs were defined as: • Grade 4 Hemoglobin \\<6.5 g/dL • Grade 4 Neutrophil \\<500/μL continuing for at least 5 days • Febrile neutropenia (Grade 4 neutropenia caused by fever and ≥ 38.5° C for more than 1 hour) • Grade 4 thrombocyte (\\< 25,000/μL), or thrombocytopenia with hemorrhage requiring platelet transfusion • Nausea, vomiting, or diarrhea at \\> grade 3 in spite of treatment • Grade 3 ALT (alanine aminotransferase) or AST (aspartate aminotransferase) values continued for 7 days. • Grade 4 ALT or AST • Grade 2 arrhythmia • Grade 4 non-hematological AEs • Other grade 3 non-hematological AEs except transient fatigue, anorexia, hyponatremia, and tumor lysis syndrome • Other AEs leading to discontinuation of administration","groups":[{"description":"Romidepsin 9mg/m\\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle","id":"OG000","title":"Phase 1: Cohort 1: Romidepsin 9mg/m^2"},{"description":"Romidepsin 14mg/m\\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.","id":"OG001","title":"Phase 1: Cohort 2: Romidepsin 14mg/m^2"}],"paramType":"NUMBER","populationDescription":"DLT population included all participants in the Phase 1 portion who received at least one dose of romidepsin. Of 8 participants enrolled in the 14mg/m\\^2 cohort, 2 participants, one with a critical Good Clinical Practice (GCP)violation and the other who did not complete Cycle 1 due to consent withdrawal, were excluded from the DLT assessment.","reportingStatus":"POSTED","timeFrame":"Up to Day 28; Cycle 1","title":"Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC)","type":"PRIMARY","unitOfMeasure":"participants"}