{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"47"}]}],"title":"Any 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"47"}]}],"title":"TEAE related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"43"}]}],"title":"TEAE with CTCAE Grade 3 or greater"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"43"}]}],"title":"TEAE with CTCAE ≥Grade 3 related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"14"}]}],"title":"≥ 1 serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"10"}]}],"title":"Serious TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"13"}]}],"title":"TEAE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"12"}]}],"title":"TEAE related leading to discontinuation of drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"28"}]}],"title":"TEAE leading to dose held of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"25"}]}],"title":"Related TEAE leading to dose held of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"21"}]}],"title":"TEAE leading to dose reduction of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"21"}]}],"title":"Related TEAE leading to dose reduction of drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"27"}]}],"title":"TEAE leading to dose interruption of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"25"}]}],"title":"Related TEAE leading to dose interruption of drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}]}],"title":"At least one TEAE with NCI CTCAE Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"47"}],"units":"Participants"}],"description":"An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.","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: 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: Romidepsin 14mg/m^2"},{"description":"Romidepsin 14mg/m\\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.","id":"OG002","title":"Phase 2: Romidepsin 14mg/m^2"},{"description":"Romidepsin 14mg/m\\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.","id":"OG003","title":"Total: Romidepsin 14mg/m^2"}],"paramType":"NUMBER","populationDescription":"Safety population includes all participants who received at least one dose of romidepsin","reportingStatus":"POSTED","timeFrame":"Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks","title":"Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin","type":"SECONDARY","unitOfMeasure":"participants"}