{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28.9"},{"groupId":"OG001","value":"20.0"}]}],"title":"Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37.8"},{"groupId":"OG001","value":"28.9"}]}],"title":"Life-threatening"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.0"},{"groupId":"OG001","value":"31.1"}]}],"title":"Severe"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.9"},{"groupId":"OG001","value":"17.8"}]}],"title":"Moderate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2"},{"groupId":"OG001","value":"0"}]}],"title":"Mild"}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"45"}],"units":"Participants"}],"description":"The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.","groups":[{"description":"Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)","id":"OG000","title":"Phase II: VR-DA-EPOCH"},{"description":"Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat","id":"OG001","title":"Phase II: DA-R-EPOCH"}],"paramType":"NUMBER","populationDescription":"Eligible randomized participants","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}