{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.000","upperLimit":"0.000","value":"0"},{"groupId":"OG001","lowerLimit":"0.000","upperLimit":"46.487","value":"16.7"},{"groupId":"OG002","lowerLimit":"27.180","upperLimit":"57.820","value":"42.5"},{"groupId":"OG003","lowerLimit":"25.027","upperLimit":"53.234","value":"39.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"46"}],"units":"Participants"}],"description":"Objective disease response in PTCL was defined as achieving a CR or PR based on the Modified 2007 IWC. A CR = a complete disappearance of all disease; lymph node mass regression to normal size on computerized tomography (CT) scan or negative on positron emission tomography (PET); non-palpable splenic and disappearance of liver nodules; infiltrate cleared on repeat bone marrow (BM), immunohistochemistry negative. PR = a reduction of measurable lesions; ≥ 50% decrease in sum of the products of the greatest diameters (SPD) of up to 6 largest dominant masses, no enlargement in size of other nodes; ≥ 50% decrease in SPD and no increase in liver or spleen.","dispersionType":"95% Confidence Interval","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"},{"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":"Intent to treat population for participants with PTCL who received at least one dose of romidepsin","reportingStatus":"POSTED","timeFrame":"Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015","title":"Percentage of PTCL Participants With the Best Response in Accordance With the Modified 2007 International Workshop Response Criteria as Assessed by IER","type":"SECONDARY","unitOfMeasure":"percentage of participants"}