{"analyses":[{"groupIds":["OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)","statisticalMethod":"Binomial test for dichotomized response"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.000","upperLimit":"0.000","value":"0"},{"groupId":"OG001","lowerLimit":"28.947","upperLimit":"100.000","value":"66.7"},{"groupId":"OG002","lowerLimit":"27.180","upperLimit":"57.820","value":"42.5"},{"groupId":"OG003","lowerLimit":"31.258","upperLimit":"60.046","value":"45.7"}]}]}],"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 patients with a complete response (CR), unconfirmed complete response (CRu) or a partial response (PR) according to modified IWC 1999 criteria and assessed by an independent efficacy reviewer. A CR is \\>75% decrease in size of maximum 6 largest target within nodal and extranodal lesions, complete disappearance of other nodal and extranodal; total disappearance of clinical disease; disease-related signs and symptoms, normalization of biochemical abnormalities, disappearance of spleen, liver, or kidney enlargement; no bone marrow (BM) involvement, no new sites of disease. CRu: all above criteria fulfilled except for BM involvement is indeterminate. PR: a ≥50% decrease in size of 6 largest target lesions and no increase other nodal and extranodal; no progression of clinical disease; disease-related signs and symptoms, normalization or biochemical abnormalities, no progression in size of liver, spleen, or kidney; and no new sites of disease","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: 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":"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 an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2","type":"PRIMARY","unitOfMeasure":"percentage of participants"}