{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67.6"}]}],"title":"Confirmed complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.4"}]}],"title":"Unconfirmed complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13.5"}]}],"title":"Partial response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.1"}]}],"title":"Stable disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.4"}]}],"title":"Disease progression"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"}]}],"title":"Early death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"}]}],"title":"Inadequate assessment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"}],"units":"Participants"}],"description":"Response rate was defined as the percentage of the EA population who achieved a CR, CRu, or PR. The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease.","groups":[{"description":"Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.","id":"OG000","title":"Denileukin Diftitox in Combination With CHOP"}],"paramType":"NUMBER","populationDescription":"EA population includes all participants who received at least 2 cycles of study drug treatment, were eligible to participate or ineligible with an exception granted by the principal investigator (PI), had bidimensional lesions at baseline, and had at least 1 disease response assessment form submitted following cycle 2.","reportingStatus":"POSTED","timeFrame":"From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months","title":"Overall Response in the Efficacy Analyzable (EA) Population","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}