{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.0"}]}],"title":"Confirmed complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Unconfirmed complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10.2"}]}],"title":"Partial response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6.1"}]}],"title":"Stable disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Disease progression"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Early death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.4"}]}],"title":"Inadequate assessment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"description":"Response rate was defined as the percentage of the ITT population who achieved a Complete Response (CR), Unconfirmed Complete Response (CRu), or Partial Response (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":"Intent to treat (ITT) population included all participants who signed an informed consent and were deemed eligible to participate by the investigator based on the screening assessments, and started at least 1 cycle of study treatment. It is the same as the Safety Population (SP) for this study.","reportingStatus":"POSTED","timeFrame":"From the start of the treatment to the date of participant's death assessed up to 5 years 9 months","title":"Overall Response in the Intent To Treat (ITT) Population","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}