{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63.3"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46.9"}]}],"title":"Nausea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40.8"}]}],"title":"Hemoglobin"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40.8"}]}],"title":"Neuropathy-sensory"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34.7"}]}],"title":"Alanine transaminase"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34.7"}]}],"title":"Hyperglycemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34.7"}]}],"title":"Hypoalbuminemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34.7"}]}],"title":"Leukocytes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32.7"}]}],"title":"Fever"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30.6"}]}],"title":"Hypocalcemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30.6"}]}],"title":"Lymphopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28.6"}]}],"title":"Aspartate transaminase"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28.6"}]}],"title":"Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28.6"}]}],"title":"Platelets"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26.5"}]}],"title":"Alopecia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26.5"}]}],"title":"Neutrophils"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24.5"}]}],"title":"Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.4"}]}],"title":"Edema-limb"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.4"}]}],"title":"Hyponatremia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"description":"An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit.","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":"The Safety Population was used and defined as all treated participants. Participants who did not receive at least one dose of study medication were excluded from this population. For this study, the safety population is the same as the Intent to Treat (ITT) population.","reportingStatus":"POSTED","timeFrame":"From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months","title":"Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}