{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Allergy/Immunology: Allergic reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.2"}]}],"title":"Blood/Bone Marrow: Hemoglobin"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16.3"}]}],"title":"Blood/Bone Marrow: Leukocytes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24.5"}]}],"title":"Blood/Bone Marrow: Lymphopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16.3"}]}],"title":"Blood/Bone Marrow: Neutrophils"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12.2"}]}],"title":"Blood/Bone Marrow: Platelets"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Cardiac Arrhythmia: Supra Arrhyth:Sinus Tachy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Cardiac General: Cardiac ischemia/infarction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Cardiac General: Cardiopulmonary arrest"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Coagulation: Coagulation-other"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Constitutional symptoms: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Constitutional symptoms: Fever"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Death: Death, NOS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10.2"}]}],"title":"Infection: Febrile neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Infection: Inf, 3-4 ANC: cath-related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Infection: Infection-other"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Infection: Lung Inf, 0-2 ANC: lung"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Metabolic/Laboratory: Alanine transaminase (ALT)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Metabolic/Laboratory: Aspartate transaminase (AST)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Metabolic/Laboratory: CPK"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Metabolic/Laboratory: Cholesterol"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Metabolic/Laboratory: GGT"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Metabolic/Laboratory: Hypoalbuminemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Metabolic/Laboratory: Hypokalemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Pain: Pain-other"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Pulmonary/Upper Respiratory: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Pulmonary/Upper Respiratory: Hypoxia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Pulmonary/Upper Respiratory: Pneumonitis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0"}]}],"title":"Syndromes: Tumor Lysis syndrome"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"}]}],"title":"Vascular: Thrombosis/embolism"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"description":"Treatment-related AEs were medical occurrences determined to be possibly, probably, or definitely related to study treatment. Severity grading of the AE was according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) severity scale (grades 1 - 5) with grade 3 representing a severe AE. 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":"Safety 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 Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}