{"description":"Treatment-emergent adverse events and serious adverse events were reported. Safety population included all treated participants. Participants who did not receive at least 1 dose of study treatment were excluded from this population. All toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.","eventGroups":[{"deathsNumAffected":18,"deathsNumAtRisk":49,"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":"EG000","otherNumAffected":49,"otherNumAtRisk":49,"seriousNumAffected":25,"seriousNumAtRisk":49,"title":"Denileukin Diftitox in Combination With CHOP"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":49}],"term":"Edema-limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":49}],"term":"ALT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTC 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3.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":49}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49}],"term":"Ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":49}],"term":"AST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":49}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":49}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":49}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":49}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":49}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":49}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTC 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3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":49}],"term":"Taste alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":49}],"term":"Neuro Pain: head/headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Vaginitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49}],"term":"Thrombosis/embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system 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Pain: cardiac/heart"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Left vent. diastolic function"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49}],"term":"Mood alterations: depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49}],"term":"Skin Inf., 0-2 ANC: skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Neurop: hear & bal."},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":49}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Edema-trunk/genital"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTC 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49}],"term":"Musculo. 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