{"eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":4,"description":"Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\ncyclophosphamide: Given IV\n\ndoxorubicin hydrochloride: Given IV\n\nvincristine sulfate: Given IV\n\nprednisone: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"EG000","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":4,"seriousNumAtRisk":4,"title":"Arm I (CHOP)"},{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nlomustine: Given PO\n\netoposide: Given PO\n\ncyclophosphamide: Given PO\n\nprocarbazine hydrochloride: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Arm II (Oral Chemotherapy)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Blood and lymphatic system disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Tinnitus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Otitis externa"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":3}],"term":"Alkaline phosphatase"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"GGT increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"White blood cell decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Hypernatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Hyperuricemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":3}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Facial nerve disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Nail coloration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Skin hyperpigmentation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":3}],"term":"Neoplasms, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Encephalitis infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3}],"term":"Death cause unknown"}],"timeFrame":"2 years"}