{"eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":39,"description":"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:\n\nTRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.\n\nMAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant","id":"EG000","otherNumAffected":32,"otherNumAtRisk":39,"seriousNumAffected":14,"seriousNumAtRisk":39,"title":"Treatment (10 mg Lenalidomide)"},{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:\n\nTRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.\n\nMAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant","id":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Treatment (15 mg Lenalidomide)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":39},{"groupId":"EG001","numAffected":4,"numAtRisk":4}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":39},{"groupId":"EG001","numAffected":3,"numAtRisk":4}],"term":"White blood cell decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 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decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":39},{"groupId":"EG001","numAffected":3,"numAtRisk":4}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":39},{"groupId":"EG001","numAffected":2,"numAtRisk":4}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":39},{"groupId":"EG001","numAffected":2,"numAtRisk":4}],"term":"diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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(4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":39},{"groupId":"EG001","numAffected":3,"numAtRisk":4}],"term":"cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"infections and infestation, Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"general disorders -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":39},{"groupId":"EG001","numAffected":2,"numAtRisk":4}],"term":"pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"Other blood and lymphatic disorders"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"dry eye"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":39},{"groupId":"EG001","numAffected":0,"numAtRisk":4}],"term":"dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 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impaired"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"ACUTE ENCEPHALOPATHY"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":39},{"groupId":"EG001","numAffected":1,"numAtRisk":4}],"term":"vomiting"}],"timeFrame":"Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)"}