{"eventGroups":[{"deathsNumAffected":6,"deathsNumAtRisk":11,"description":"Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m\\^2 (cumulative total dose of 1250 mg/m\\^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.","id":"EG000","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":6,"seriousNumAtRisk":11,"title":"DRBEAT Regimen"}],"frequencyThreshold":"05","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 351 mg/m\\^2","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 351 mg/m\\^2","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 734 mg/m\\^2","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 379 mg/m\\^2, 521 mg/m\\^2, 611 mg/m\\^2, 734 mg/m\\^2, and 762 mg/m\\^2","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":5}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 351 mg/m\\^2","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 440 mg/m\\^2","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Blood and lymphatic disorders -Other, specify: Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 351 mg/m\\^2","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 379 mg/m\\^2","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Facial muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2 and 431 mg/m\\^2","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2 -1 participant, 287 mg/m\\^2 -1 participant, 351 mg/m\\^2 -1 participant (2 events), 379 mg/m\\^2 -1 participant (2 events), 431 mg/m\\^2 -1 participant, 521 mg/m\\^2 -1 participant, 611 mg/m\\^2 -1 participant, 693 mg/m\\^2 -1 participant","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":11,"numEvents":11}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 734 mg/m\\^2","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hypertryglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 440 mg/m\\^2","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2 and 287 mg/m\\^2","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 762 mg/m\\^2","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Infections and infestations -Other, specify: Ecoli bacteria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 521 mg/m\\^2","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 762 mg/m\\^2","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2 -1 participant, 287 mg/m\\^2 -1 participant (2 events), and 431 mg/m\\^2 -1 participant (2 events)","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":5}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 762 mg/m\\^2","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 379 mg/m\\^2","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Musculoskeletal and connective tissue disorders -Other, specify: Neck weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2 -1 participant, 351 mg/m\\^2 -1 participant (2 events), and 693 mg/m\\^2 -1 participant","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":5}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2 -1 participant, 287 mg/m\\^2 -1 participant, 351 mg/m\\^2 -1 participant, 379 mg/m\\^2 -1 participant, 431 mg/m\\^2 -1 participant, 521 mg/m\\^2 -1 participant, 611 mg/m\\^2 -1 participant, 693 mg/m\\^2, 734 mg/m\\^2 -1 participant (2 events)","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":11,"numEvents":10}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 693 mg/m\\^2","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 379 mg/m\\^2","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 431 mg/m\\^2","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 287 mg/m\\^2 -1 participant, 351 mg/m\\^2 -1 participant (3 events), and 611 mg/m\\^2 -1 participant","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":5}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2 -1 participant, 287 mg/m\\^2 -1 participant, 351 mg/m\\^2 -1 participant (4 events), 431 mg/m\\^2 -1 participant, and 762 mg/m\\^2 -1 participant (2 events)","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":9}],"term":"White blood cell decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 431 mg/m\\^2","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 351 mg/m\\^2","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 431 mg/m\\^2","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Gait disturbances"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 250 mg/m\\^2","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Renal and Urinary disorders -Other, specify: High squamous epithelial cells"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Temozolomide 379 mg/m\\^2, 611 mg/m\\^2, and 762 mg/m\\^2","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Sepsis"}],"timeFrame":"Over a two year period, from start of research therapy to 2 years post treatment."}