{"eventGroups":[{"description":"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.\n\nVAD: 3 Cycles (3rd cycle optional):\n\nVincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20\n\nHigh-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:\n\nCytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1\n\nHemopoietic stem cell procurement: Collection target = 10 x 10\\^6 cells/kg\n\nEDAP: Approximately 5-6 weeks after high-dose cyclophosphamide","id":"EG000","otherNumAffected":231,"otherNumAtRisk":231,"seriousNumAffected":231,"seriousNumAtRisk":231,"title":"Study Treatment"}],"frequencyThreshold":"5","otherEvents":[{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":231}],"term":"Anemia grade 2"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":231}],"term":"Thrombocyt grade 2"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":231}],"term":"Hepatobiliary/ pancreas grade 1"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":138,"numAtRisk":231}],"term":"Hepatobiliary/pancreas grade 2"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":231}],"term":"Alkaline grade 1"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":231}],"term":"Alkaline grade 2"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":231}],"term":"Bilirubin grade 1"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":231}],"term":"Bilirubin grade 2"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":231}],"term":"Hypoalbumi grade 1"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":150,"numAtRisk":231}],"term":"Hypoalbumi grade 2"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":78,"numAtRisk":231}],"term":"SGOT (AST) grade 1"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":231}],"term":"SGOT (AST) grade 2"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":231}],"term":"SGPT (ALT) grade 1"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":231}],"term":"SGPT (ALT) grade 2"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":231}],"term":"Metabolic/laboratory grade 2"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":97,"numAtRisk":231}],"term":"Bicarbonat grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":231}],"term":"Hypercalce grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":231}],"term":"Hyperglyce grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":231}],"term":"Hyperglyce grade 2"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":231}],"term":"Hyperkalem grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":231}],"term":"Hyperkalem grade 2"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":231}],"term":"Hypemagne grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":231}],"term":"Hypematre grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":231}],"term":"Hypocalcem grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":231}],"term":"Hypocalcem grade 2"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":105,"numAtRisk":231}],"term":"Hypokalemi grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":116,"numAtRisk":231}],"term":"Hypomagnes grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":231}],"term":"Hypomagnes grade 2"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":97,"numAtRisk":231}],"term":"Hyponatrem grade 1"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":231}],"term":"Hypophosph grade 2"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":231}],"term":"Renal/genitourinary grade 1"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":231}],"term":"Renal/genitourinary grade 2"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":231}],"term":"Creatinine grade 1"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":231}],"term":"Creatinine grade 2"}],"seriousEvents":[{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":155,"numAtRisk":231}],"term":"Blood/bone marrow Grade 4"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":231}],"term":"Anemia Grade 4"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":231}],"term":"Neutropeni Grade 4"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":150,"numAtRisk":231}],"term":"WBC Grade 4"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":231}],"term":"Thrombocyt Grade 4"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":231}],"term":"Hepatobiliary/pancreas grade 3"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":231}],"term":"Hepatobiliary/pancreas grade 4"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":231}],"term":"Alkaline grade 3"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":231}],"term":"Bilirubin grade 3"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":231}],"term":"Bilirubin grade 4"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":231}],"term":"Hypoalbumi grade 3"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":231}],"term":"SGOT (AST) grade 3"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":231}],"term":"SGPT (ALT) grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":89,"numAtRisk":231}],"term":"Metabolic/laboratory grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":231}],"term":"Metabolic/laboratory grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":231}],"term":"Bicarbonat grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":231}],"term":"Hypercalce grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":231}],"term":"Hypercalce grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":231}],"term":"Hyperglyce grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":231}],"term":"Hyperglyce grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":231}],"term":"Hyperkalem grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":231}],"term":"Hyperkalem grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":231}],"term":"Hypermagne grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":231}],"term":"Hypematre grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":231}],"term":"Hypematre grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":231}],"term":"Hypocalcem grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":231}],"term":"Hypocalcem grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":231}],"term":"Hypokalemi grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":231}],"term":"Hypokalemi grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":231}],"term":"Hypomagnes grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":231}],"term":"Hypomagnes grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":231}],"term":"Hyponatrem grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":231}],"term":"Hyponatrem grade 4"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":83,"numAtRisk":231}],"term":"Hypophosph grade 3"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":231}],"term":"Hypophosph grade 4"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":231}],"term":"Renal/Genitourinary grade 3"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":231}],"term":"Renal/Genitourinary grade 4"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":231}],"term":"Creatinine grade 3"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":231}],"term":"Creatinine grade 4"}]}