{"eventGroups":[{"deathsNumAffected":21,"deathsNumAtRisk":63,"description":"Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \\[ie, autologous hematopoietic cells transplant (Auto-HCT)\\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \\& Day 0, to a target of \\> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \\& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.","id":"EG000","otherNumAffected":63,"otherNumAtRisk":63,"seriousNumAffected":63,"seriousNumAtRisk":63,"title":"All Participants Receviing at Least Auto-HCT"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Acute Kidney Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Clostridium Difficile Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":63,"numEvents":6}],"term":"Cytomegalovirus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Coagulase-negative staphylococci"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Dehyration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Disseminated varicella zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":63,"numEvents":5}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Gastritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Herpes Zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":63,"numEvents":6}],"term":"Maculo-papular rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":63,"numEvents":6}],"term":"Mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":63,"numEvents":7}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":63,"numEvents":17}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Parainfluenza pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":63,"numEvents":15}],"term":"Platelet count decrease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":63,"numEvents":16}],"term":"Renal Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Seborrheic dermatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Steroid Myopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Transaminitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Thrombotic Thrombocytopenic Purpura"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Viral bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Viral Pneumonitis"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Lung Aspergillosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":63,"numEvents":3}],"term":"Pulmonary Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Heart Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Cardiopulmonary Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Acute Kidney Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Aseptic Encephalitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Cytomegalovirus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":63,"numEvents":3}],"term":"Coagulase-negative staphylococci"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":63,"numEvents":4}],"term":"Disseminated varicella zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Erosive esophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":63,"numEvents":31}],"term":"Febrile Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":63,"numEvents":3}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Fungemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":63,"numEvents":6}],"term":"Gram-negative bacillary bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 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(4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":63,"numEvents":8}],"term":"Mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Myopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":63,"numEvents":4}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":63,"numEvents":4}],"term":"Platelet count decrease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":63,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Pseudomonas bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Renal Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Rhabdomyositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Right Parietal Encephalocele"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":63,"numEvents":5}],"term":"Respiratory syncytial virus pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Supraventricular tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Superior Vena Cava Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":63,"numEvents":1}],"term":"Viral Pneumonitis"}],"timeFrame":"3 years"}