{"eventGroups":[{"description":"Fludarabine 30 mg/m\\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).\n\nMelphalan 140 mg/m\\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\\^2 IV infused starting on day -5.","id":"EG000","otherNumAffected":8,"otherNumAtRisk":27,"seriousNumAffected":23,"seriousNumAtRisk":27,"title":"Fludarabine + Melphalan + Stem Cell Infusion"},{"description":"Fludarabine 30 mg/m\\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).\n\nLower-Dose Melphalan 100 mg/m\\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\\^2 IV infused starting on day -5.","id":"EG001","otherNumAffected":10,"otherNumAtRisk":23,"seriousNumAffected":16,"seriousNumAtRisk":23,"title":"Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":23,"numEvents":3}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":23,"numEvents":3}],"term":"Volume overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":23,"numEvents":6}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":23,"numEvents":5}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":27,"numEvents":8},{"groupId":"EG001","numAffected":10,"numAtRisk":23,"numEvents":11}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":23,"numEvents":3}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Elevated Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":23,"numEvents":2}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":23,"numEvents":3}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Dysarrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":23,"numEvents":2}],"term":"Elevated Alkaline Phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":23,"numEvents":2}],"term":"Elevated ALT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Neuropathy"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":27,"numEvents":23},{"groupId":"EG001","numAffected":16,"numAtRisk":23,"numEvents":16}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":23,"numEvents":14}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Seizures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Total Bilirubin Level Change"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Secondary graft failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Altered mental status"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"Elevated creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Pulmonary hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Elevated ALT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"Dysphagia"}],"timeFrame":"The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013."}