{"description":"Graft versus Host Disease (GVHD) and other toxicity was graded per NCI's common terminology criteria for adverse events (CTCAE) (3.0).","eventGroups":[{"description":"Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \\> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.","id":"EG000","otherNumAffected":77,"otherNumAtRisk":80,"seriousNumAffected":16,"seriousNumAtRisk":80,"title":"Cohort A - Lymphoid Disease"},{"description":"Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \\> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.","id":"EG001","otherNumAffected":52,"otherNumAtRisk":57,"seriousNumAffected":10,"seriousNumAtRisk":57,"title":"Cohort B - Myeloid Disease"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":80,"numEvents":3},{"groupId":"EG001","numAffected":13,"numAtRisk":57,"numEvents":13}],"term":"Failure to Engraft"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":80,"numEvents":20},{"groupId":"EG001","numAffected":4,"numAtRisk":57,"numEvents":4}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Fever without neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":57,"numEvents":5}],"term":"Rash/desquamation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":57,"numEvents":2}],"term":"Mucositis/Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":57,"numEvents":2}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Liver laceration; Retroperitoneal bleed; Ulcerative Colitis; Death (4)","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":57,"numEvents":3}],"term":"Hemorrhage/Bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":80,"numEvents":46},{"groupId":"EG001","numAffected":22,"numAtRisk":57,"numEvents":23}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Pneumonia; Sepsis; Viremia; Human Herpes Virus 6; Herpes Simplex Virus; Cytomegalovirus; Fungal Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":80,"numEvents":14},{"groupId":"EG001","numAffected":4,"numAtRisk":57,"numEvents":5}],"term":"Infection - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Bacteremia; Polyoma; Cytomegalovirus; Viremia; Varicella Zoster; Human Herpes Virus 6; Parainfluenza; Respiratory syncytial virus; Penicillium; Vancomycin-resistant enterococcus; Nocardia; Strep Viridans; Gram+ cocci; Ecoli; C-Diff; Klebsiella; MRSA","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":80,"numEvents":118},{"groupId":"EG001","numAffected":41,"numAtRisk":57,"numEvents":90}],"term":"Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Varicella Zoster; Cytomegalovirus; Viremia; Pneumonia; Stenotrophomonas Maltophilin; Herpes Simplex Virus; Human Herpes Virus 6; Gram+ cocci; Polyoma; Respiratory syncytial virus; C-Diff; Rhizopus; Parainfluenza; BK virus; Staph; MRSA; Gram- rod","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":80,"numEvents":101},{"groupId":"EG001","numAffected":18,"numAtRisk":57,"numEvents":37}],"term":"Infection with normal ANC or grade 1 or 2 neutrophils"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Thrush; Polyoma; Gram negative Sepsis; Gram positive cocci; Cytomegalovirus; Human Herpes Virus 6; Parainfluenza","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":1}],"term":"Infection with unknown ANC"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":80,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":1}],"term":"Creatinine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Shortness of Breath","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":80,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":7},{"groupId":"EG001","numAffected":5,"numAtRisk":57,"numEvents":5}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Polyoma nephritis; Dysuria; Foscarnet urethritis; Hematuria; Renal Insufficiency; Renal Failure (3)","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":80,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":57,"numEvents":3}],"term":"Renal/Genitourinary - Other"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":80,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":1}],"term":"Cardiac Ischemia/Infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":80,"numEvents":9},{"groupId":"EG001","numAffected":6,"numAtRisk":57,"numEvents":6}],"term":"Death - NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Elevation bilirubin and alkaline phosphate","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Hepatobiliary/Pancreas"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Meningitis; Parainfluenza; Herpes Zoster; Nocardia; Sepsis; Hickman line infection; C-Diff","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":80,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":57,"numEvents":3}],"term":"Infection - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Sepsis; Parainfluenza III; Gram positive cocci (Staph Aureus); Human Herpes Virus 6; Pneumonia; Polyoma virus; Viremia","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":57,"numEvents":5}],"term":"Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"H. pylori; BK virus; Influenza","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Infection with grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Fever possibly due to Human Herpes Virus 6","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Infection with unknown ANC"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":2}],"term":"Altered Mental Status"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Death","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Adult Respiratory Distress Syndrome (ARDS)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Shortness of Breath","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":80,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":1}],"term":"CNS - Cerebrovascular Ischemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":1}],"term":"Renal Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":57,"numEvents":0}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Central Nervous System","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":80,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":1}],"term":"Hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Portal hypertension","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":80,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":57,"numEvents":1}],"term":"Liver dysfunction/failure"}],"timeFrame":"Participants will be evaluated at a minimum of 2 times per week by physical exam for toxicity following Version 3 of the NCI expanded common toxicity criteria through day 45 following the first infusion."}