{"description":"Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":15,"description":"PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.","id":"EG000","otherNumAffected":11,"otherNumAtRisk":15,"seriousNumAffected":9,"seriousNumAtRisk":15,"title":"Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Chest pain - cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":15}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":15}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":15}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Mucositis, oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":15}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Stomach pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":15}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":15}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Edema trunk"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":15}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":15}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Coag negative staph infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"CMV reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Upper respiratory infection - Rhinovirus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Upper respiratory infection - Rhinorrea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Upper respiratory infection - Metapneumovirus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":15}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":15}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":15}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Muscle weakness, lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Muscle weakness, trunk"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":15}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":15}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hallucinations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":15}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Postnasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Sinus disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Pruritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":15}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":15}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE) Version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15}],"term":"Hypertension"}],"timeFrame":"Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician."}