{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":18,"description":"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.\n\nFludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.\n\nCyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.\n\nYoung TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).\n\nAldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).","id":"EG000","otherNumAffected":17,"otherNumAtRisk":18,"seriousNumAffected":4,"seriousNumAtRisk":18,"title":"Cervical"},{"deathsNumAffected":0,"deathsNumAtRisk":11,"description":"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin\n\nFludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.\n\nCyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.\n\nYoung TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).\n\nAldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).","id":"EG001","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":2,"seriousNumAtRisk":11,"title":"NonCervical"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":18,"numEvents":16},{"groupId":"EG001","numAffected":8,"numAtRisk":11,"numEvents":8}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":18,"numEvents":10},{"groupId":"EG001","numAffected":8,"numAtRisk":11,"numEvents":8}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":18,"numEvents":18},{"groupId":"EG001","numAffected":10,"numAtRisk":11,"numEvents":10}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":18,"numEvents":17},{"groupId":"EG001","numAffected":11,"numAtRisk":11,"numEvents":11}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":18,"numEvents":17},{"groupId":"EG001","numAffected":11,"numAtRisk":11,"numEvents":11}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hemorrhage, GI:: Lower GI NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hemorrhage, GU::Urinary NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(fever of unknown origin without clinically or microbiologically documented infection)(ANC \\<1.0 x 10e9/L, fever \\>=38.5 degrees C)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)::Blood","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18,"numEvents":6},{"groupId":"EG001","numAffected":6,"numAtRisk":11,"numEvents":6}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Potassium, serum-low (hypokalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Muscle weakness, generalized or specific area (not due to neuropathy)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Psychosis (hallucinations/delusions)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Syncope (fainting)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pain::Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18,"numEvents":7},{"groupId":"EG001","numAffected":5,"numAtRisk":11,"numEvents":5}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pleural effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Renal/Genitourinary - Other (Oliguria)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Incontinence, anal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Mental status"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hemorrhage, GI::Rectum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hemorrhage, GU::Vagina"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)::Upper airway NOS","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Infection (documented clinically or microbiologically)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(ANC \\<1.0 x 10e9/L)::Urinary tract NOS","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pain::Back"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pain::Chest wall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pain::Joint"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Obstruction, GU::Ureter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pain::Head/Headache"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Death not associated with CTCAE term: Disease progression NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(fever of unknown origin without clinically or microbiologically documented infection)(ANC \\<1.0 x 10e9/L, fever \\>=38.5 degrees C)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(ANC \\<1.0 x 10e) ::Blood","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)::Oral cavity-gums (gingivitis)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Obstruction, GU::Ureter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Dysphagia (difficulty swallowing)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Syncope (fainting)"}],"timeFrame":"51 months and 18 days"}