{"description":"One participant was enrolled and given induction chemotherapy but was never randomized to Arm TMS or AC. Subject had one AE (infection with normal ANC or Grade 1 or 2 neutrophils: Pharynx). Subject was taken off study for disease progression and died.","eventGroups":[{"deathsNumAffected":8,"deathsNumAtRisk":44,"description":"TMS Arm\n\nRituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease\n\nAllogenic stem cell transplant (ASCT): Allogenic stem cell transplant\n\nConditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3\n\nTMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.\n\nFLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy","id":"EG000","otherNumAffected":43,"otherNumAtRisk":44,"seriousNumAffected":36,"seriousNumAtRisk":44,"title":"A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm"},{"deathsNumAffected":19,"deathsNumAtRisk":45,"description":"AC Arm\n\nRituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease\n\nCyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop.\n\nAllogenic stem cell transplant (ASCT): Allogenic stem cell transplant\n\nConditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3\n\nFLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d","id":"EG001","otherNumAffected":42,"otherNumAtRisk":45,"seriousNumAffected":41,"seriousNumAtRisk":45,"title":"B - Cyclosporine (AC) Arm"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":44,"numEvents":75},{"groupId":"EG001","numAffected":17,"numAtRisk":45,"numEvents":45}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":44,"numEvents":73},{"groupId":"EG001","numAffected":23,"numAtRisk":45,"numEvents":50}],"term":"AST, SGOT(serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Acidosis (metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Adult Respiratory Distress Syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":44,"numEvents":15},{"groupId":"EG001","numAffected":12,"numAtRisk":45,"numEvents":23}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":20},{"groupId":"EG001","numAffected":6,"numAtRisk":45,"numEvents":9}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Alkalosis (metabolic or respiratory)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Allergic reaction/hypersensitivity (including drug fever)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Amylase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":4}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Bicarbonate, serum-low"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":44,"numEvents":22},{"groupId":"EG001","numAffected":16,"numAtRisk":45,"numEvents":38}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Bronchospasm, wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"CPK (creatine phosphokinase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Calcium, serum-high (hypercalcemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Calcium, serum-low (hypocalcemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":45,"numEvents":5}],"term":"Carbon monoxide diffusion capacity (DL(co))"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Cardiac General - Other (cardimyopathy)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Cardiac General - Other (heart failure, fluid overload)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Cardiac ischemia/infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":44,"numEvents":11},{"groupId":"EG001","numAffected":10,"numAtRisk":45,"numEvents":16}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Dermatology/Skin - Other (GVHD; cGVHD)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Dermatology/Skin - Other (MRSA abscess)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":44,"numEvents":25},{"groupId":"EG001","numAffected":22,"numAtRisk":45,"numEvents":32}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Dry eye syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Dry mouth/salivary gland (xerostomia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"Dysphagia (difficulty swallowing)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Edema: head and neck"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Edema: limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"FEV(1)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":45,"numEvents":5}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"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":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":9,"numAtRisk":45,"numEvents":9}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":9,"numAtRisk":45,"numEvents":12}],"term":"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Fibrinogen"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Fistula, GI::Anus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"GGT (gamma-Glutamyl transpeptidase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Gastritis (including bile reflux gastritis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Gastrointestinal - Other (GVHD)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(duodenal bx 1/24/11; very rare apoptotic cells CMV stains (-); steroids started for GVHD)","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Gastrointestinal - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Glucose, serum-high (hyperglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Heartburn/dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":44,"numEvents":108},{"groupId":"EG001","numAffected":26,"numAtRisk":45,"numEvents":150}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":4}],"term":"Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Hemorrhage, GI::Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Hemorrhage, GI::Anus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Hemorrhage, GI::Lower GI NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Hemorrhage, GU::Bladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemorrhage, GU::Urinary NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Hiccoughs (hiccups, singultus)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":45,"numEvents":7}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":4}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":8}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Induration/fibrosis (skin and subcutaneous tissue)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)::Abdomen NOS","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Infection ::Bladder (urinary)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":44,"numEvents":12},{"groupId":"EG001","numAffected":11,"numAtRisk":45,"numEvents":14}],"term":"Infection::Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection::Brain (encephalitis, infectious)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Brain + Spinal cord (encephalomyelitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection::Bronchus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection ::Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Infection ::Colon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection ::Eye NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Lip/perioral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":8},{"groupId":"EG001","numAffected":6,"numAtRisk":45,"numEvents":6}],"term":"Infection ::Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection::Oral cavity-gums (gingivitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)::","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection Sinus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection::Skin (cellulites)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection::Soft tissue NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Upper aerodigestive NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection:: Upper airway NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection::Urinary tract NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection - Other (CMV reactivation)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection - Other (Rhinovirus, Coronavirus HKU1)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection - Other (Varicella zoster; noravirus)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection - Other (acinetobacter)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection - Other (dissiminated HSV)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":5}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":44,"numEvents":44},{"groupId":"EG001","numAffected":25,"numAtRisk":45,"numEvents":62}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":3}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Colon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":8},{"groupId":"EG001","numAffected":12,"numAtRisk":45,"numEvents":18}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Nose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Penis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":5}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":6},{"groupId":"EG001","numAffected":9,"numAtRisk":45,"numEvents":10}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":3}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":44,"numEvents":14},{"groupId":"EG001","numAffected":9,"numAtRisk":45,"numEvents":10}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":45,"numEvents":6}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":4}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":3}],"term":"Infection with unknown ANC::Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with unknown ANC::Bronchus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with unknown ANC::Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with unknown ANC::Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with unknown ANC::Sinus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with unknown ANC::Skin (cellulites)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with unknown ANC::Upper aerodigestive NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Infection with unknown ANC::Upper airway NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with unknown ANC::Urinary tract NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with unknown ANC::Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Iron overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Joint-function"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":44,"numEvents":118},{"groupId":"EG001","numAffected":26,"numAtRisk":45,"numEvents":189}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Leukoencephalopathy (radiographic findings)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Lipase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Liver dysfunction/failure (clinical)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":44,"numEvents":143},{"groupId":"EG001","numAffected":27,"numAtRisk":45,"numEvents":181}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":44,"numEvents":22},{"groupId":"EG001","numAffected":16,"numAtRisk":45,"numEvents":26}],"term":"Magnesium, serum-high (hypermagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":9,"numAtRisk":45,"numEvents":15}],"term":"Magnesium, serum-low (hypomagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Mood alteration::Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Mood alteration::Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Mucositis/stomatitis (clinical exam)::Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Mucositis/stomatitis (functional/symptomatic)::Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":44,"numEvents":17},{"groupId":"EG001","numAffected":6,"numAtRisk":45,"numEvents":7}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Neurology - Other (delirium)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Neuropathy: motor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Neuropathy: sensory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":44,"numEvents":109},{"groupId":"EG001","numAffected":27,"numAtRisk":45,"numEvents":123}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Obstruction, GU::Bladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Ophthalmoplegia/diplopia (double vision)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Opportunistic infection associated with >=Grade 2 Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Osteonecrosis (avascular necrosis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":8,"numAtRisk":45,"numEvents":15}],"term":"PTT (Partial Thromboplastin Time)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pain::Anus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pain::Back"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Pain::Head/headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pain::Joint"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pain::Muscle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pain::Throat/pharynx/larynx"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pain::Urethra"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pancreatic endocrine: glucose intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Perforation, GI::Small bowel NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pericardial effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Phlebitis (including superficial thrombosis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":44,"numEvents":69},{"groupId":"EG001","numAffected":22,"numAtRisk":45,"numEvents":53}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":44,"numEvents":81},{"groupId":"EG001","numAffected":23,"numAtRisk":45,"numEvents":106}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Pleural effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":10,"numAtRisk":45,"numEvents":15}],"term":"Potassium, serum-high (hyperkalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44,"numEvents":16},{"groupId":"EG001","numAffected":17,"numAtRisk":45,"numEvents":36}],"term":"Potassium, serum-low (hypokalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Prolonged QTc interval"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Pruritus/itching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Psychosis (hallucinations/delusions)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Infiltrates; fungal pneumonia","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"Pulmonary/Upper Respiratory - Other (infiltrates)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pulmonary/Upper Respiratory - Other (infiltrates; fungal pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":44,"numEvents":30},{"groupId":"EG001","numAffected":26,"numAtRisk":45,"numEvents":39}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Rash: acne/acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Rash: hand-foot skin reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":4}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"dysuria; hematuria; stent replacement; fluid overload refractory to normal doses of Lasix","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Renal/Genitourinary - Other (acute renal injury)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Renal/Genitourinary - Other (dysuria)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Renal/Genitourinary - Other (dysuria; hematuria; stent replacement)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":45,"numEvents":7}],"term":"Renal/Genitourinary - Other (failure; hematuria; insufficiency; dysuria)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Renal/Genitourinary - Other (fluid overload refractory to normal doses of Lasix)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Renal/Genitourinary - Other (hematuria)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Renal/Genitourinary - Other (insufficiency)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Right ventricular dysfunction (cor pulmonale)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Secondary Malignancy - possibly related to cancer treatment (mucoepidermoid carcinoma)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma lip)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Skin breakdown/decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Sodium, serum-high (hypernatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":9},{"groupId":"EG001","numAffected":9,"numAtRisk":45,"numEvents":11}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia::Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia::Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Syncope (fainting)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Syndromes - Other (septic shock)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Taste alteration (dysgeusia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Thrombosis/embolism (vascular access-related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Thrombosis/thrombus/embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(e.g., thrombotic thrombocytopenic purpura \\[TTP\\] or hemolytic uremic syndrome \\[HUS\\])","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":4}],"term":"Thrombotic microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Thyroid function, low (hypothyroidism)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Triglyceride, serum-high (hypertriglyceridemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":7,"numAtRisk":45,"numEvents":16}],"term":"Uric acid, serum-high (hyperuricemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Urinary frequency/urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Urinary retention (including neurogenic bladder)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Vaginal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Vaginal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Wound complication, non-infectious"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"AST, SGOT(serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":45,"numEvents":6}],"term":"Adult Respiratory Distress Syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"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":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Allergic reaction/hypersensitivity (including drug fever)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Arthritis (non-septic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Ataxia (incoordination)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"CNS cerebrovascular ischemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Carbon monoxide diffusion capacity (DL(co))"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Cardiac ischemia/infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Cardiopulmonary arrest, cause unknown (non-fatal)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":8},{"groupId":"EG001","numAffected":7,"numAtRisk":45,"numEvents":12}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":3}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Cytokine release syndrome/acute infusion reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":7,"numAtRisk":45,"numEvents":7}],"term":"Death not associated with CTCAE term::Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":10,"numAtRisk":45,"numEvents":10}],"term":"Death not associated with CTCAE term::Disease progression NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Death not associated with CTCAE term::Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":9},{"groupId":"EG001","numAffected":8,"numAtRisk":45,"numEvents":10}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Dry eye syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Dysphagia (difficulty swallowing)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Edema: limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Edema: viscera"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"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":44,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":45,"numEvents":9}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Gastritis (including bile reflux gastritis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Heartburn/dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":4}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Hemorrhage, CNS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemorrhage, GI::Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemorrhage, GI::Duodenum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Hemorrhage, GI::Lower GI NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemorrhage, GI::Rectum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemorrhage, GI::Upper GI NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemorrhage, pulmonary/upper respiratory::Lung"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Hemorrhage, pulmonary/upper respiratory::Nose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":45,"numEvents":5}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":45,"numEvents":6}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":10},{"groupId":"EG001","numAffected":8,"numAtRisk":45,"numEvents":13}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)::","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection:: Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Bladder (urinary)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":8,"numAtRisk":45,"numEvents":10}],"term":"Infection ::Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":5}],"term":"Infection::Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Lip/perioral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":3}],"term":"Infection ::Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection::Meninges (meningitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Muscle (infection myositis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection::Nose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection::Rectum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Infection::Sinus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection ::Trachea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection::Upper airway NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection ::Urinary tract NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(S. Aureus positive blood; gram-neg-rod; line infection)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":3}],"term":"Infection - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":44,"numEvents":15},{"groupId":"EG001","numAffected":21,"numAtRisk":45,"numEvents":40}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":12,"numAtRisk":45,"numEvents":14}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Colon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Esophagus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Heart (endocarditis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Liver"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44,"numEvents":18},{"groupId":"EG001","numAffected":13,"numAtRisk":45,"numEvents":30}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Meninges (meningitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":2}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":45,"numEvents":8}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":5}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":45,"numEvents":4}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils::Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Infection with unknown ANC::Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with unknown ANC::Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Infection with unknown ANC::Colon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Infection with unknown ANC::Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Iron overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Left ventricular diastolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":4}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":4}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Leukoencephalopathy (radiographic findings)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Liver dysfunction/failure (clinical)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Magnesium, serum-low (hypomagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Mucositis/stomatitis (clinical exam)::Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Mucositis/stomatitis (functional/symptomatic)::Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Muscle weakness, generalized or specific area (not due to neuropathy)::Right-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(sclerodermic \\& fascial changes; leg cramping/edema possible GVHD, prednisone started)","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Musculoskeletal/Soft Tissue - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Myositis (inflammation/damage of muscle)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":3}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(idiopathic progressive retinal vasculitis; poss inflammatory process; uk etiology; total blindness)","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Ocular/Visual - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"PTT (Partial Thromboplastin Time)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pain::Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pain::Back"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pancreatic endocrine: glucose intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Perforation, GI::Small bowel NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pericardial effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":11}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Pleural effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":45,"numEvents":5}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Potassium, serum-high (hyperkalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Potassium, serum-low (hypokalemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Pulmonary/Upper Respiratory - Other (pleural thickening)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":7,"numAtRisk":45,"numEvents":10}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Rash: hand-foot skin reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44,"numEvents":12},{"groupId":"EG001","numAffected":6,"numAtRisk":45,"numEvents":10}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Renal/Genitourinary - Other (AKI, required CVVH)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Right ventricular dysfunction (cor pulmonale)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"possibly related to cancer treatment (PTLD(liver biopsy + 10/3/08, stomach bx 10/6/08), EBV associated; to cancer treatment (EBV associated PTLD, neck LN bx (+)10/12/11;to cancer treatment (EBV assoc. PTLD;tonsil bx 10/12/11;obstructing nasopharynx).","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":45,"numEvents":5}],"term":"Secondary Malignancy - possibly related to cancer treatment (AML);"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Somnolence/depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Stricture/stenosis (including anastomotic), GI::Esophagus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia::Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2}],"term":"Supraventricular and nodal arrhythmia::Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Supraventricular and nodal arrhythmia::Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Thrombosis/embolism (vascular access-related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Thrombosis/thrombus/embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(e.g., thrombotic thrombocytopenic purpura \\[TTP\\] or hemolytic uremic syndrome \\[HUS\\])","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Thrombotic microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Tumor lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0}],"term":"Ulcer, GI::Duodenum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Uric acid, serum-high (hyperuricemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Ventricular arrhythmia::Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":45,"numEvents":1}],"term":"Weight gain"}],"timeFrame":"103 months and 22 days"}