{"description":"Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. 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mg/kg)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":20}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Heart murmur"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Chest pain - cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":20}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":20}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Abnormal satiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":20}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Typhlitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 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4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Systemic inflammatory response syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Bronchial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Swollen ankle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":20}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":20}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":20}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":20}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":20}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Serum amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":20}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition 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4.03","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":20}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 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and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":20}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Elevated liver enzymes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Drug-induced liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hepatic steatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Benign paroxysmal positional vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Difficulty with fine motor skills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Restless leg syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Increase urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Malodorous urine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Low glomerular filtration rate"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Renal tubulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Catheter associated urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Polyp underneath eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Platelet count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Abnormal Blood Urea Nitrogen"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Increased Lactate Dehydrogenase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Decreased monocytes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Generalized body soreness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Tendonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Muscle twinges in legs, abdomen, and chest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Left shoulder pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypovolemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Low iron"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Lactic Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Mouth sores"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Worsening of right lung opacity in CT scan"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Shortness of breath with exertion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Itching of medial portion of the knees"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"tender back"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"redness of left leg"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Cellulitis behind ear"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 patient also experienced dyspena and chest pain at the time of this event.\n\n1 patient also experienced upper respiratory infection at the time of this event.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 patient also experienced fever at the time of this event.","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 patient also experienced chills and malaise at the time of this event.","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 patient also experienced a decrease in neutrophil count at the time of this event.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"This patient also experienced hyperglycemia, pneumonia, drug-induced liver injury, and catheter-associated urinary tract infection at the time of this event.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Typhlitis"}],"timeFrame":"Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance)."}