{"description":"Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the \"AE Other\" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.","eventGroups":[{"deathsNumAffected":8,"deathsNumAtRisk":20,"description":"Patients receive erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.","id":"EG000","otherNumAffected":19,"otherNumAtRisk":20,"seriousNumAffected":10,"seriousNumAtRisk":20,"title":"Treatment (Erdafitinib)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":20}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":20}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Mucositis/stomatitis (functional/symptomatic) - Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Generalized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypothermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Nail infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":20}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":20}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Blood bicarbonate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"GGT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Thyroid stimulating hormone increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":20}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Metabolism and nutrition disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Scoliosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypersomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Muscle weakness left-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Renal calculi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Reproductive system and breast disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":20}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Nail changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Nail discoloration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Nail loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Nail ridging"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Kyphosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Lordosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Scoliosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20}],"term":"Vascular disorders - Other, specify"}],"timeFrame":"Up to 2 years from study entry."}