{"eventGroups":[{"description":"Induction Cycles 1-3: Methotrexate 8gm/m\\^2 days 1 \\& 15; Leucovorin 100 mg/m\\^2 days 2 \\& 16; Rituximab 375 mg/m\\^2 days 3, 10, 17 \\& 24 of cycle 1, days 3 \\& 10 of cycle 2; Temozolomide 150 mg/m\\^2/day PO days 7-11\n\nInduction Cycle 4: Temozolomide 150 mg/m\\^2/day PO days 7-11; Methotrexate 8gm/m\\^2 day 15; Leucovorin 100 mg/m\\^2 day 16\n\nConsolidation Cycle 5: Methotrexate 8gm/m\\^2 days 1; Leucovorin 100 mg/m\\^2 days 2; Temozolomide 150 mg/m\\^2/day PO days 7-11\n\nConsolidation Cycle 6: Cytarabine 2 g/m\\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\\^2/day starting day 14 until ANC recovers (\\>= 500 for 2 consecutive days or \\>= 1500 for one day)","id":"EG000","otherNumAffected":43,"otherNumAtRisk":44,"seriousNumAffected":15,"seriousNumAtRisk":44,"title":"Intensive Combination Chemo & Immunotherapy"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":7}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":44,"numEvents":90}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Atrial tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":4}],"term":"Cardiac disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":3}],"term":"Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Cushingoid"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":5}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Dry eye syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Eye disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Flashing vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":3}],"term":"Keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":16}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Watering eyes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":5}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":44,"numEvents":37}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":44,"numEvents":45}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":6}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":7}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":44,"numEvents":22}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":44,"numEvents":92}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Oral hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Typhlitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":44,"numEvents":44}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":7}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":44,"numEvents":36}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":44,"numEvents":83}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":9}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"General symptom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":3}],"term":"Localized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Bladder infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Gingival infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Infection with grade 3 or 4 neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Infectious colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Nail infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Opportunistic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Phlebitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Upper aerodigestive tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":3}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Vascular access complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":44,"numEvents":85}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":11}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":44,"numEvents":81}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":44,"numEvents":32}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":44,"numEvents":32}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2}],"term":"Fibrinogen decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":7}],"term":"Laboratory test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":44,"numEvents":39}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":7}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":44,"numEvents":59}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":44,"numEvents":52}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Serum cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":44,"numEvents":43}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":44,"numEvents":53}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":6}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":5}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":44,"numEvents":41}],"term":"Serum albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":44,"numEvents":32}],"term":"Serum calcium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":5}],"term":"Serum glucose decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":13}],"term":"Serum magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":4}],"term":"Serum magnesium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":9}],"term":"Serum phosphate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":44,"numEvents":68}],"term":"Serum potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":3}],"term":"Serum potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":44,"numEvents":32}],"term":"Serum sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":8}],"term":"Serum sodium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":9}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":13}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":4}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":6}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":4}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":44,"numEvents":19}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44,"numEvents":11}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":10}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":6}],"term":"Facial nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":44,"numEvents":47}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":12}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Mini mental status examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Neurological disorder NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2}],"term":"Nystagmus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":17}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":44,"numEvents":21}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Speech disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":6}],"term":"Trigeminal nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":44,"numEvents":20}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":44,"numEvents":19}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":16}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":44,"numEvents":25}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Psychosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Bladder spasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Glomerular filtration rate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Hemorrhage urinary tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":5}],"term":"Urogenital disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Vaginal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":7}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":44,"numEvents":19}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":7}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Laryngeal edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":5}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Respiratory disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":9}],"term":"Voice alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":7}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":44,"numEvents":27}],"term":"Rash desquamating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Skin disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Hot flashes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":13}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":5}],"term":"Thrombosis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":44,"numEvents":13}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Cardiopulmonary arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Conduction disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Ear, nose and throat examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":7}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Rectal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Small intestinal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Upper gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":44,"numEvents":5}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Facial pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":7}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Localized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Anorectal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Lymph gland infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Opportunistic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Peritoneal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Rhinitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":44,"numEvents":10}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":3}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":8}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Laboratory test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":44,"numEvents":10}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44,"numEvents":10}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Serum cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":44,"numEvents":10}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6}],"term":"Serum albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":44,"numEvents":6}],"term":"Serum calcium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4}],"term":"Serum magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Serum magnesium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Serum phosphate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":44,"numEvents":7}],"term":"Serum potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Serum potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Serum sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Serum sodium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Muscle weakness right-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Musculoskeletal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":4}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":5}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Mini mental status examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Neurological disorder NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Nystagmus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":2}],"term":"Speech disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":5}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":44,"numEvents":2}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Respiratory disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":44,"numEvents":3}],"term":"Rash desquamating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":44,"numEvents":4}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":44,"numEvents":1}],"term":"Vascular disorder"}]}