{"description":"\"Other Adverse Events\" include all events that were not severe adverse events regardless of grade or relation to treatment.","eventGroups":[{"description":"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nbevacizumab: Given IV\n\ncyclophosphamide: Given PO","id":"EG000","otherNumAffected":70,"otherNumAtRisk":70,"seriousNumAffected":23,"seriousNumAtRisk":70,"title":"Treatment (Bevacizumab, Cyclophosphamide)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Blood disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":70,"numEvents":105}],"term":"Hemoglobin decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":3}],"term":"Lymphatic disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Myocardial ischemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":5}],"term":"Palpitations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":16}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":6}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":3}],"term":"Ear pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"External ear inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":24}],"term":"Hearing loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":18}],"term":"Hearing test abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":58}],"term":"Tinnitus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Cataract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":4}],"term":"Dry eye syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Eye pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":11}],"term":"Flashing vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":8}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":70,"numEvents":47}],"term":"Abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":70,"numEvents":142}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Colonic perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":70,"numEvents":129}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":70,"numEvents":99}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":16}],"term":"Dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":70,"numEvents":80}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Ear, nose and throat examination abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":12}],"term":"Esophageal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":5}],"term":"Esophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Fecal incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":70,"numEvents":12}],"term":"Flatulence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":5}],"term":"Gastritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":70,"numEvents":31}],"term":"Gastrointestinal disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Gastrointestinal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Gingival pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Hemorrhoidal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":70,"numEvents":48}],"term":"Hemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Ileus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Lip pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":4}],"term":"Malabsorption"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":70,"numEvents":38}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":70,"numEvents":115}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":21}],"term":"Oral hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Oral pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":13}],"term":"Periodontal disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Rectal fistula"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":8}],"term":"Rectal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":3}],"term":"Stomach pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":70,"numEvents":26}],"term":"Tooth disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Toothache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":70,"numEvents":57}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":15}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":70,"numEvents":11}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":70,"numEvents":41}],"term":"Disease progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":70,"numEvents":33}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":70,"numEvents":408}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":70,"numEvents":10}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":6}],"term":"Flu-like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":5}],"term":"General symptom"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Injection site reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Localized edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":70,"numEvents":36}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":21}],"term":"Bladder infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Conjunctivitis infective"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":70,"numEvents":9}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Infectious colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Lip infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":8}],"term":"Opportunistic infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":4}],"term":"Phlebitis infective"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":7}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":4}],"term":"Rhinitis infective"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":5}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":12}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Vaginal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Vulvitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":6}],"term":"Bruising"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":7}],"term":"Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Radiation recall reaction (dermatologic)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Vascular access complication"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":3}],"term":"Wound dehiscence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":70,"numEvents":41}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":70,"numEvents":109}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":70,"numEvents":97}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Amylase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":70,"numEvents":62}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Coagulopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Creatine phosphokinase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":70,"numEvents":162}],"term":"Creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Haptoglobin decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":6}],"term":"Hyperbilirubinemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Hypercholesterolemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":6}],"term":"INR increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Laboratory test abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":70,"numEvents":114}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":70,"numEvents":351}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":70,"numEvents":40}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":70,"numEvents":65}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Serum cholesterol increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Weight gain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":70,"numEvents":44}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":70,"numEvents":73}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Blood bicarbonate decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":19}],"term":"Glucose intolerance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":70,"numEvents":27}],"term":"Hypercalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":70,"numEvents":53}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":16}],"term":"Hyperkalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Hypermagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":70,"numEvents":10}],"term":"Hypernatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Hypertriglyceridemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":10}],"term":"Hyperuricemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":70,"numEvents":24}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":70,"numEvents":12}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Hypoglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":70,"numEvents":27}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":70,"numEvents":165}],"term":"Hypomagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":70,"numEvents":62}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":70,"numEvents":8}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":4}],"term":"Serum calcium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":3}],"term":"Serum magnesium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":4}],"term":"Serum sodium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":6}],"term":"Serum triglycerides increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":70,"numEvents":74}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":70,"numEvents":82}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":5}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Chest wall pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Joint disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":70,"numEvents":182}],"term":"Joint pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Muscle weakness lower limb"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":3}],"term":"Musculoskeletal disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":70,"numEvents":73}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":14}],"term":"Neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":17}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":15}],"term":"Tumor flare"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":70,"numEvents":27}],"term":"Tumor pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":70,"numEvents":38}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":4}],"term":"Extrapyramidal disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":70,"numEvents":234}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Ischemia cerebrovascular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":5}],"term":"Memory impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Neurological disorder NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Olfactory nerve disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":70,"numEvents":127}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":6}],"term":"Sinus pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Speech disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":70,"numEvents":30}],"term":"Taste alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":70,"numEvents":124}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":6}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":70,"numEvents":62}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":70,"numEvents":145}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":5}],"term":"Bladder pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":5}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":3}],"term":"Hemoglobinuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":70,"numEvents":38}],"term":"Hemorrhage urinary tract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":31}],"term":"Kidney pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":13}],"term":"Protein urine positive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":70,"numEvents":137}],"term":"Proteinuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":6}],"term":"Ureteric obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Urethral hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":14}],"term":"Urethral pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":9}],"term":"Urinary frequency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":12}],"term":"Urinary incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Urine discoloration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Urogenital disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Breast pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":8}],"term":"Pelvic pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Vaginal discharge"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":4}],"term":"Vaginal dryness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Vaginal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Vaginal inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":3}],"term":"Vaginal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":70,"numEvents":57}],"term":"Allergic rhinitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Bronchial fistula"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":70,"numEvents":45}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":70,"numEvents":112}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":70,"numEvents":23}],"term":"Hemorrhage nasal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2}],"term":"Laryngeal mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Pharyngeal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Pharyngeal mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":70,"numEvents":13}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":3}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Respiratory disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Respiratory tract hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":70,"numEvents":22}],"term":"Voice alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":70,"numEvents":115}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Decubitus ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":70,"numEvents":23}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Erythema multiforme"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":17}],"term":"Nail disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":13}],"term":"Pain of skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":12}],"term":"Petechiae"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Photosensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":30}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":70,"numEvents":25}],"term":"Rash desquamating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":70,"numEvents":20}],"term":"Skin disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Skin hypopigmentation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":70,"numEvents":17}],"term":"Sweating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Urticaria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Flushing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":6}],"term":"Hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":70,"numEvents":68}],"term":"Hot flashes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":70,"numEvents":185}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Vascular disorder"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Eye pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Cecal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Jejunal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":70,"numEvents":5}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Small intestinal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Disease progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":3}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Wound dehiscence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Cardiac troponin T increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Myelodysplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Intracranial hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Ischemia cerebrovascular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Speech disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Proteinuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Pulmonary hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Rash desquamating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Sweating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra9.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":3}],"term":"Thrombosis"}]}