{"description":"In the study, AEs were collected during the Open-Label (OL) Pre-Antiviral Treatment Phase and the Double-Blind (DB) Phase, which included antiviral therapy and a 6-month post-therapy follow-up. Data for SAEs and AEs are presented for the Safety Population, comprised of all randomized participants who received the study drug.","eventGroups":[{"description":"Participants with a platelet count of \\<75 giga (10\\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \\<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \\<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \\>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \\>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.","id":"EG000","otherNumAffected":49,"otherNumAtRisk":715,"seriousNumAffected":8,"seriousNumAtRisk":715,"title":"Eltrombopag: OL Phase"},{"description":"Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).","id":"EG001","otherNumAffected":219,"otherNumAtRisk":232,"seriousNumAffected":35,"seriousNumAtRisk":232,"title":"Placebo+Antiviral Therapy: DB Phase"},{"description":"Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \\>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).","id":"EG002","otherNumAffected":424,"otherNumAtRisk":449,"seriousNumAffected":89,"seriousNumAtRisk":449,"title":"Eltrombopag+Antiviral Therapy: DB Phase"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":715},{"groupId":"EG001","numAffected":47,"numAtRisk":232},{"groupId":"EG002","numAffected":107,"numAtRisk":449}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":95,"numAtRisk":232},{"groupId":"EG002","numAffected":170,"numAtRisk":449}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":78,"numAtRisk":232},{"groupId":"EG002","numAffected":183,"numAtRisk":449}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":85,"numAtRisk":232},{"groupId":"EG002","numAffected":69,"numAtRisk":449}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":39,"numAtRisk":232},{"groupId":"EG002","numAffected":70,"numAtRisk":449}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":60,"numAtRisk":232},{"groupId":"EG002","numAffected":139,"numAtRisk":449}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":53,"numAtRisk":232},{"groupId":"EG002","numAffected":139,"numAtRisk":449}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":40,"numAtRisk":232},{"groupId":"EG002","numAffected":70,"numAtRisk":449}],"term":"Influenza Like Illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":34,"numAtRisk":232},{"groupId":"EG002","numAffected":66,"numAtRisk":449}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":20,"numAtRisk":232},{"groupId":"EG002","numAffected":56,"numAtRisk":449}],"term":"Edema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":12,"numAtRisk":232},{"groupId":"EG002","numAffected":58,"numAtRisk":449}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":17,"numAtRisk":232},{"groupId":"EG002","numAffected":46,"numAtRisk":449}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":30,"numAtRisk":232},{"groupId":"EG002","numAffected":86,"numAtRisk":449}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":27,"numAtRisk":232},{"groupId":"EG002","numAffected":82,"numAtRisk":449}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":17,"numAtRisk":232},{"groupId":"EG002","numAffected":31,"numAtRisk":449}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":12,"numAtRisk":232},{"groupId":"EG002","numAffected":33,"numAtRisk":449}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":16,"numAtRisk":232},{"groupId":"EG002","numAffected":27,"numAtRisk":449}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":11,"numAtRisk":232},{"groupId":"EG002","numAffected":29,"numAtRisk":449}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":7,"numAtRisk":232},{"groupId":"EG002","numAffected":32,"numAtRisk":449}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":11,"numAtRisk":232},{"groupId":"EG002","numAffected":28,"numAtRisk":449}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":34,"numAtRisk":232},{"groupId":"EG002","numAffected":77,"numAtRisk":449}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":33,"numAtRisk":232},{"groupId":"EG002","numAffected":30,"numAtRisk":449}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":15,"numAtRisk":232},{"groupId":"EG002","numAffected":38,"numAtRisk":449}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":16,"numAtRisk":232},{"groupId":"EG002","numAffected":28,"numAtRisk":449}],"term":"Dyspnea Exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":9,"numAtRisk":232},{"groupId":"EG002","numAffected":30,"numAtRisk":449}],"term":"Oropharyngeal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":27,"numAtRisk":232},{"groupId":"EG002","numAffected":68,"numAtRisk":449}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":24,"numAtRisk":232},{"groupId":"EG002","numAffected":49,"numAtRisk":449}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":15,"numAtRisk":232},{"groupId":"EG002","numAffected":50,"numAtRisk":449}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":14,"numAtRisk":232},{"groupId":"EG002","numAffected":31,"numAtRisk":449}],"term":"Dry Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":26,"numAtRisk":232},{"groupId":"EG002","numAffected":65,"numAtRisk":449}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":17,"numAtRisk":232},{"groupId":"EG002","numAffected":55,"numAtRisk":449}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":15,"numAtRisk":232},{"groupId":"EG002","numAffected":46,"numAtRisk":449}],"term":"Muscle Spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":10,"numAtRisk":232},{"groupId":"EG002","numAffected":26,"numAtRisk":449}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":24,"numAtRisk":232},{"groupId":"EG002","numAffected":26,"numAtRisk":449}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":44,"numAtRisk":232},{"groupId":"EG002","numAffected":79,"numAtRisk":449}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":11,"numAtRisk":232},{"groupId":"EG002","numAffected":38,"numAtRisk":449}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":13,"numAtRisk":232},{"groupId":"EG002","numAffected":18,"numAtRisk":449}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":8,"numAtRisk":232},{"groupId":"EG002","numAffected":44,"numAtRisk":449}],"term":"Blood Bilirubin Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":9,"numAtRisk":232},{"groupId":"EG002","numAffected":32,"numAtRisk":449}],"term":"White Blood Cell Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":9,"numAtRisk":232},{"groupId":"EG002","numAffected":31,"numAtRisk":449}],"term":"Hemoglobin Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":9,"numAtRisk":232},{"groupId":"EG002","numAffected":25,"numAtRisk":449}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":30,"numAtRisk":232},{"groupId":"EG002","numAffected":78,"numAtRisk":449}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":8,"numAtRisk":232},{"groupId":"EG002","numAffected":39,"numAtRisk":449}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":12,"numAtRisk":232},{"groupId":"EG002","numAffected":24,"numAtRisk":449}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":5,"numAtRisk":232},{"groupId":"EG002","numAffected":38,"numAtRisk":449}],"term":"Hyperbilirubinemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Gastric Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Large Intestine Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":715},{"groupId":"EG001","numAffected":2,"numAtRisk":232},{"groupId":"EG002","numAffected":7,"numAtRisk":449}],"term":"Oesophageal Varices Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":715},{"groupId":"EG001","numAffected":2,"numAtRisk":232},{"groupId":"EG002","numAffected":6,"numAtRisk":449}],"term":"Hepatic Neoplasm Malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":3,"numAtRisk":449}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":715},{"groupId":"EG001","numAffected":2,"numAtRisk":232},{"groupId":"EG002","numAffected":4,"numAtRisk":449}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Hypertensive Crisis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":3,"numAtRisk":232},{"groupId":"EG002","numAffected":4,"numAtRisk":449}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":4,"numAtRisk":449}],"term":"Upper Gastrointestinal Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Gastric Varices Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Gastrointestinal Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Abdominal Discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":2,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Abdominal Strangulated Hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Hematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Intestinal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Oesophageal Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Pancreatitis Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Peptic Ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Periodontitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Abdominal Distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Varices Oesophageal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":4,"numAtRisk":449}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":2,"numAtRisk":232},{"groupId":"EG002","numAffected":3,"numAtRisk":449}],"term":"Peritonitis Bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":3,"numAtRisk":449}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Abscess Limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Septic Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Bacterial Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Diarrhea Infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Disseminated Tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Meningitis Cryptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Prostatic Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Renal Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Subcutaneous Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Acinetobacter Bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Appendicitis Perforated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Dacryocystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Pyelonephritis Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Staphylococcal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":3,"numAtRisk":449}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":3,"numAtRisk":449}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":3,"numAtRisk":449}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Hemolytic Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":7,"numAtRisk":449}],"term":"Hepatic Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Cholecystitis Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Hepatic Function Abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Hepatitis Alcoholic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Hepatorenal Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Hepatic Cirrhosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Portal Vein Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Lung Neoplasm Malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"General Physical Health Deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Edema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Multi-organ Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":4,"numAtRisk":449}],"term":"Hepatic Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Brain Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Coma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Vocal Cord Paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Ruptured Cerebral Aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":2,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Cataract Nuclear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Eye Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Retinal Vein Occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Visual Acuity Reduced"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Renal Failure Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Cystitis Ulcerative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Urethral Polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Dyspnea Exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Pleurisy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Acute Myocardial Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Angina Pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Pleuropericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Angina Unstable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Sinus Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Forearm Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Limb Traumatic Amputation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Traumatic Lung Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Retinal Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Bleeding Varicose Vein"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Venous Thrombosis Limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Varicose Vein"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Blood Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Transaminases Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Bursitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Fasciitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Juvenile Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":2,"numAtRisk":449}],"term":"Mental Status Changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Epidermolysis Bullosa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Deafness Neurosensory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Goitre"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":1,"numAtRisk":232},{"groupId":"EG002","numAffected":0,"numAtRisk":449}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Prostatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Social circumstances","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Alcohol Use"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":715},{"groupId":"EG001","numAffected":0,"numAtRisk":232},{"groupId":"EG002","numAffected":1,"numAtRisk":449}],"term":"Portal Shunt"}],"timeFrame":"Adverse events (AEs) are reported for the Double-blind (DB) on-treatment + 30 days period (up to Study Week 72)."}