{"description":"Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.\n\nThe table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.","eventGroups":[{"description":"Cetuximab 400 mg/m\\^2 as an initial dose, followed by 250 mg/m\\^2 intravenously (IV) every 7 days.","id":"EG000","otherNumAffected":474,"otherNumAtRisk":503,"seriousNumAffected":169,"seriousNumAtRisk":503,"title":"Cetuximab"},{"description":"Panitumumab 6 mg/kg IV every 14 days.","id":"EG001","otherNumAffected":459,"otherNumAtRisk":496,"seriousNumAffected":151,"seriousNumAtRisk":496,"title":"Panitumumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":503},{"groupId":"EG001","numAffected":29,"numAtRisk":496}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":503},{"groupId":"EG001","numAffected":52,"numAtRisk":496}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":503},{"groupId":"EG001","numAffected":39,"numAtRisk":496}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":87,"numAtRisk":503},{"groupId":"EG001","numAffected":88,"numAtRisk":496}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":503},{"groupId":"EG001","numAffected":19,"numAtRisk":496}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":503},{"groupId":"EG001","numAffected":66,"numAtRisk":496}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":503},{"groupId":"EG001","numAffected":26,"numAtRisk":496}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":503},{"groupId":"EG001","numAffected":49,"numAtRisk":496}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":503},{"groupId":"EG001","numAffected":30,"numAtRisk":496}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":503},{"groupId":"EG001","numAffected":72,"numAtRisk":496}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":503},{"groupId":"EG001","numAffected":22,"numAtRisk":496}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":503},{"groupId":"EG001","numAffected":28,"numAtRisk":496}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":75,"numAtRisk":503},{"groupId":"EG001","numAffected":58,"numAtRisk":496}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":503},{"groupId":"EG001","numAffected":14,"numAtRisk":496}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":503},{"groupId":"EG001","numAffected":26,"numAtRisk":496}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":77,"numAtRisk":503},{"groupId":"EG001","numAffected":69,"numAtRisk":496}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":503},{"groupId":"EG001","numAffected":26,"numAtRisk":496}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":503},{"groupId":"EG001","numAffected":41,"numAtRisk":496}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":89,"numAtRisk":503},{"groupId":"EG001","numAffected":134,"numAtRisk":496}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":503},{"groupId":"EG001","numAffected":34,"numAtRisk":496}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":503},{"groupId":"EG001","numAffected":17,"numAtRisk":496}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":503},{"groupId":"EG001","numAffected":27,"numAtRisk":496}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":503},{"groupId":"EG001","numAffected":40,"numAtRisk":496}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":503},{"groupId":"EG001","numAffected":19,"numAtRisk":496}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":503},{"groupId":"EG001","numAffected":52,"numAtRisk":496}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":503},{"groupId":"EG001","numAffected":138,"numAtRisk":496}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":503},{"groupId":"EG001","numAffected":83,"numAtRisk":496}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":503},{"groupId":"EG001","numAffected":26,"numAtRisk":496}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":503},{"groupId":"EG001","numAffected":83,"numAtRisk":496}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":257,"numAtRisk":503},{"groupId":"EG001","numAffected":249,"numAtRisk":496}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":503},{"groupId":"EG001","numAffected":42,"numAtRisk":496}],"term":"Skin fissures"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":503},{"groupId":"EG001","numAffected":6,"numAtRisk":496}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Cardiovascular insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Abdominal mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":503},{"groupId":"EG001","numAffected":10,"numAtRisk":496}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":3,"numAtRisk":496}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":503},{"groupId":"EG001","numAffected":5,"numAtRisk":496}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":503},{"groupId":"EG001","numAffected":6,"numAtRisk":496}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Duodenal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Duodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Gastrointestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":503},{"groupId":"EG001","numAffected":5,"numAtRisk":496}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Intestinal infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":503},{"groupId":"EG001","numAffected":12,"numAtRisk":496}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Mesenteric vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Obturator hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Peritoneal adhesions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Rectal polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Rectal tenesmus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":503},{"groupId":"EG001","numAffected":4,"numAtRisk":496}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Small intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":503},{"groupId":"EG001","numAffected":12,"numAtRisk":496}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":503},{"groupId":"EG001","numAffected":6,"numAtRisk":496}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Device occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":503},{"groupId":"EG001","numAffected":4,"numAtRisk":496}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hyperpyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Performance status decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":503},{"groupId":"EG001","numAffected":3,"numAtRisk":496}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Systemic inflammatory response syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Bile duct obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Cholestasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Hepatic lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hepatocellular injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":3,"numAtRisk":496}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Jaundice extrahepatic obstructive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Abdominal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Bronchopneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Enterococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Escherichia infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Furuncle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Gastrointestinal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Infected dermal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Lobar pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Nail infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Pyelonephritis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Pyonephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":5,"numAtRisk":496}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Subcutaneous abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Urinary bladder abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":503},{"groupId":"EG001","numAffected":9,"numAtRisk":496}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Cervical vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Joint dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Scapula fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Soft tissue injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Blood creatine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Red blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Diabetes mellitus inadequate control"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Fluid overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":4,"numAtRisk":496}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":3,"numAtRisk":496}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":4,"numAtRisk":496}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Muscle haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":503},{"groupId":"EG001","numAffected":5,"numAtRisk":496}],"term":"Colon cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":503},{"groupId":"EG001","numAffected":4,"numAtRisk":496}],"term":"Colon cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":503},{"groupId":"EG001","numAffected":7,"numAtRisk":496}],"term":"Colorectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":503},{"groupId":"EG001","numAffected":7,"numAtRisk":496}],"term":"Colorectal cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Infected neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Metastases to bone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":4,"numAtRisk":496}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Metastases to liver"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Metastases to meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Metastases to ovary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Metastases to spine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Rectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Tumour necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Tumour thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Altered state of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Carotid artery stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Central nervous system lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Dyskinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Azotaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Bladder dilatation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":4,"numAtRisk":496}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Obstructive uropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Oliguria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Renal failure chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Ureteric stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Female genital tract fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Oedema genital"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Perineal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":503},{"groupId":"EG001","numAffected":3,"numAtRisk":496}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":2,"numAtRisk":496}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Respiratory depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Central venous catheterisation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Salpingo-oophorectomy bilateral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Artery dissection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Lymphocele"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":503},{"groupId":"EG001","numAffected":0,"numAtRisk":496}],"term":"Superior vena cava syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":503},{"groupId":"EG001","numAffected":1,"numAtRisk":496}],"term":"Thrombosis"}],"timeFrame":"Median time was 117 days for panitumumab arm and 123 days for cetuximab arm."}