{"description":"All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.","eventGroups":[{"deathsNumAffected":94,"deathsNumAtRisk":105,"description":"Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.","id":"EG000","otherNumAffected":96,"otherNumAtRisk":104,"seriousNumAffected":44,"seriousNumAtRisk":104,"title":"Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course"},{"deathsNumAffected":42,"deathsNumAtRisk":51,"description":"Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.","id":"EG001","otherNumAffected":46,"otherNumAtRisk":51,"seriousNumAffected":21,"seriousNumAtRisk":51,"title":"Cohort 2: HCC-Systemic Therapy Naïve-First Course"},{"deathsNumAffected":2,"deathsNumAtRisk":4,"description":"Participants from Cohort 1 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.","id":"EG002","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Participants from Cohort 2 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.","id":"EG003","otherNumAffected":0,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Cohort 2: HCC-Systemic Therapy Naïve-Second Course"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":104,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":104,"numEvents":9},{"groupId":"EG001","numAffected":6,"numAtRisk":51,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":104,"numEvents":18},{"groupId":"EG001","numAffected":8,"numAtRisk":51,"numEvents":9},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":104,"numEvents":13},{"groupId":"EG001","numAffected":2,"numAtRisk":51,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":104,"numEvents":12},{"groupId":"EG001","numAffected":6,"numAtRisk":51,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":104,"numEvents":18},{"groupId":"EG001","numAffected":4,"numAtRisk":51,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":104,"numEvents":21},{"groupId":"EG001","numAffected":13,"numAtRisk":51,"numEvents":15},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":104,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":51,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":104,"numEvents":21},{"groupId":"EG001","numAffected":4,"numAtRisk":51,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Varices oesophageal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":104,"numEvents":15},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":104,"numEvents":19},{"groupId":"EG001","numAffected":7,"numAtRisk":51,"numEvents":8},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":104,"numEvents":40},{"groupId":"EG001","numAffected":21,"numAtRisk":51,"numEvents":23},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":104,"numEvents":21},{"groupId":"EG001","numAffected":14,"numAtRisk":51,"numEvents":15},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":104,"numEvents":6},{"groupId":"EG001","numAffected":5,"numAtRisk":51,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":104,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":51,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":51,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":104,"numEvents":16},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":104,"numEvents":27},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":51,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":104,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Serum ferritin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":104,"numEvents":18},{"groupId":"EG001","numAffected":8,"numAtRisk":51,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":104,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Vitamin D deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":104,"numEvents":31},{"groupId":"EG001","numAffected":5,"numAtRisk":51,"numEvents":8},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":104,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":51,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":51,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":104,"numEvents":16},{"groupId":"EG001","numAffected":5,"numAtRisk":51,"numEvents":6},{"groupId":"EG002","numAffected":2,"numAtRisk":4,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":104,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":104,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":51,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":104,"numEvents":21},{"groupId":"EG001","numAffected":8,"numAtRisk":51,"numEvents":10},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":104,"numEvents":15},{"groupId":"EG001","numAffected":6,"numAtRisk":51,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":51,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":104,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":104,"numEvents":29},{"groupId":"EG001","numAffected":6,"numAtRisk":51,"numEvents":8},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":104,"numEvents":19},{"groupId":"EG001","numAffected":5,"numAtRisk":51,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rash"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Atrioventricular block second degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cardiogenic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Chronic left ventricular failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ventricular fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypophysitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Retinal vein occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":104,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Autoimmune colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastritis haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Oesophageal varices haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Umbilical hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Varices oesophageal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hepatic cytolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hepatic haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Immune-mediated hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Large intestine infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":104,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":104,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Diabetic ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Diabetic metabolic decompensation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Type 1 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Colon cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Squamous cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Tumour necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":51,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hepatic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Radiculopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":104,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Lichenoid keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":104,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":104,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Hypovolaemic shock"}],"timeFrame":"Up to approximately 87 months"}