{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors","id":"EG000","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"PART 1 Dose 1 (7 mg)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors","id":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"PART 1 Dose 2 (20 mg)"},{"deathsNumAffected":2,"deathsNumAtRisk":22,"description":"INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors","id":"EG002","otherNumAffected":21,"otherNumAtRisk":22,"seriousNumAffected":8,"seriousNumAtRisk":22,"title":"PART 1 Dose 3 (70 mg)"},{"deathsNumAffected":4,"deathsNumAtRisk":18,"description":"INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors","id":"EG003","otherNumAffected":17,"otherNumAtRisk":18,"seriousNumAffected":9,"seriousNumAtRisk":18,"title":"PART 1 Dose 4 (200 mg)"},{"deathsNumAffected":2,"deathsNumAtRisk":23,"description":"INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors","id":"EG004","otherNumAffected":22,"otherNumAtRisk":23,"seriousNumAffected":9,"seriousNumAtRisk":23,"title":"PART 1 Dose 5 (350 mg)"},{"deathsNumAffected":3,"deathsNumAtRisk":12,"description":"INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors","id":"EG005","otherNumAffected":10,"otherNumAtRisk":12,"seriousNumAffected":5,"seriousNumAtRisk":12,"title":"PART 1 Dose 6 (700 mg)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors","id":"EG006","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"PART 1 Dose 7 (1400 mg)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":18},{"groupId":"EG004","numAffected":4,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":4,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":2,"numAtRisk":12},{"groupId":"EG006","numAffected":2,"numAtRisk":4}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":3,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":5,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":2,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":2,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":4,"numAtRisk":22},{"groupId":"EG003","numAffected":6,"numAtRisk":18},{"groupId":"EG004","numAffected":4,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":4,"numAtRisk":22},{"groupId":"EG003","numAffected":5,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":3,"numAtRisk":4},{"groupId":"EG002","numAffected":6,"numAtRisk":22},{"groupId":"EG003","numAffected":4,"numAtRisk":18},{"groupId":"EG004","numAffected":7,"numAtRisk":23},{"groupId":"EG005","numAffected":3,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":4,"numAtRisk":18},{"groupId":"EG004","numAffected":3,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":18},{"groupId":"EG004","numAffected":3,"numAtRisk":23},{"groupId":"EG005","numAffected":2,"numAtRisk":12},{"groupId":"EG006","numAffected":2,"numAtRisk":4}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":2,"numAtRisk":12},{"groupId":"EG006","numAffected":2,"numAtRisk":4}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Early satiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Epigastric discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":6,"numAtRisk":22},{"groupId":"EG003","numAffected":7,"numAtRisk":18},{"groupId":"EG004","numAffected":8,"numAtRisk":23},{"groupId":"EG005","numAffected":4,"numAtRisk":12},{"groupId":"EG006","numAffected":2,"numAtRisk":4}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Haemorrhage urinary tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Haemothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hallucination"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Joint injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Lymph node palpable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":22,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":23,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":4,"numEvents":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Meniscus injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":22,"numEvents":5},{"groupId":"EG003","numAffected":3,"numAtRisk":18},{"groupId":"EG004","numAffected":6,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":2,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pruritus generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Seasonal allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Thrombophlebitis superficial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Tooth fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Tumour pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":5,"numAtRisk":22},{"groupId":"EG003","numAffected":3,"numAtRisk":18},{"groupId":"EG004","numAffected":4,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Wound infection"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":2,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Cauda equina syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":1,"numAtRisk":4}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Lower respiratory tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":3,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Myelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pneumonia streptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":2,"numAtRisk":18},{"groupId":"EG004","numAffected":2,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":1,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":0,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":18},{"groupId":"EG004","numAffected":1,"numAtRisk":23},{"groupId":"EG005","numAffected":0,"numAtRisk":12},{"groupId":"EG006","numAffected":0,"numAtRisk":4}],"term":"Vomiting"}],"timeFrame":"From screening through 60 days after end of treatment, up to 11 months"}