{"description":"The population consisted of all participants who received at least one dose of study drug.","eventGroups":[{"description":"Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"title":"Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.","id":"EG002","otherNumAffected":6,"otherNumAtRisk":8,"seriousNumAffected":2,"seriousNumAtRisk":8,"title":"Dalotuzumab 5 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.","id":"EG003","otherNumAffected":5,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Dalotuzumab 10 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.","id":"EG004","otherNumAffected":4,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Dalotuzumab 10 mg/kg Q1W (20 mg/mL)"},{"description":"Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.","id":"EG005","otherNumAffected":5,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Dalotuzumab 15 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.","id":"EG006","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":3,"seriousNumAtRisk":8,"title":"Dalotuzumab 15 mg/kg Q1W (20 mg/mL)"},{"description":"Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.","id":"EG007","otherNumAffected":6,"otherNumAtRisk":7,"seriousNumAffected":0,"seriousNumAtRisk":7,"title":"Dalotuzumab 20 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.","id":"EG008","otherNumAffected":8,"otherNumAtRisk":9,"seriousNumAffected":2,"seriousNumAtRisk":9,"title":"Dalotuzumab 20 mg/kg Q1W (20 mg/mL)"},{"description":"Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.","id":"EG009","otherNumAffected":9,"otherNumAtRisk":11,"seriousNumAffected":3,"seriousNumAtRisk":11,"title":"Dalotuzumab 20 mg/kg Q2W (20 mg/mL)"},{"description":"Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.","id":"EG010","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":1,"seriousNumAtRisk":11,"title":"Dalotuzumab 30 mg/kg Q3W (20 mg/mL)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Lymph node pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":4}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":2},{"groupId":"EG010","numAffected":3,"numAtRisk":11,"numEvents":5}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":4}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":8,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":8,"numEvents":5},{"groupId":"EG007","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG008","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG009","numAffected":3,"numAtRisk":11,"numEvents":3},{"groupId":"EG010","numAffected":5,"numAtRisk":11,"numEvents":6}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Bronchiectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":8,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"Blood cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Blood glucose decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":9,"numEvents":5},{"groupId":"EG009","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"Blood triglycerides increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":9,"numEvents":5},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":8,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":6,"numEvents":6},{"groupId":"EG006","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG007","numAffected":1,"numAtRisk":7,"numEvents":2},{"groupId":"EG008","numAffected":3,"numAtRisk":9,"numEvents":4},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":3},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":8,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":3,"numAtRisk":11,"numEvents":4}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Myopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Infected neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Malignant ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG007","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG008","numAffected":3,"numAtRisk":9,"numEvents":6},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Increased upper airway secretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Lymphoedema"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Skin bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Colon cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Ewing's sarcoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Leukocytoclastic vasculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":11,"numEvents":0}],"term":"Deep vein thrombosis"}],"timeFrame":"Up to 30 days after last dose of study drug (Up to 25 months)"}