{"description":"All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"Participants received 2 mg/kg cabiralizumab IV once every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG000","otherNumAffected":2,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1a: Cabiralizumab 2 mg/kg Q2W"},{"deathsNumAffected":6,"deathsNumAtRisk":10,"description":"Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG001","otherNumAffected":10,"otherNumAtRisk":11,"seriousNumAffected":1,"seriousNumAtRisk":10,"title":"Phase 1a: Cabiralizumab 4 mg/kg Q2W"},{"deathsNumAffected":6,"deathsNumAtRisk":11,"description":"Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG002","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":6,"seriousNumAtRisk":11,"title":"Phase 1a: Cabiralizumab 6 mg/kg Q2W"},{"deathsNumAffected":2,"deathsNumAtRisk":4,"description":"Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG003","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Phase 1a: Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W"},{"deathsNumAffected":3,"deathsNumAtRisk":4,"description":"Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG004","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W"},{"deathsNumAffected":172,"deathsNumAtRisk":265,"description":"Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG005","otherNumAffected":264,"otherNumAtRisk":265,"seriousNumAffected":138,"seriousNumAtRisk":265,"title":"Phase 1a+1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W"},{"deathsNumAffected":4,"deathsNumAtRisk":6,"description":"Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG006","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W"},{"deathsNumAffected":7,"deathsNumAtRisk":10,"description":"Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.","id":"EG007","otherNumAffected":9,"otherNumAtRisk":10,"seriousNumAffected":5,"seriousNumAtRisk":10,"title":"Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":88,"numAtRisk":265},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Anaemia of chronic disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lymph node pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Microcytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Splenic vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Atrial thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Atrioventricular block second degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bundle branch block left"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bundle branch block right"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cardiac tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mitral valve incompetence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":11,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ear discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Autoimmune thyroiditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypercalcaemia of malignancy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypogonadism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypophysitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":16,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Inappropriate antidiuretic hormone secretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Altered visual depth perception"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Asthenopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blepharitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Conjunctival haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Conjunctival hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Conjunctival oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Episcleritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eye allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eye discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eye oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Eye pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eye swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eyelid pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eyelid rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Iridocyclitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":19,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ocular discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ocular hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Optic nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Orbital oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":122,"numAtRisk":265},{"groupId":"EG006","numAffected":5,"numAtRisk":6},{"groupId":"EG007","numAffected":3,"numAtRisk":10}],"term":"Periorbital oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Scleritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Uveitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":23,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Visual acuity reduced"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vitreous floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal compartment syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":21,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":5,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":45,"numAtRisk":265},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Aphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":9,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Autoimmune colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Breath odour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Buccal mucosal roughening"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chronic gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Colitis ischaemic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":69,"numAtRisk":265},{"groupId":"EG006","numAffected":4,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Defaecation urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":69,"numAtRisk":265},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":19,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Duodenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":14,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":25,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Epigastric discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Erosive duodenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Faecal incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Faeces discoloured"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Frequent bowel movements"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gastrointestinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gastrooesophageal sphincter insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Glossitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Glossodynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperchlorhydria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Impaired gastric emptying"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Intestinal dilatation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lip erosion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Lip oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lip swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Loose tooth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":87,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":4,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oesophageal irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oesophageal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral dysaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral mucosal blistering"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Painful defaecation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pancreatic insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Parotid gland enlargement"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Retching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Swollen tongue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tongue disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Tongue oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":60,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":23,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Axillary pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Catheter site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Catheter site inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Catheter site rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":25,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Decreased activity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Device malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Early satiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":24,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":3,"numAtRisk":10}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fat tissue increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":5,"numAtRisk":11},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":148,"numAtRisk":265},{"groupId":"EG006","numAffected":6,"numAtRisk":6},{"groupId":"EG007","numAffected":3,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Feeling abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Feeling cold"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Feeling hot"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Feeling jittery"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":10,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Generalised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypothermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Infusion site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Local swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":12,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Loss of control of legs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Medical device site bruise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mucosal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":54,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":15,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":58,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":52,"numAtRisk":265},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Temperature intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Thirst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Thrombosis in device"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Xerosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bile duct obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hepatic steatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hepatic vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hepatosplenomegaly"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Liver disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Portal vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Seasonal allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Brain abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":11,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":4,"numAtRisk":10}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Enterococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Escherichia bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Escherichia sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Furuncle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gastrointestinal candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hordeolum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oesophageal candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oesophageal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":17,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Parainfluenzae virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":14,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonia klebsiella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonia legionella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Proteus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory moniliasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Scrotal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sialoadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin candida"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Stoma site cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Streptococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":15,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":15,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urinary tract infection enterococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vulvovaginal mycotic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":10,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Corneal abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dural tear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eye burns"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":4,"numAtRisk":10}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Feeding tube complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Foreign body"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fractured sacrum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Incision site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Incisional hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Joint dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Joint injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lower limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Periorbital contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Post procedural discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Post-traumatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pseudomeningocele"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Skin abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Thermal burn"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tooth fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tracheostomy malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vascular access complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Wound necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":59,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Aldolase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ammonia increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":51,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Antineutrophil cytoplasmic antibody increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":5,"numAtRisk":11},{"groupId":"EG002","numAffected":6,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":115,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bacterial test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Band neutrophil count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bilirubin conjugated increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":35,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood creatine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood creatine phosphokinase MB increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":125,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":25,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood glucose decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":37,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood lactic acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood phosphorus decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood phosphorus increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood pressure systolic increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood thyroid stimulating hormone decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood thyroid stimulating hormone increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Body temperature increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Breath sounds abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Electrocardiogram QRS complex prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Enterococcus test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eosinophil count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Globulins increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haematocrit decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Heart rate increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"International normalised ratio increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":49,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Liver function test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":20,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Myoglobin blood increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"N-terminal prohormone brain natriuretic peptide increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Neutrophil count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pancreatic enzymes increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":12,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Platelet count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Protein urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Prothrombin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Red blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory rate increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Thyroxine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tri-iodothyronine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Troponin T increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Troponin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":26,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"White blood cell count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"White blood cells urine positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":68,"numAtRisk":265},{"groupId":"EG006","numAffected":4,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":27,"numAtRisk":265},{"groupId":"EG006","numAffected":5,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dyslipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fluid overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fluid retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperammonaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperamylasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":24,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":14,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperlipasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperlipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":29,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":20,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":39,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":44,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":41,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Increased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Iron deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Type 1 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vitamin B12 deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vitamin D deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":33,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":39,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Exostosis of jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Facial asymmetry"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mobility decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Muscle haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Muscle oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Muscle tightness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Muscle twitching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":20,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":9,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Musculoskeletal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":16,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Musculoskeletal stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":18,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Myopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":15,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":24,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Polymyalgia rheumatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Synovial cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Trigger finger"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Trismus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Acrochordon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bowen's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemorrhagic tumour necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Keratoacanthoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Malignant ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Malignant lymphoid neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tumour flare"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Uterine leiomyoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Carpal tunnel syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":31,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":4,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":17,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Head discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":44,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":12,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sensory disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sinus headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"VIIth nerve paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vasogenic cerebral oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Visual field defect"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":27,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":17,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":11,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":40,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mood altered"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mood swings"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Nightmare"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Obsessive thoughts"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Panic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bladder spasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chromaturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypersthenuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ketonuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urethral spasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urinary hesitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Benign prostatic hyperplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Breast discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Breast mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Breast oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Breast swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dyspareunia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Genital rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Nipple pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vaginal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bronchostenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":70,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":14,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":81,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":11,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":13,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":23,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Laryngeal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Laryngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lung disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lung infiltration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":15,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Nasal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Nasal mucosal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Obstructive airways disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oesophagobronchial fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oropharyngeal plaque"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Orthopnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Paranasal sinus discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Paranasal sinus hypersecretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":26,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":14,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":12,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pulmonary alveolar haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pulmonary hilum mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory tract congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Restrictive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sinus disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sleep apnoea syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sneezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sputum discoloured"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tachypnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Throat tightness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tonsillolith"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":16,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blister"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood blister"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dermatitis contact"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dermatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":15,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":10,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hair texture abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Macule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Nail bed disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Papule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Pemphigoid"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Perivascular dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":62,"numAtRisk":265},{"groupId":"EG006","numAffected":4,"numAtRisk":6},{"groupId":"EG007","numAffected":3,"numAtRisk":10}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pruritus generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pseudofolliculitis barbae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":68,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":3,"numAtRisk":10}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rash erythematous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rash generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":37,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":3,"numAtRisk":10}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rash papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Skin atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Skin plaque"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":12,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Swelling face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Xanthelasma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bloody discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":9,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":2,"numAtRisk":10}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":39,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":17,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pallor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Peripheral coldness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Prehypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Superior vena cava syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Thrombophlebitis superficial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Varicose vein"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":40,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":7,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Small intestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Autoimmune colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Colitis ischaemic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Diverticulum intestinal haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Duodenal ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Duodenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemorrhoidal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Incarcerated inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pancreatic insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":11,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Brain abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Enterococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Infectious pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oesophageal candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pelvic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Peritonitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonia staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sepsis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Streptococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Subcutaneous abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Abdominal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":9,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":6,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Embolic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Brain oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mental impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Optic neuritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"VIIth nerve paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sudden cardiac death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bundle branch block right"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fluid overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Aortic dissection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hypertensive crisis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Jugular vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Superior vena cava syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Feeding tube complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Sternal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Wound haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":8,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Troponin T increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Troponin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Autoimmune hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bile duct obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Bile duct stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Drug-induced liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hepatic vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Portal vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":4,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":5,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":10}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Swelling face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Necrotising granulomatous lymphadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Brain neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Metastatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Tumour thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Inappropriate antidiuretic hormone secretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":11},{"groupId":"EG003","numAffected":0,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":265},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":10}],"term":"Vaginal haemorrhage"}],"timeFrame":"From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups."}