{"description":"In original protocol, subjects were planned to be randomized 1:1 into 2 cohorts: Acala 100 mg BIDx28 days and 200 mg QDx28 days respectively. After enrollment started, 6 pts received Acala 200 mg QD (5 pts previously treated,1 pt treatment naïve).Per safety and occupancy data in CLL pts, a protocol amendment was made on 13MAR2015, and the 6 pts on 200 mg QD were switched to 100 BID for the remainder of the study. Median 200 mg QD exposure prior to switch was 6.9 \\[range: 2.4-13.8\\] months.","eventGroups":[{"deathsNumAffected":26,"deathsNumAtRisk":87,"description":"PT 100 mg BID (n = 87)","id":"EG000","otherNumAffected":87,"otherNumAtRisk":87,"seriousNumAffected":56,"seriousNumAtRisk":87,"title":"Previously Treated (PT) Cohort 1"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"PT 200 mg QD (n = 5)","id":"EG001","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":3,"seriousNumAtRisk":5,"title":"Previously Treated (PT) Cohort 2"},{"deathsNumAffected":26,"deathsNumAtRisk":92,"description":"PT 100 mg BID + 200 mg QD (N = 92)","id":"EG002","otherNumAffected":92,"otherNumAtRisk":92,"seriousNumAffected":59,"seriousNumAtRisk":92,"title":"Previously Treated (PT) Total"},{"deathsNumAffected":1,"deathsNumAtRisk":13,"description":"TN 100 mg BID (N = 13)","id":"EG003","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":9,"seriousNumAtRisk":13,"title":"Treatment Naive (TN) Cohort 1"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"TN 200 mg QD (n = 1)","id":"EG004","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Treatment Naive (TN) Cohort 2"},{"deathsNumAffected":1,"deathsNumAtRisk":14,"description":"TN 100 mg BID + 200 mg QD (n = 14)","id":"EG005","otherNumAffected":14,"otherNumAtRisk":14,"seriousNumAffected":9,"seriousNumAtRisk":14,"title":"Treatment Naive (TN) Total"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":87,"numEvents":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":92,"numEvents":20},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cold type haemolytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":87,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":10,"numAtRisk":92,"numEvents":11},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Increased tendency to bruise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Microcytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":87,"numEvents":50},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":20,"numAtRisk":92,"numEvents":50},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":23},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":23},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Thymic cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Arteriosclerosis coronary artery"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":87,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cardiac amyloidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cardiogenic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Sinus arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Deafness unilateral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ear congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Eustachian tube dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Excessive cerumen production"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyperacusis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tympanic membrane perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyperparathyroidism primary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Angle closure glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Conjunctival haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eye haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eye swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eye ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Metamorphopsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ocular discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Ocular hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Periorbital swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Photopsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Retinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Scleral hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Trichiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Vitreous detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vitreous floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Abdominal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":87,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":9,"numAtRisk":92,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":3}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Abdominal tenderness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Anal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Anal incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bowel movement irregularity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":87,"numEvents":25},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":23,"numAtRisk":92,"numEvents":26},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":4,"numAtRisk":14,"numEvents":4}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Crohn's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Defaecation urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":87,"numEvents":54},{"groupId":"EG001","numAffected":4,"numAtRisk":5,"numEvents":7},{"groupId":"EG002","numAffected":34,"numAtRisk":92,"numEvents":61},{"groupId":"EG003","numAffected":6,"numAtRisk":13,"numEvents":10},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":6,"numAtRisk":14,"numEvents":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":87,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":12,"numAtRisk":92,"numEvents":15},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eructation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Faeces soft"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Food poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haemorrhoidal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hiatus hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Intestinal mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Large intestine polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lip erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":7},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":87,"numEvents":26},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG002","numAffected":21,"numAtRisk":92,"numEvents":29},{"groupId":"EG003","numAffected":4,"numAtRisk":13,"numEvents":5},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":5,"numAtRisk":14,"numEvents":6}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Noninfective gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Oral blood blister"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Retching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":3}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tongue ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":87,"numEvents":21},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":16,"numAtRisk":92,"numEvents":21},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Crepitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":87,"numEvents":39},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":29,"numAtRisk":92,"numEvents":41},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":5}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Feeling cold"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Fibrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gravitational oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":5}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":87,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":92,"numEvents":14},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Physical deconditioning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":87,"numEvents":22},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":15,"numAtRisk":92,"numEvents":24},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":5}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vaccination site rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Vessel puncture site bruise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vessel puncture site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Vessel puncture site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Biliary colic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Allergic reaction to excipient"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Allergy to arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Seasonal allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":87,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":8,"numAtRisk":92,"numEvents":13},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Covid-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":87,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Epididymitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Epiglottitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Escherichia urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eyelid infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gastroenteritis norovirus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Herpes simplex"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Herpes virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hordeolum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":92,"numEvents":11},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Labyrinthitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Laryngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Localised infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":87,"numEvents":34},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":19,"numAtRisk":92,"numEvents":34},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":87,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":92,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Onychomycosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Otitis externa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pharyngitis streptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pneumococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Post procedural cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":87,"numEvents":21},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":12,"numAtRisk":92,"numEvents":21},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Respiratory tract infection viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":87,"numEvents":11},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":92,"numEvents":11},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rhinovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":87,"numEvents":17},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG002","numAffected":12,"numAtRisk":92,"numEvents":20},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Subcutaneous abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Superinfection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tinea infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":87,"numEvents":38},{"groupId":"EG001","numAffected":3,"numAtRisk":5,"numEvents":6},{"groupId":"EG002","numAffected":27,"numAtRisk":92,"numEvents":44},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":6},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":4,"numAtRisk":14,"numEvents":7}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":87,"numEvents":34},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":12,"numAtRisk":92,"numEvents":34},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Animal bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Back injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":87,"numEvents":36},{"groupId":"EG001","numAffected":3,"numAtRisk":5,"numEvents":6},{"groupId":"EG002","numAffected":27,"numAtRisk":92,"numEvents":42},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Eye contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":87,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG002","numAffected":9,"numAtRisk":92,"numEvents":11},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Foot fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Fractured sacrum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Incision site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Joint dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Joint injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Limb injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lumbar vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Meniscus injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Muscle strain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oral contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Periorbital haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Post procedural contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Road traffic accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Skin abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tendon rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Upper limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":3}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood bilirubin unconjugated increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood calcium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood folate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood immunoglobulin g decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood urine present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cardiac murmur"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Prostatic specific antigen increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Respiratory syncytial virus test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Serum ferritin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vitamin d decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":87,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":15,"numAtRisk":92,"numEvents":15},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Folate deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gout"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Iron deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Polydipsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Type 2 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vitamin b12 deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vitamin d deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":87,"numEvents":38},{"groupId":"EG001","numAffected":3,"numAtRisk":5,"numEvents":5},{"groupId":"EG002","numAffected":29,"numAtRisk":92,"numEvents":43},{"groupId":"EG003","numAffected":5,"numAtRisk":13,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":14,"numEvents":5}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Axillary mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":87,"numEvents":28},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":21,"numAtRisk":92,"numEvents":28},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Bursitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Coccydynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Jaw clicking"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Joint stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Limb discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Muscle mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Musculoskeletal stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":87,"numEvents":20},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":8,"numAtRisk":92,"numEvents":21},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Osteoporosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":87,"numEvents":19},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":15,"numAtRisk":92,"numEvents":19},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":3}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Spondylitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tendonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tenosynovitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Trigger finger"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lipoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Melanocytic naevus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Neoplasm skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oesophageal carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Phyllodes tumour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Seborrhoeic keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Skin papilloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Squamous cell carcinoma of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Carpal tunnel syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dementia alzheimer's type"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":87,"numEvents":24},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":22,"numAtRisk":92,"numEvents":26},{"groupId":"EG003","numAffected":5,"numAtRisk":13,"numEvents":6},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":14,"numEvents":6}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dizziness postural"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Essential tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":5}],"term":"Head discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":87,"numEvents":49},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG002","numAffected":39,"numAtRisk":92,"numEvents":52},{"groupId":"EG003","numAffected":5,"numAtRisk":13,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":14,"numEvents":9}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":87,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hypogeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Intracranial mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Mental impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Muscle contractions involuntary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":87,"numEvents":11},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":92,"numEvents":11},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Parosmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Peripheral sensorimotor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Phrenic nerve paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Restless legs syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Sciatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Sedation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Sensory disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":3}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Taste disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Abnormal dreams"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Claustrophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Depressed mood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hallucination"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":7,"numAtRisk":92,"numEvents":7},{"groupId":"EG003","numAffected":4,"numAtRisk":13,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":14,"numEvents":4}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Poor quality sleep"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Procedural anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Chromaturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Polyuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Renal injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Urine abnormality"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Abnormal uterine bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Benign prostatic hyperplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dyspareunia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ejaculation disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Endometrial thickening"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Erectile dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haematospermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Prostatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Testicular pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Testicular swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vaginal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vulvovaginal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Allergic respiratory symptom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bronchiectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":87,"numEvents":29},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG002","numAffected":24,"numAtRisk":92,"numEvents":32},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":87,"numEvents":15},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":14,"numAtRisk":92,"numEvents":15},{"groupId":"EG003","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":4}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":87,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":12,"numAtRisk":92,"numEvents":16},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lung opacity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Nasal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Nasal septum deviation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":7,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pleurisy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":87,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":10,"numAtRisk":92,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rales"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Respiratory symptom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Respiratory tract congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Sputum retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Actinic keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Blister"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Capillaritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dermatitis bullous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Dermatitis contact"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Drug eruption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":87,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":92,"numEvents":7},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":8,"numAtRisk":92,"numEvents":10},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ingrown hair"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Macule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Nail dystrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Onychoclasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":14,"numEvents":4}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pigmentation disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":87,"numEvents":13},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":13,"numAtRisk":92,"numEvents":14},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":87,"numEvents":17},{"groupId":"EG001","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG002","numAffected":17,"numAtRisk":92,"numEvents":20},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Rash erythematous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Scab"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Seborrhoeic dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Skin discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Skin hypopigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Skin induration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Skin irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":87,"numEvents":19},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":15,"numAtRisk":92,"numEvents":19},{"groupId":"EG003","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":14,"numEvents":3}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Stasis dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Social circumstances","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Walking disability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Tooth extraction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Aortic dilatation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Essential hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":7,"numAtRisk":92,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":92,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pallor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Peripheral venous disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Varicose vein"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vasculitis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Nodal arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Right ventricular failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vestibular disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oesophageal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":92,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Covid-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Covid-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Empyema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Epiglottitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Infective exacerbation of bronchiectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":87,"numEvents":13},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":92,"numEvents":13},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Meningitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Meningitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pharyngitis streptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":87,"numEvents":15},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":92,"numEvents":15},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Prostatitis escherichia coli"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pulmonary sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rhinovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rotavirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Subcutaneous abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":87,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":92,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Blood viscosity increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":92,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Central nervous system lymphoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Colon adenoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gastrointestinal carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Glioblastoma multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lung adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Malignant ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Metastases to liver"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Metastatic malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Oesophageal carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Plasma cell myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Squamous cell carcinoma of the tongue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Intracranial haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Intracranial mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Meningorrhagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Benign prostatic hyperplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Prostatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bronchiectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lung disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":87,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":87,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":92,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":87,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":92,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vasculitis"}],"timeFrame":"Reported Adverse Events (AEs) include events from the first dose of study drug until 30 days after the last dose of the study drug or start of a new anti-cancer therapy (whichever came first), assessed up to approximately 6 years and 7 months."}