{"eventGroups":[{"description":"Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.","id":"EG000","otherNumAffected":79,"otherNumAtRisk":176,"seriousNumAffected":14,"seriousNumAtRisk":176,"title":"Placebo -Treatment Period"},{"description":"Baricitinib 2mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.","id":"EG001","otherNumAffected":105,"otherNumAtRisk":174,"seriousNumAffected":8,"seriousNumAtRisk":174,"title":"Baricitinib 2 mg - Treatment Period"},{"description":"Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.","id":"EG002","otherNumAffected":102,"otherNumAtRisk":177,"seriousNumAffected":19,"seriousNumAtRisk":177,"title":"Baricitinib 4 mg - Treatment Period"},{"description":"Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.","id":"EG003","otherNumAffected":6,"otherNumAtRisk":127,"seriousNumAffected":2,"seriousNumAtRisk":127,"title":"Rescue Period"},{"description":"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.","id":"EG004","otherNumAffected":2,"otherNumAtRisk":19,"seriousNumAffected":1,"seriousNumAtRisk":19,"title":"Placebo - Follow Up Period"},{"description":"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.","id":"EG005","otherNumAffected":4,"otherNumAtRisk":9,"seriousNumAffected":1,"seriousNumAtRisk":9,"title":"Baricitinib 2 mg - Follow Up Period"},{"description":"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.","id":"EG006","otherNumAffected":1,"otherNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"title":"Baricitinib 4 mg - Follow Up Period"}],"frequencyThreshold":"2","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Episcleritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":176,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":174,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":7,"numAtRisk":174,"numEvents":7},{"groupId":"EG002","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":176,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":176,"numEvents":12},{"groupId":"EG001","numAffected":10,"numAtRisk":174,"numEvents":10},{"groupId":"EG002","numAffected":7,"numAtRisk":177,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":174,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":176,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":174,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":176,"numEvents":6},{"groupId":"EG001","numAffected":7,"numAtRisk":174,"numEvents":9},{"groupId":"EG002","numAffected":10,"numAtRisk":177,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":176,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":174,"numEvents":6},{"groupId":"EG002","numAffected":3,"numAtRisk":177,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":7,"numAtRisk":174,"numEvents":8},{"groupId":"EG002","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":176,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":174,"numEvents":7},{"groupId":"EG002","numAffected":10,"numAtRisk":177,"numEvents":12},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":145,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":137,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":149,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":113,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":16,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cervicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":176,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":6,"numAtRisk":177,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":174,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":177,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":8,"numAtRisk":177,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":176,"numEvents":7},{"groupId":"EG001","numAffected":12,"numAtRisk":174,"numEvents":13},{"groupId":"EG002","numAffected":9,"numAtRisk":177,"numEvents":10},{"groupId":"EG003","numAffected":4,"numAtRisk":127,"numEvents":5},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":5,"numAtRisk":177,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":174,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":174,"numEvents":8},{"groupId":"EG002","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":176,"numEvents":8},{"groupId":"EG001","numAffected":15,"numAtRisk":174,"numEvents":17},{"groupId":"EG002","numAffected":9,"numAtRisk":177,"numEvents":11},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":176,"numEvents":6},{"groupId":"EG001","numAffected":7,"numAtRisk":174,"numEvents":10},{"groupId":"EG002","numAffected":8,"numAtRisk":177,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":145,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":137,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":149,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":113,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":16,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Vulvovaginal candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":176,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":177,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":177,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":6,"numAtRisk":177,"numEvents":8},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":7,"numAtRisk":177,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":174,"numEvents":3},{"groupId":"EG002","numAffected":5,"numAtRisk":177,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hyperlipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":176,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":174,"numEvents":4},{"groupId":"EG002","numAffected":5,"numAtRisk":177,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":176,"numEvents":6},{"groupId":"EG001","numAffected":8,"numAtRisk":174,"numEvents":8},{"groupId":"EG002","numAffected":6,"numAtRisk":177,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":174,"numEvents":3},{"groupId":"EG002","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":174,"numEvents":6},{"groupId":"EG002","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":176,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":174,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":174,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":176,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":174,"numEvents":6},{"groupId":"EG002","numAffected":8,"numAtRisk":177,"numEvents":10},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Rheumatoid arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":176,"numEvents":12},{"groupId":"EG001","numAffected":17,"numAtRisk":174,"numEvents":17},{"groupId":"EG002","numAffected":12,"numAtRisk":177,"numEvents":12},{"groupId":"EG003","numAffected":3,"numAtRisk":127,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":176,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":174,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":177,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":174,"numEvents":6},{"groupId":"EG002","numAffected":5,"numAtRisk":177,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":174,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":176,"numEvents":4},{"groupId":"EG001","numAffected":7,"numAtRisk":174,"numEvents":7},{"groupId":"EG002","numAffected":9,"numAtRisk":177,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Haemorrhagic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Motion sickness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Vertigo positional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Diverticulum intestinal haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Oral disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Medical device complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Campylobacter gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Intervertebral discitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":145,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":137,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":149,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":113,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":16,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":18,"numEvents":0}],"term":"Vulval abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Accident at work"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Acetabulum fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Alcohol poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Bone contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Cardiac contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Concussion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Facial bones fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Fractured sacrum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hand fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Lower limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Muscle rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Road traffic accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Ulna fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":176,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":177,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Rheumatoid arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Synovitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Basilar artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":127,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Carpal tunnel syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Transient global amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Vertebral artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Pulmonary mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":174,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Hypertensive crisis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Peripheral arterial occlusive disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":174,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":127,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":20,"numEvents":0}],"term":"Peripheral embolism"}]}