{"description":"Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.","eventGroups":[{"deathsNumAffected":6,"deathsNumAtRisk":41,"description":"AEs collected during on-treatment period with dabrafenib and trametinib in the HGG cohort (up to 30 days post- treatment)","id":"EG000","otherNumAffected":41,"otherNumAtRisk":41,"seriousNumAffected":28,"seriousNumAtRisk":41,"title":"HGG Cohort: Dabrafenib and Trametinib (On-treatment)"},{"deathsNumAffected":11,"deathsNumAtRisk":13,"description":"Deaths collected in the post- treatment follow-up period for participants in the HGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)"},{"deathsNumAffected":0,"deathsNumAtRisk":73,"description":"AEs collected during on-treatment period with dabrafenib and trametinib in the LGG cohort (up to 30 days post- treatment)","id":"EG002","otherNumAffected":73,"otherNumAtRisk":73,"seriousNumAffected":34,"seriousNumAtRisk":73,"title":"LGG Cohort: Dabrafenib and Trametinib (On-treatment)"},{"deathsNumAffected":0,"deathsNumAtRisk":11,"description":"Deaths collected in the post- treatment follow-up period for participants in the LGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period","id":"EG003","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)"},{"deathsNumAffected":0,"deathsNumAtRisk":33,"description":"AEs collected during on-treatment period with carboplatin and vincristine in the LGG cohort (up to 30 days post- treatment or start date of crossover treatment, whichever was earlier)","id":"EG004","otherNumAffected":33,"otherNumAtRisk":33,"seriousNumAffected":14,"seriousNumAtRisk":33,"title":"LGG Cohort: Carboplatin and Vincristine (On-treatment)"},{"deathsNumAffected":0,"deathsNumAtRisk":16,"description":"Deaths collected in the post- treatment follow-up period (starting from day 31 post- treatment) for participants in the LGG cohort treated with carboplatin and vincristine. No AEs were collected during this period","id":"EG005","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up)"},{"deathsNumAffected":1,"deathsNumAtRisk":12,"description":"AEs collected during crossover on-treatment period with dabrafenib and trametinib for participants in the LGG cohort randomized to carboplatin and vincristine who crossedover to dabrafenib and trametinib after disease progression (up to 30 days post- crossover treatment)","id":"EG006","otherNumAffected":11,"otherNumAtRisk":12,"seriousNumAffected":4,"seriousNumAtRisk":12,"title":"LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment)"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Deaths collected in the crossover post- treatment follow-up period (starting from day 31 post- crossover treatment) for participants in the LGG cohort treated with carboplatin and vincristine who crossed over to dabrafenib and trametinib. No AEs were collected during this period","id":"EG007","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up)"}],"frequencyThreshold":"4.9999","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":14,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":20,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":10,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":10,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Aortic valve incompetence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Eyelid ptosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":15,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":7,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":13,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Angular cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Aphthous ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":10,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":12,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":27,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":6,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":21,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":17,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":3,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":25,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":17,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":6,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Facial pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":25,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":10,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":51,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":7,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":6,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":26,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":3,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":9,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":17,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":7,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":16,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":10,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":9,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":9,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":3,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":7,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Blood bicarbonate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":5,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":11,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":16,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":10,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"SARS-CoV-2 test negative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":12,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":9,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":12,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Cerebral salt-wasting syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":8,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":6,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Obesity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":9,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":7,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":7,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":13,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":6,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":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":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":10,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Skin papilloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":8,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":39,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":8,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":7,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":5,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Device malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Intentional self-injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":11,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":3,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":16,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":10,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":7,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":4,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":4,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":10,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":9,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":10,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":20,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":13,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":12,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":5,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Erythema nodosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hand dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ingrowing nail"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Keratosis pilaris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Panniculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Papule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":9,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":14,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":3,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":13,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":5,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Skin striae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":9},{"groupId":"EG007","numAtRisk":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Growth hormone deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Thyroid disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Uveitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Food poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hyperpyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pulpitis dental"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Respiratory tract infection viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tinea manuum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Skin abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tibia fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Blood pressure decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":6,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"SARS-CoV-2 test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Streptococcus test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Vitamin D deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Immobilisation syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Somatic symptom disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Snoring"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tonsillar hypertrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dermatitis contact"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dyshidrotic eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":2,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rash erythematous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rash papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":4,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Skin lesion"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":9},{"groupId":"EG007","numAtRisk":0}],"term":"Ventricular enlargement"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Detachment of retinal pigment epithelium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":9},{"groupId":"EG007","numAtRisk":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":12,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":6,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":2,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Bacterial sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Brain abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Encephalomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Laryngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":9},{"groupId":"EG007","numAtRisk":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":3,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Toxic shock syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Urinary tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Varicella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Viral myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Procedural complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Shunt malfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tooth avulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":9},{"groupId":"EG007","numAtRisk":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Oxygen saturation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Altered state of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Cerebral ventricle dilatation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Cerebrospinal fluid circulation disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Intracranial pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Ischaemic cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Migraine with aura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Partial seizures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Renal colic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Uterine haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":2,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Apnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Erythema nodosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Papilloedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Haematological infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":1,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Vulvitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Road traffic accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Central nervous system lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Optic perineuritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":0,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (24.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41},{"groupId":"EG001","numAtRisk":0},{"groupId":"EG002","numAffected":1,"numAtRisk":73},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":33},{"groupId":"EG005","numAtRisk":0},{"groupId":"EG006","numAffected":0,"numAtRisk":12},{"groupId":"EG007","numAtRisk":0}],"term":"Tonsillar hypertrophy"}],"timeFrame":"On-treatment AEs: from first dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment deaths: from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG).Crossover on-treatment: AEs from first dose to 30 days after last dose of crossover treatment, up to 4.2 years."}