{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Phase I (Tablet) Cobimetinib (0.6 mg/kg)"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG001","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Phase I (Tablet) Cobimetinib (0.8 mg/kg)"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG002","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Phase I (Tablet) Cobimetinib (1 mg/kg)"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG003","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Phase I (Suspension) Cobimetinib (0.6 mg/kg)"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG004","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":1,"seriousNumAtRisk":7,"title":"Phase I (Suspension) Cobimetinib (0.8 mg/kg)"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG005","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":2,"seriousNumAtRisk":8,"title":"Phase I (Suspension) Cobimetinib (1 mg/kg)"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG006","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Phase I (Suspension) Cobimetinib (1.33 mg/kg)"},{"deathsNumAffected":0,"deathsNumAtRisk":12,"description":"Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.","id":"EG007","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":5,"seriousNumAtRisk":12,"title":"Phase II (Suspension) Cobimetinib (1 mg/kg)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":12,"numEvents":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Iris hamartoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Precocious puberty"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chorioretinopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Conjunctivitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Corneal neovascularisation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Detachment of retinal pigment epithelium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Eye disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Eyelid ptosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Eyelid skin dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Miosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ocular hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ocular hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Optic atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Optic disc disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Punctate keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Retinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Serous retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Visual acuity reduced transiently"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Visual field defect"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":3,"numAtRisk":12,"numEvents":7}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anorectal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Aphthous ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":12,"numEvents":3}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":6,"numEvents":17},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":8},{"groupId":"EG003","numAffected":4,"numAtRisk":6,"numEvents":6},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":4,"numAtRisk":8,"numEvents":6},{"groupId":"EG006","numAffected":4,"numAtRisk":5,"numEvents":10},{"groupId":"EG007","numAffected":4,"numAtRisk":12,"numEvents":11}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Faeces hard"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Glossodynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lip haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lip ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":7},{"groupId":"EG005","numAffected":3,"numAtRisk":8,"numEvents":5},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tongue ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tooth impacted"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":9},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":9},{"groupId":"EG005","numAffected":4,"numAtRisk":8,"numEvents":7},{"groupId":"EG006","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":7,"numAtRisk":12,"numEvents":14}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":3,"numAtRisk":8,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG007","numAffected":3,"numAtRisk":12,"numEvents":5}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Xerosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Anorectal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"H1N1 influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hand-foot-and-mouth disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hordeolum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Impetigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Localised infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nail infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rhinovirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Scarlet fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Suspected COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Varicella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Viral tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Face injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Foot fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Foreign body in ear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hand fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Limb injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Skin abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Thermal burn"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tooth fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Wrist fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":3}],"term":"Anion gap increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Blood bicarbonate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":3}],"term":"Blood chloride increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":12,"numEvents":8}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Blood creatinine decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Body temperature decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Body temperature increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cortisol decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Intraocular pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":4}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lymphocyte count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Mean cell volume increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":5}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Neutrophil count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Oxygen saturation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Platelet count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":3}],"term":"Protein total decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":9},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":8}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"White blood cell count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Glucose tolerance impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":6},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Spinal deformity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hair follicle tumour benign"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Skin papilloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG004","numAffected":3,"numAtRisk":7,"numEvents":8},{"groupId":"EG005","numAffected":4,"numAtRisk":8,"numEvents":4},{"groupId":"EG006","numAffected":3,"numAtRisk":5,"numEvents":5},{"groupId":"EG007","numAffected":7,"numAtRisk":12,"numEvents":11}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sciatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Behaviour disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Bradyphrenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Inappropriate affect"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Polyuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urinary hesitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Balanoposthitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Scrotal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Vulvovaginal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":12,"numEvents":5}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":4,"numAtRisk":12,"numEvents":5}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Sputum decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Dandruff"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":5,"numEvents":3},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Dermatitis atopic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dermatitis contact"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Eczema asteatotic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hand dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hirsutism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Ingrowing nail"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Miliaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Onychomadesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Papule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Photosensitivity reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pityriasis alba"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":12,"numEvents":2}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Rash erythematous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":5},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":2}],"term":"Rash papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Seborrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin fissures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Telangiectasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Xeroderma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Cardiac ventricular thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Chorioretinopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Vascular device infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":12,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":5,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Pneumothorax"}],"timeFrame":"Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)"}