{"description":"Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.","eventGroups":[{"deathsNumAffected":76,"deathsNumAtRisk":108,"description":"Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":108,"otherNumAtRisk":108,"seriousNumAffected":46,"seriousNumAtRisk":108,"title":"Cohort A: FGFR2 Rearrangements or Fusions"},{"deathsNumAffected":18,"deathsNumAtRisk":20,"description":"Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":20,"otherNumAtRisk":20,"seriousNumAffected":10,"seriousNumAtRisk":20,"title":"Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions"},{"deathsNumAffected":15,"deathsNumAtRisk":17,"description":"Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.","id":"EG002","otherNumAffected":17,"otherNumAtRisk":17,"seriousNumAffected":12,"seriousNumAtRisk":17,"title":"Cohort C: Negative for FGF/FGFR Alterations"},{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.","id":"EG003","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"title":"Other"},{"deathsNumAffected":111,"deathsNumAtRisk":147,"description":"Total","id":"EG004","otherNumAffected":147,"otherNumAtRisk":147,"seriousNumAffected":68,"seriousNumAtRisk":147,"title":"Total"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":10,"numAtRisk":147,"numEvents":11}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":108,"numEvents":39},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":29,"numAtRisk":147,"numEvents":46}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":108,"numEvents":16},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":14,"numAtRisk":147,"numEvents":19}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Accidental overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Acinetobacter bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":4}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":8,"numAtRisk":147,"numEvents":9}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":108,"numEvents":16},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":13,"numAtRisk":147,"numEvents":17}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":108,"numEvents":66},{"groupId":"EG001","numAffected":4,"numAtRisk":20,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG004","numAffected":73,"numAtRisk":147,"numEvents":75}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":108,"numEvents":27},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":20,"numAtRisk":147,"numEvents":31}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":108,"numEvents":52},{"groupId":"EG001","numAffected":5,"numAtRisk":20,"numEvents":8},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":44,"numAtRisk":147,"numEvents":63}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":147,"numEvents":5}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":16},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":12,"numAtRisk":147,"numEvents":21}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":108,"numEvents":34},{"groupId":"EG001","numAffected":4,"numAtRisk":20,"numEvents":9},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":20,"numAtRisk":147,"numEvents":44}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":108,"numEvents":34},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":30,"numAtRisk":147,"numEvents":37}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Bacterial vaginosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Bilirubin conjugated increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":5}],"term":"Blood 1,25-dihydroxycholecalciferol decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":4}],"term":"Blood 1,25-dihydroxycholecalciferol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Blood 25-hydroxycholecalciferol decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":108,"numEvents":16},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":15,"numAtRisk":147,"numEvents":19}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":10}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":5}],"term":"Blood chloride decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":12},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":17,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":15,"numAtRisk":147,"numEvents":18}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":6}],"term":"Blood parathyroid hormone decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":4}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":4}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":10}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":8,"numAtRisk":147,"numEvents":10}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":5}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Chorioretinal scar"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Coma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":3}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":9,"numAtRisk":147,"numEvents":11}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":108,"numEvents":68},{"groupId":"EG001","numAffected":5,"numAtRisk":20,"numEvents":6},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":54,"numAtRisk":147,"numEvents":77}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":108,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":12,"numAtRisk":147,"numEvents":14}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":7}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":108,"numEvents":39},{"groupId":"EG001","numAffected":7,"numAtRisk":20,"numEvents":10},{"groupId":"EG002","numAffected":7,"numAtRisk":17,"numEvents":8},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG004","numAffected":49,"numAtRisk":147,"numEvents":59}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":108,"numEvents":17},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":17,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":21,"numAtRisk":147,"numEvents":24}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":9,"numAtRisk":147,"numEvents":9}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":108,"numEvents":169},{"groupId":"EG001","numAffected":5,"numAtRisk":20,"numEvents":15},{"groupId":"EG002","numAffected":6,"numAtRisk":17,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":70,"numAtRisk":147,"numEvents":191}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":108,"numEvents":23},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":21,"numAtRisk":147,"numEvents":25}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":108,"numEvents":45},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":41,"numAtRisk":147,"numEvents":48}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":108,"numEvents":49},{"groupId":"EG001","numAffected":5,"numAtRisk":20,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG004","numAffected":50,"numAtRisk":147,"numEvents":57}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":108,"numEvents":33},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG004","numAffected":32,"numAtRisk":147,"numEvents":35}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":108,"numEvents":49},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG004","numAffected":53,"numAtRisk":147,"numEvents":59}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":108,"numEvents":17},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":16,"numAtRisk":147,"numEvents":19}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":6}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":108,"numEvents":12},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":16,"numAtRisk":147,"numEvents":18}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":4}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":4}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Episcleritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":108,"numEvents":24},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":20,"numAtRisk":147,"numEvents":25}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":8,"numAtRisk":147,"numEvents":9}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Eye discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":6}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":13},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":9,"numAtRisk":147,"numEvents":14}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":108,"numEvents":60},{"groupId":"EG001","numAffected":5,"numAtRisk":20,"numEvents":6},{"groupId":"EG002","numAffected":9,"numAtRisk":17,"numEvents":9},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":64,"numAtRisk":147,"numEvents":75}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":7}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":108,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":16,"numAtRisk":147,"numEvents":17}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Generalised tonic-clonic seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":8,"numAtRisk":147,"numEvents":8}],"term":"Growth of eyelashes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Gynaecomastia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hallucination"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":108,"numEvents":32},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":23,"numAtRisk":147,"numEvents":35}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":12,"numAtRisk":147,"numEvents":12}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":108,"numEvents":18},{"groupId":"EG001","numAffected":4,"numAtRisk":20,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":21,"numAtRisk":147,"numEvents":25}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":5}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":108,"numEvents":109},{"groupId":"EG001","numAffected":13,"numAtRisk":20,"numEvents":14},{"groupId":"EG002","numAffected":12,"numAtRisk":17,"numEvents":13},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":86,"numAtRisk":147,"numEvents":137}],"term":"Hyperphosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":12,"numAtRisk":147,"numEvents":15}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hypertrichosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":9,"numAtRisk":147,"numEvents":10}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":7}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":5}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":10,"numAtRisk":147,"numEvents":11}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":4,"numAtRisk":20,"numEvents":6},{"groupId":"EG002","numAffected":4,"numAtRisk":17,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":14,"numAtRisk":147,"numEvents":22}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":108,"numEvents":49},{"groupId":"EG001","numAffected":4,"numAtRisk":20,"numEvents":6},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":34,"numAtRisk":147,"numEvents":57}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":9,"numAtRisk":147,"numEvents":14}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hypovitaminosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":7}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":108,"numEvents":13},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":15,"numAtRisk":147,"numEvents":15}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":5,"numAtRisk":147,"numEvents":5}],"term":"Keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Klebsiella infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":108,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":12}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Laryngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":8}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Malignant ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Malignant pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":108,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":13,"numAtRisk":147,"numEvents":14}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":7}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":108,"numEvents":19},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":18,"numAtRisk":147,"numEvents":22}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":108,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":14,"numAtRisk":147,"numEvents":14}],"term":"Nail discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":6}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":108,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":12,"numAtRisk":147,"numEvents":15}],"term":"Nail dystrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":11,"numAtRisk":147,"numEvents":12}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":108,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":13,"numAtRisk":147,"numEvents":14}],"term":"Nasal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":8}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":108,"numEvents":71},{"groupId":"EG001","numAffected":7,"numAtRisk":20,"numEvents":10},{"groupId":"EG002","numAffected":7,"numAtRisk":17,"numEvents":7},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG004","numAffected":60,"numAtRisk":147,"numEvents":90}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":7}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Nervousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":9,"numAtRisk":147,"numEvents":10}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":147,"numEvents":6}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":6}],"term":"Ocular hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":108,"numEvents":21},{"groupId":"EG001","numAffected":4,"numAtRisk":20,"numEvents":4},{"groupId":"EG002","numAffected":6,"numAtRisk":17,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":26,"numAtRisk":147,"numEvents":31}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":9,"numAtRisk":147,"numEvents":10}],"term":"Onychoclasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":13,"numAtRisk":147,"numEvents":13}],"term":"Onycholysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":108,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":14,"numAtRisk":147,"numEvents":15}],"term":"Onychomadesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":7}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":108,"numEvents":13},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":13,"numAtRisk":147,"numEvents":15}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Osteoporotic fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":147,"numEvents":5}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":108,"numEvents":41},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":29,"numAtRisk":147,"numEvents":45}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":108,"numEvents":34},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":24,"numAtRisk":147,"numEvents":36}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":10,"numAtRisk":147,"numEvents":10}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Penile pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Performance status decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Peritonitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":4}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":15},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":10,"numAtRisk":147,"numEvents":17}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":5}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Presbyopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":108,"numEvents":15},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":15,"numAtRisk":147,"numEvents":17}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":10,"numAtRisk":147,"numEvents":10}],"term":"Punctate keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":108,"numEvents":20},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":16,"numAtRisk":147,"numEvents":25}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":108,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":13,"numAtRisk":147,"numEvents":15}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Retching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Sinus pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Skin disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":7}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":147,"numEvents":5}],"term":"Skin fissures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Skin mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":2}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":108,"numEvents":74},{"groupId":"EG001","numAffected":6,"numAtRisk":20,"numEvents":10},{"groupId":"EG002","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":56,"numAtRisk":147,"numEvents":88}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Subretinal fluid"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":5}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":108,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":9}],"term":"Taste disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Thirst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":4}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":147,"numEvents":6}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Tri-iodothyronine free increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":108,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":13,"numAtRisk":147,"numEvents":13}],"term":"Trichiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Trichomegaly"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Trichomoniasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":8}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":108,"numEvents":33},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":26,"numAtRisk":147,"numEvents":39}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":3}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":108,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":12,"numAtRisk":147,"numEvents":12}],"term":"Vitamin D deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":7}],"term":"Vitreous floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":108,"numEvents":55},{"groupId":"EG001","numAffected":3,"numAtRisk":20,"numEvents":3},{"groupId":"EG002","numAffected":4,"numAtRisk":17,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":42,"numAtRisk":147,"numEvents":63}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Vulvovaginal candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":108,"numEvents":23},{"groupId":"EG001","numAffected":4,"numAtRisk":20,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG004","numAffected":26,"numAtRisk":147,"numEvents":29}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":147,"numEvents":9}],"term":"Weight increased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":108,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":9}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":3}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Biliary obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":2}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Biloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":6,"numAtRisk":147,"numEvents":9}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Cholangitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":2}],"term":"Complication associated with device"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Device leakage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":3}],"term":"Device occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Embolic cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Enterobacter bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":2}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hypercalcaemia of malignancy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Inappropriate antidiuretic hormone secretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":147,"numEvents":3}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Kidney infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Malignant biliary obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Oesophageal varices haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Optic ischaemic neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Paraplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":20,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":147,"numEvents":5}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":5}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Pneumonia pneumococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Prostate cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Pseudomonal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":108,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":147,"numEvents":9}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Retinal artery occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":7}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Typhoid fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":108,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":108,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":147,"numEvents":3}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Varices oesophageal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":108,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":147,"numEvents":1}],"term":"Vomiting"}],"timeFrame":"up to 1584 days"}