{"description":"At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population included all enrolled participants who received at least 1 dose of any study drug.","eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":662,"description":"Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\\^2), vinblastine 6 mg/m\\^2, and dacarbazine 375 mg/m\\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.","id":"EG000","otherNumAffected":644,"otherNumAtRisk":662,"seriousNumAffected":284,"seriousNumAtRisk":662,"title":"A+AVD"},{"deathsNumAffected":13,"deathsNumAtRisk":659,"description":"Doxorubicin 25 mg/m\\^2, bleomycin 10 units per square meter (units/m\\^2), vinblastine 6 mg/m\\^2, and dacarbazine 375 mg/m\\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.","id":"EG001","otherNumAffected":632,"otherNumAtRisk":659,"seriousNumAffected":178,"seriousNumAtRisk":659,"title":"ABVD"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":374,"numAtRisk":662,"numEvents":1169},{"groupId":"EG001","numAffected":291,"numAtRisk":659,"numEvents":813}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":662,"numEvents":237},{"groupId":"EG001","numAffected":65,"numAtRisk":659,"numEvents":97}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":662,"numEvents":124},{"groupId":"EG001","numAffected":37,"numAtRisk":659,"numEvents":118}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":346,"numAtRisk":662,"numEvents":673},{"groupId":"EG001","numAffected":369,"numAtRisk":659,"numEvents":735}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":273,"numAtRisk":662,"numEvents":361},{"groupId":"EG001","numAffected":239,"numAtRisk":659,"numEvents":336}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":212,"numAtRisk":662,"numEvents":342},{"groupId":"EG001","numAffected":183,"numAtRisk":659,"numEvents":284}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":176,"numAtRisk":662,"numEvents":231},{"groupId":"EG001","numAffected":121,"numAtRisk":659,"numEvents":155}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":138,"numAtRisk":662,"numEvents":182},{"groupId":"EG001","numAffected":104,"numAtRisk":659,"numEvents":135}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":135,"numAtRisk":662,"numEvents":185},{"groupId":"EG001","numAffected":65,"numAtRisk":659,"numEvents":79}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":662,"numEvents":100},{"groupId":"EG001","numAffected":75,"numAtRisk":659,"numEvents":93}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":662,"numEvents":74},{"groupId":"EG001","numAffected":34,"numAtRisk":659,"numEvents":37}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":662,"numEvents":36},{"groupId":"EG001","numAffected":47,"numAtRisk":659,"numEvents":49}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":209,"numAtRisk":662,"numEvents":272},{"groupId":"EG001","numAffected":211,"numAtRisk":659,"numEvents":293}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":149,"numAtRisk":662,"numEvents":224},{"groupId":"EG001","numAffected":128,"numAtRisk":659,"numEvents":191}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":662,"numEvents":97},{"groupId":"EG001","numAffected":42,"numAtRisk":659,"numEvents":66}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":662,"numEvents":52},{"groupId":"EG001","numAffected":46,"numAtRisk":659,"numEvents":51}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":662,"numEvents":40},{"groupId":"EG001","numAffected":45,"numAtRisk":659,"numEvents":53}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":68,"numAtRisk":662,"numEvents":76},{"groupId":"EG001","numAffected":69,"numAtRisk":659,"numEvents":75}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":662,"numEvents":39},{"groupId":"EG001","numAffected":35,"numAtRisk":659,"numEvents":40}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":148,"numAtRisk":662,"numEvents":168},{"groupId":"EG001","numAffected":40,"numAtRisk":659,"numEvents":46}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":86,"numAtRisk":662,"numEvents":285},{"groupId":"EG001","numAffected":78,"numAtRisk":659,"numEvents":191}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":68,"numAtRisk":662,"numEvents":92},{"groupId":"EG001","numAffected":26,"numAtRisk":659,"numEvents":28}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":662,"numEvents":81},{"groupId":"EG001","numAffected":34,"numAtRisk":659,"numEvents":59}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":662,"numEvents":58},{"groupId":"EG001","numAffected":19,"numAtRisk":659,"numEvents":21}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":662,"numEvents":41},{"groupId":"EG001","numAffected":10,"numAtRisk":659,"numEvents":13}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":118,"numAtRisk":662,"numEvents":156},{"groupId":"EG001","numAffected":76,"numAtRisk":659,"numEvents":106}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":662,"numEvents":50},{"groupId":"EG001","numAffected":24,"numAtRisk":659,"numEvents":35}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":662,"numEvents":44},{"groupId":"EG001","numAffected":14,"numAtRisk":659,"numEvents":18}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":125,"numAtRisk":662,"numEvents":200},{"groupId":"EG001","numAffected":66,"numAtRisk":659,"numEvents":87}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":89,"numAtRisk":662,"numEvents":113},{"groupId":"EG001","numAffected":77,"numAtRisk":659,"numEvents":98}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":662,"numEvents":127},{"groupId":"EG001","numAffected":70,"numAtRisk":659,"numEvents":87}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":662,"numEvents":108},{"groupId":"EG001","numAffected":67,"numAtRisk":659,"numEvents":93}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":82,"numAtRisk":662,"numEvents":96},{"groupId":"EG001","numAffected":49,"numAtRisk":659,"numEvents":59}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":662,"numEvents":48},{"groupId":"EG001","numAffected":29,"numAtRisk":659,"numEvents":34}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":662,"numEvents":41},{"groupId":"EG001","numAffected":17,"numAtRisk":659,"numEvents":18}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":189,"numAtRisk":662,"numEvents":298},{"groupId":"EG001","numAffected":111,"numAtRisk":659,"numEvents":149}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":174,"numAtRisk":662,"numEvents":261},{"groupId":"EG001","numAffected":85,"numAtRisk":659,"numEvents":103}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":93,"numAtRisk":662,"numEvents":124},{"groupId":"EG001","numAffected":92,"numAtRisk":659,"numEvents":117}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":662,"numEvents":120},{"groupId":"EG001","numAffected":73,"numAtRisk":659,"numEvents":89}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":662,"numEvents":74},{"groupId":"EG001","numAffected":57,"numAtRisk":659,"numEvents":65}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":662,"numEvents":52},{"groupId":"EG001","numAffected":48,"numAtRisk":659,"numEvents":68}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":662,"numEvents":50},{"groupId":"EG001","numAffected":8,"numAtRisk":659,"numEvents":9}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":126,"numAtRisk":662,"numEvents":134},{"groupId":"EG001","numAffected":82,"numAtRisk":659,"numEvents":89}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":662,"numEvents":53},{"groupId":"EG001","numAffected":49,"numAtRisk":659,"numEvents":52}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":662,"numEvents":36},{"groupId":"EG001","numAffected":25,"numAtRisk":659,"numEvents":27}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":97,"numAtRisk":662,"numEvents":108},{"groupId":"EG001","numAffected":122,"numAtRisk":659,"numEvents":139}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":662,"numEvents":97},{"groupId":"EG001","numAffected":121,"numAtRisk":659,"numEvents":136}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":662,"numEvents":82},{"groupId":"EG001","numAffected":55,"numAtRisk":659,"numEvents":65}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":662,"numEvents":41},{"groupId":"EG001","numAffected":28,"numAtRisk":659,"numEvents":31}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":173,"numAtRisk":662,"numEvents":194},{"groupId":"EG001","numAffected":146,"numAtRisk":659,"numEvents":165}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":662,"numEvents":60},{"groupId":"EG001","numAffected":28,"numAtRisk":659,"numEvents":33}],"term":"Rash maculo-papular"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":114,"numAtRisk":662,"numEvents":151},{"groupId":"EG001","numAffected":43,"numAtRisk":659,"numEvents":52}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":662,"numEvents":30},{"groupId":"EG001","numAffected":4,"numAtRisk":659,"numEvents":5}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":662,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":3}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Lymphadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Lymphadenopathy mediastinal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Histiocytosis haematophagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":662,"numEvents":19},{"groupId":"EG001","numAffected":15,"numAtRisk":659,"numEvents":18}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":662,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":3}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Atypical pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":662,"numEvents":15},{"groupId":"EG001","numAffected":4,"numAtRisk":659,"numEvents":4}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":662,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":659,"numEvents":4}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":662,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Septic embolus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":662,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Lymph gland infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Pelvic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Laryngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pharyngeal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":662,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Cellulitis orbital"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":662,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":3}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pneumocystis jirovecii infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Abdominal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Enteritis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Subcutaneous abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pneumonia viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pericoronitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Periodontitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Aspergillus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Genital infection female"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Vulvitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Fungal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Herpes virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Ophthalmic herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Infected lymphocele"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Phlebitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Endocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Encephalitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Flavivirus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":2}],"term":"Hepatitis B"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Moraxella infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Parainfluenzae virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pneumonia streptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":662,"numEvents":55},{"groupId":"EG001","numAffected":28,"numAtRisk":659,"numEvents":32}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":3}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Catheter site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Infusion site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Complication associated with device"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Adverse drug reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Device related thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":662,"numEvents":15},{"groupId":"EG001","numAffected":4,"numAtRisk":659,"numEvents":4}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":662,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":662,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":662,"numEvents":12},{"groupId":"EG001","numAffected":6,"numAtRisk":659,"numEvents":7}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":662,"numEvents":13},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":662,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Neutropenic colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":4}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":662,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Ileus paralytic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Anal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":662,"numEvents":11},{"groupId":"EG001","numAffected":9,"numAtRisk":659,"numEvents":9}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pulmonary thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":12,"numAtRisk":659,"numEvents":13}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":659,"numEvents":6}],"term":"Pulmonary toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Lung infiltration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Organising pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":659,"numEvents":5}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":659,"numEvents":4}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Acute pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Lung disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Respiratory disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pleurisy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":662,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":662,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":3}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Type 2 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":662,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":3}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Thrombophlebitis superficial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Jugular vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pelvic venous thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Peripheral artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Venous thrombosis limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":662,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":659,"numEvents":4}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Venous thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Brachiocephalic vein occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Superior vena cava syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Vena cava thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":659,"numEvents":3}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Polyneuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Lacunar infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Autonomic neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Spinal cord ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Microvascular coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":659,"numEvents":2}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Atrial thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Pseudomonas test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Staphylococcus test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Body temperature increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Gallbladder obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Liver disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Schizoaffective disorder bipolar type"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Suicidal ideation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Neuroendocrine tumour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Pituitary tumour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"T-cell lymphoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Bile duct cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Gastrointestinal stromal tumour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Benign ovarian tumour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Plasma cell myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":662,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Ankle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":662,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Anuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Ureteric obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Hidradenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Drug eruption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Metrorrhagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":662,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":659,"numEvents":0}],"term":"Branchial cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Cushing's syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":662,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":659,"numEvents":1}],"term":"Vision blurred"}],"timeFrame":"TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (approximately 1 year) for a serious adverse event after the last dose of study drug"}