{"description":"Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.","eventGroups":[{"description":"Participants received Bendamustine 120 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.","id":"EG000","otherNumAffected":194,"otherNumAtRisk":203,"seriousNumAffected":76,"seriousNumAtRisk":203,"title":"Bendamustine Alone"},{"description":"Induction phase: Participants received Bendamustine 90 mg/m\\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).","id":"EG001","otherNumAffected":200,"otherNumAtRisk":204,"seriousNumAffected":91,"seriousNumAtRisk":204,"title":"Obinutuzumab + Bendamustine"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":203,"numEvents":41},{"groupId":"EG001","numAffected":23,"numAtRisk":204,"numEvents":36}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":203,"numEvents":103},{"groupId":"EG001","numAffected":74,"numAtRisk":204,"numEvents":150}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":203,"numEvents":101},{"groupId":"EG001","numAffected":26,"numAtRisk":204,"numEvents":54}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":203,"numEvents":12},{"groupId":"EG001","numAffected":6,"numAtRisk":204,"numEvents":6}],"term":"ABDOMINAL DISTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":203,"numEvents":23},{"groupId":"EG001","numAffected":16,"numAtRisk":204,"numEvents":18}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":203,"numEvents":19},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":12}],"term":"ABDOMINAL PAIN UPPER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":203,"numEvents":55},{"groupId":"EG001","numAffected":42,"numAtRisk":204,"numEvents":56}],"term":"CONSTIPATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":203,"numEvents":83},{"groupId":"EG001","numAffected":57,"numAtRisk":204,"numEvents":81}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203,"numEvents":15},{"groupId":"EG001","numAffected":8,"numAtRisk":204,"numEvents":8}],"term":"DRY MOUTH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":203,"numEvents":11},{"groupId":"EG001","numAffected":13,"numAtRisk":204,"numEvents":16}],"term":"DYSPEPSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":123,"numAtRisk":203,"numEvents":227},{"groupId":"EG001","numAffected":107,"numAtRisk":204,"numEvents":210}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":203,"numEvents":87},{"groupId":"EG001","numAffected":44,"numAtRisk":204,"numEvents":67}],"term":"VOMITING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":203,"numEvents":35},{"groupId":"EG001","numAffected":31,"numAtRisk":204,"numEvents":44}],"term":"ASTHENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":203,"numEvents":4},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":11}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":203,"numEvents":24},{"groupId":"EG001","numAffected":28,"numAtRisk":204,"numEvents":30}],"term":"CHILLS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":203,"numEvents":114},{"groupId":"EG001","numAffected":81,"numAtRisk":204,"numEvents":151}],"term":"FATIGUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":203,"numEvents":10},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":12}],"term":"INFLUENZA LIKE ILLNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":203,"numEvents":11},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":12}],"term":"MUCOSAL INFLAMMATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":203,"numEvents":17},{"groupId":"EG001","numAffected":15,"numAtRisk":204,"numEvents":16}],"term":"OEDEMA PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":203,"numEvents":44},{"groupId":"EG001","numAffected":54,"numAtRisk":204,"numEvents":80}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":203,"numEvents":23},{"groupId":"EG001","numAffected":24,"numAtRisk":204,"numEvents":36}],"term":"BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":203,"numEvents":16},{"groupId":"EG001","numAffected":10,"numAtRisk":204,"numEvents":10}],"term":"HERPES ZOSTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":203,"numEvents":10},{"groupId":"EG001","numAffected":22,"numAtRisk":204,"numEvents":27}],"term":"NASOPHARYNGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":203,"numEvents":9},{"groupId":"EG001","numAffected":12,"numAtRisk":204,"numEvents":13}],"term":"RHINITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":203,"numEvents":14},{"groupId":"EG001","numAffected":24,"numAtRisk":204,"numEvents":35}],"term":"SINUSITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":203,"numEvents":21},{"groupId":"EG001","numAffected":26,"numAtRisk":204,"numEvents":34}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203,"numEvents":14},{"groupId":"EG001","numAffected":23,"numAtRisk":204,"numEvents":36}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":115,"numAtRisk":203,"numEvents":242},{"groupId":"EG001","numAffected":125,"numAtRisk":204,"numEvents":283}],"term":"INFUSION RELATED REACTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":203,"numEvents":18},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":11}],"term":"WEIGHT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":203,"numEvents":49},{"groupId":"EG001","numAffected":37,"numAtRisk":204,"numEvents":40}],"term":"DECREASED APPETITE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":203,"numEvents":21},{"groupId":"EG001","numAffected":15,"numAtRisk":204,"numEvents":22}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":203,"numEvents":12},{"groupId":"EG001","numAffected":24,"numAtRisk":204,"numEvents":31}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":203,"numEvents":22},{"groupId":"EG001","numAffected":17,"numAtRisk":204,"numEvents":19}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":203,"numEvents":17},{"groupId":"EG001","numAffected":13,"numAtRisk":204,"numEvents":14}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":203,"numEvents":13},{"groupId":"EG001","numAffected":22,"numAtRisk":204,"numEvents":27}],"term":"PAIN IN EXTREMITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":203,"numEvents":23},{"groupId":"EG001","numAffected":14,"numAtRisk":204,"numEvents":22}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":203,"numEvents":20},{"groupId":"EG001","numAffected":15,"numAtRisk":204,"numEvents":20}],"term":"DYSGEUSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":203,"numEvents":37},{"groupId":"EG001","numAffected":27,"numAtRisk":204,"numEvents":36}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":203,"numEvents":26},{"groupId":"EG001","numAffected":21,"numAtRisk":204,"numEvents":24}],"term":"INSOMNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":203,"numEvents":46},{"groupId":"EG001","numAffected":64,"numAtRisk":204,"numEvents":85}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":203,"numEvents":28},{"groupId":"EG001","numAffected":26,"numAtRisk":204,"numEvents":27}],"term":"DYSPNOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":203,"numEvents":6},{"groupId":"EG001","numAffected":17,"numAtRisk":204,"numEvents":18}],"term":"NASAL CONGESTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":203,"numEvents":7},{"groupId":"EG001","numAffected":12,"numAtRisk":204,"numEvents":15}],"term":"OROPHARYNGEAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":11}],"term":"RHINORRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203,"numEvents":13},{"groupId":"EG001","numAffected":29,"numAtRisk":204,"numEvents":38}],"term":"PRURITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":203,"numEvents":27},{"groupId":"EG001","numAffected":28,"numAtRisk":204,"numEvents":35}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":23,"numAtRisk":204,"numEvents":26}],"term":"HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":203,"numEvents":14},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":11}],"term":"PHLEBITIS"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"AGRANULOCYTOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":204,"numEvents":3}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":203,"numEvents":6},{"groupId":"EG001","numAffected":11,"numAtRisk":204,"numEvents":17}],"term":"FEBRILE NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":204,"numEvents":6}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":204,"numEvents":5}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"ATRIAL FIBRILLATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"ATRIAL FLUTTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":3}],"term":"CARDIAC FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"CORONARY ARTERY DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":2}],"term":"MYOCARDIAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"PAROXYSMAL ARRHYTHMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"HYDROCELE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"NECROTISING RETINITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"ABDOMINAL PAIN UPPER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"ANAL FISSURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"COLITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"FOOD POISONING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"GASTROINTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"HAEMATOCHEZIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"INTESTINAL PERFORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"LARGE INTESTINAL OBSTRUCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"MELAENA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"PANCREATITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"RECTAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"UPPER GASTROINTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"VOMITING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"CATHETER SITE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"FATIGUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":204,"numEvents":4}],"term":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"HYPERTHERMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"INFLUENZA LIKE ILLNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"MALAISE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":204,"numEvents":7}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"CHOLECYSTITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"GRAFT VERSUS HOST DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"ATYPICAL PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"BACTERAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"CAMPYLOBACTER INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"COXSACKIE MYOCARDITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"DEVICE RELATED SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"ENCEPHALITIS VIRAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"ENDOCARDITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"ERYSIPELAS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"ESCHERICHIA SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"FUNGAL SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"GASTROENTERITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"GASTROENTERITIS NOROVIRUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"HEPATITIS B REACTIVATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"HERPES ZOSTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":204,"numEvents":3}],"term":"LOWER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"LUNG INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"LUNG INFECTION PSEUDOMONAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"NEUTROPENIC SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"PNEUMOCYSTIS JIROVECII PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203,"numEvents":12},{"groupId":"EG001","numAffected":7,"numAtRisk":204,"numEvents":7}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"PNEUMONIA CYTOMEGALOVIRAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"PSEUDOMONAL SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"PSEUDOMONAS BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"RESPIRATORY SYNCYTIAL VIRUS INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":2}],"term":"RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":203,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":204,"numEvents":6}],"term":"SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"SEPTIC SHOCK"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"SINUSITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"STAPHYLOCOCCAL SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"TOOTH INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":204,"numEvents":3}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"UROSEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"VASCULAR DEVICE INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"FEMUR FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"HEAD INJURY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"HIP FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":204,"numEvents":7}],"term":"INFUSION RELATED REACTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"JAW FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"POST PROCEDURAL BILE LEAK"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"SEROMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"STAB WOUND"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"VASCULAR PSEUDOANEURYSM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"WRIST FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"BLOOD CREATININE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"BORRELIA TEST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"DEHYDRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"HYPERGLYCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"TUMOUR LYSIS SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"MUSCLE HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"OSTEOARTHRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"ACUTE MYELOID LEUKAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"ADENOCARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"ADENOCARCINOMA GASTRIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"BASAL CELL CARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"BLADDER CANCER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"BREAST CANCER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"BRONCHIAL NEOPLASM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"CHOLANGIOCARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"COLORECTAL CANCER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"INTESTINAL ADENOCARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"LEIOMYOSARCOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"LEUKAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"LUNG NEOPLASM MALIGNANT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"MALIGNANT MELANOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":204,"numEvents":3}],"term":"MYELODYSPLASTIC SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"POLYCYTHAEMIA VERA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"RENAL CANCER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"SQUAMOUS CELL CARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"T-CELL LYMPHOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"THYROID NEOPLASM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"AMYOTROPHIC LATERAL SCLEROSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"CENTRAL NERVOUS SYSTEM LESION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"ISCHAEMIC STROKE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"POST HERPETIC NEURALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"PRESYNCOPE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"SUBARACHNOID HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"SYNCOPE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"MANIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"DYSURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"END STAGE RENAL DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"HAEMATURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"POLLAKIURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"URETERIC OBSTRUCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"URINARY INCONTINENCE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"BENIGN PROSTATIC HYPERPLASIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"BRONCHOSPASM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"CHYLOTHORAX"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"EMPHYSEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"HYPOXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"PLEURAL EFFUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"PNEUMONIA ASPIRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"PNEUMOTHORAX"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":203,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":204,"numEvents":1}],"term":"PULMONARY EMBOLISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"PARANEOPLASTIC PEMPHIGUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Social circumstances","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"SOCIAL PROBLEM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"CIRCULATORY COLLAPSE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":204,"numEvents":0}],"term":"DEEP VEIN THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":204,"numEvents":2}],"term":"HYPOTENSION"}],"timeFrame":"Baseline up to 8.5 years"}