{"description":"Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Safety Analysis Population included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm.","eventGroups":[{"description":"Eight cycles of rituximab IV infusion (375 mg/m\\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\\^2) once every 8 weeks for 24 months.","id":"EG000","otherNumAffected":187,"otherNumAtRisk":210,"seriousNumAffected":76,"seriousNumAtRisk":210,"title":"Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)"},{"description":"First cycle of rituximab IV infusion (375 mg/m\\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.","id":"EG001","otherNumAffected":186,"otherNumAtRisk":197,"seriousNumAffected":74,"seriousNumAtRisk":197,"title":"Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":210},{"groupId":"EG001","numAffected":65,"numAtRisk":197}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":210},{"groupId":"EG001","numAffected":50,"numAtRisk":197}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":210},{"groupId":"EG001","numAffected":34,"numAtRisk":197}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":210},{"groupId":"EG001","numAffected":29,"numAtRisk":197}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":210},{"groupId":"EG001","numAffected":29,"numAtRisk":197}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":210},{"groupId":"EG001","numAffected":16,"numAtRisk":197}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":27,"numAtRisk":197}],"term":"Injection site erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":210},{"groupId":"EG001","numAffected":42,"numAtRisk":197}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":210},{"groupId":"EG001","numAffected":35,"numAtRisk":197}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":210},{"groupId":"EG001","numAffected":29,"numAtRisk":197}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":210},{"groupId":"EG001","numAffected":16,"numAtRisk":197}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":210},{"groupId":"EG001","numAffected":9,"numAtRisk":197}],"term":"Mucosal inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":210},{"groupId":"EG001","numAffected":14,"numAtRisk":197}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":16,"numAtRisk":197}],"term":"Injection site pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":210},{"groupId":"EG001","numAffected":65,"numAtRisk":197}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":210},{"groupId":"EG001","numAffected":30,"numAtRisk":197}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":210},{"groupId":"EG001","numAffected":13,"numAtRisk":197}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":210},{"groupId":"EG001","numAffected":30,"numAtRisk":197}],"term":"Paraesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":210},{"groupId":"EG001","numAffected":24,"numAtRisk":197}],"term":"Neuropathy peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":210},{"groupId":"EG001","numAffected":16,"numAtRisk":197}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":210},{"groupId":"EG001","numAffected":27,"numAtRisk":197}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":210},{"groupId":"EG001","numAffected":20,"numAtRisk":197}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":210},{"groupId":"EG001","numAffected":18,"numAtRisk":197}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":210},{"groupId":"EG001","numAffected":16,"numAtRisk":197}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":210},{"groupId":"EG001","numAffected":26,"numAtRisk":197}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":210},{"groupId":"EG001","numAffected":22,"numAtRisk":197}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":210},{"groupId":"EG001","numAffected":17,"numAtRisk":197}],"term":"Muscle spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":210},{"groupId":"EG001","numAffected":28,"numAtRisk":197}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":210},{"groupId":"EG001","numAffected":19,"numAtRisk":197}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":210},{"groupId":"EG001","numAffected":20,"numAtRisk":197}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":210},{"groupId":"EG001","numAffected":20,"numAtRisk":197}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":210},{"groupId":"EG001","numAffected":30,"numAtRisk":197}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":210},{"groupId":"EG001","numAffected":16,"numAtRisk":197}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":210},{"groupId":"EG001","numAffected":22,"numAtRisk":197}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":210},{"groupId":"EG001","numAffected":15,"numAtRisk":197}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":210},{"groupId":"EG001","numAffected":14,"numAtRisk":197}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":210},{"groupId":"EG001","numAffected":49,"numAtRisk":197}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":210},{"groupId":"EG001","numAffected":16,"numAtRisk":197}],"term":"Oropharyngeal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":210},{"groupId":"EG001","numAffected":21,"numAtRisk":197}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":210},{"groupId":"EG001","numAffected":19,"numAtRisk":197}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":210},{"groupId":"EG001","numAffected":11,"numAtRisk":197}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":210},{"groupId":"EG001","numAffected":12,"numAtRisk":197}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":210},{"groupId":"EG001","numAffected":10,"numAtRisk":197}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":210},{"groupId":"EG001","numAffected":5,"numAtRisk":197}],"term":"Influenza like illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":210},{"groupId":"EG001","numAffected":9,"numAtRisk":197}],"term":"Conjunctivitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":210},{"groupId":"EG001","numAffected":9,"numAtRisk":197}],"term":"Influenza"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":210},{"groupId":"EG001","numAffected":12,"numAtRisk":197}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":210},{"groupId":"EG001","numAffected":12,"numAtRisk":197}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":210},{"groupId":"EG001","numAffected":10,"numAtRisk":197}],"term":"Hypoaesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":210},{"groupId":"EG001","numAffected":11,"numAtRisk":197}],"term":"Anxiety"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":210},{"groupId":"EG001","numAffected":11,"numAtRisk":197}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Neutropenic sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Lower respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":3,"numAtRisk":197}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Bacterial prostatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Creutzfeldt-Jakob disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Empyema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Gastroenteritis norovirus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Giardiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Meningitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Otitis externa"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Pneumonia mycoplasmal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Postoperative wound infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Urinary tract infection bacterial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":210},{"groupId":"EG001","numAffected":12,"numAtRisk":197}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":210},{"groupId":"EG001","numAffected":6,"numAtRisk":197}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Oral lichen planus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Colitis ulcerative"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Duodenal ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Enteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Ileus paralytic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Mouth ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Proctalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Acute respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":210},{"groupId":"EG001","numAffected":6,"numAtRisk":197}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Multi-organ failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Acute coronary syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Acute myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Cardiac failure congestive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Myocardial ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Stress fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Ankle fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Femoral neck fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Foreign body"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Multiple injuries"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Skull fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Osteoarthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Flank pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Pathological fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Coma hepatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Hydrocephalus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Migraine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Paraesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Sciatica"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Basal cell carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Prostate cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Rectal adenocarcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Squamous cell carcinoma of lung"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Squamous cell carcinoma of skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Thyroid cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Tumour lysis syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Hyperhidrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Lichen planus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Skin ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Arterial occlusive disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Hypertensive crisis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Vena cava thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Eastern Cooperative Oncology Group performance status worsened"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"International normalised ratio increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Hydronephrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Urinary retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Vertigo"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Cholangitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (16.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Cholecystitis acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Major depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Pelvic cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Mesenteric vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Abdominal wall haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Large intestine polyp"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Jaundice"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Appendicitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":2,"numAtRisk":197}],"term":"Urosepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Chronic hepatitis B"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Erysipelas"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Hepatitis viral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Intestinal sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Pulmonary tuberculosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Pyelonephritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Respiratory tract infection fungal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Lumbar vertebral fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Procedural pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Traumatic intracranial haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Wrist fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Adenocarcinoma of colon"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Cervix Carcinoma Stage 0"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Colon cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Kaposi's sarcoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Lung neoplasm malignant"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Myelodysplastic syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Renal cell carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Uterine leiomyoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Cognitive disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Hypoglycaemic coma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Transient ischaemic attack"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Bipolar disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Ovarian cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Uterovaginal prolapse"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Bronchitis chronic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Subclavian artery occlusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Bladder calculus removal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Hysterectomy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Calculus bladder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Uterine polyp"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Cellulitis gangrenous"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":210},{"groupId":"EG001","numAffected":0,"numAtRisk":197}],"term":"Adenocarcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Breast cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Plasma cell myeloma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":210},{"groupId":"EG001","numAffected":1,"numAtRisk":197}],"term":"Squamous cell carcinoma"}],"timeFrame":"Baseline up to data cutoff date of 31 Oct 2017 (up to 6 years)"}