{"description":"A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Adverse Events were assessed in the Safety Analysis Set at data cut-off date of 30 Jun 2022. All-Cause Mortality was analyzed in the Full Analysis Set. Serious and Other Adverse Events were analyzed in the Safety Analysis Set.","eventGroups":[{"deathsNumAffected":143,"deathsNumAtRisk":406,"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).","id":"EG000","otherNumAffected":398,"otherNumAtRisk":404,"seriousNumAffected":103,"seriousNumAtRisk":404,"title":"Trastuzumab Deruxtecan (T-DXd)"},{"deathsNumAffected":40,"deathsNumAtRisk":91,"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.","id":"EG001","otherNumAffected":79,"otherNumAtRisk":87,"seriousNumAffected":19,"seriousNumAtRisk":87,"title":"Trastuzumab+Capecitabine"},{"deathsNumAffected":46,"deathsNumAtRisk":111,"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.","id":"EG002","otherNumAffected":102,"otherNumAtRisk":108,"seriousNumAffected":27,"seriousNumAtRisk":108,"title":"Lapatinib+Capecitabine"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":114,"numAtRisk":404},{"groupId":"EG001","numAffected":13,"numAtRisk":87},{"groupId":"EG002","numAffected":13,"numAtRisk":108}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":6,"numAtRisk":108}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":7,"numAtRisk":108}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":404},{"groupId":"EG001","numAffected":2,"numAtRisk":87},{"groupId":"EG002","numAffected":2,"numAtRisk":108}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":5,"numAtRisk":108}],"term":"Dry Eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":292,"numAtRisk":404},{"groupId":"EG001","numAffected":29,"numAtRisk":87},{"groupId":"EG002","numAffected":44,"numAtRisk":108}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":150,"numAtRisk":404},{"groupId":"EG001","numAffected":9,"numAtRisk":87},{"groupId":"EG002","numAffected":14,"numAtRisk":108}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":142,"numAtRisk":404},{"groupId":"EG001","numAffected":12,"numAtRisk":87},{"groupId":"EG002","numAffected":9,"numAtRisk":108}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":109,"numAtRisk":404},{"groupId":"EG001","numAffected":33,"numAtRisk":87},{"groupId":"EG002","numAffected":69,"numAtRisk":108}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":404},{"groupId":"EG001","numAffected":6,"numAtRisk":87},{"groupId":"EG002","numAffected":12,"numAtRisk":108}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":404},{"groupId":"EG001","numAffected":7,"numAtRisk":87},{"groupId":"EG002","numAffected":11,"numAtRisk":108}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":404},{"groupId":"EG001","numAffected":11,"numAtRisk":87},{"groupId":"EG002","numAffected":25,"numAtRisk":108}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":404},{"groupId":"EG001","numAffected":7,"numAtRisk":87},{"groupId":"EG002","numAffected":11,"numAtRisk":108}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":144,"numAtRisk":404},{"groupId":"EG001","numAffected":20,"numAtRisk":87},{"groupId":"EG002","numAffected":32,"numAtRisk":108}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":97,"numAtRisk":404},{"groupId":"EG001","numAffected":6,"numAtRisk":87},{"groupId":"EG002","numAffected":13,"numAtRisk":108}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":404},{"groupId":"EG001","numAffected":5,"numAtRisk":87},{"groupId":"EG002","numAffected":7,"numAtRisk":108}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":5,"numAtRisk":108}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":404},{"groupId":"EG001","numAffected":6,"numAtRisk":87},{"groupId":"EG002","numAffected":9,"numAtRisk":108}],"term":"Mucosal Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":2,"numAtRisk":108}],"term":"Covid-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":3,"numAtRisk":108}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":2,"numAtRisk":108}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":3,"numAtRisk":108}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":11,"numAtRisk":108}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":404},{"groupId":"EG001","numAffected":7,"numAtRisk":87},{"groupId":"EG002","numAffected":7,"numAtRisk":108}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":404},{"groupId":"EG001","numAffected":2,"numAtRisk":87},{"groupId":"EG002","numAffected":5,"numAtRisk":108}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":404},{"groupId":"EG001","numAffected":5,"numAtRisk":87},{"groupId":"EG002","numAffected":18,"numAtRisk":108}],"term":"Aspartate Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":404},{"groupId":"EG001","numAffected":6,"numAtRisk":87},{"groupId":"EG002","numAffected":14,"numAtRisk":108}],"term":"Alanine Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":404},{"groupId":"EG001","numAffected":5,"numAtRisk":87},{"groupId":"EG002","numAffected":4,"numAtRisk":108}],"term":"White Blood Cell Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":404},{"groupId":"EG001","numAffected":5,"numAtRisk":87},{"groupId":"EG002","numAffected":7,"numAtRisk":108}],"term":"Platelet Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":404},{"groupId":"EG001","numAffected":2,"numAtRisk":87},{"groupId":"EG002","numAffected":2,"numAtRisk":108}],"term":"Lymphocyte Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":4,"numAtRisk":108}],"term":"Blood Alkaline Phosphatase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":17,"numAtRisk":108}],"term":"Blood Bilirubin Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":404},{"groupId":"EG001","numAffected":15,"numAtRisk":87},{"groupId":"EG002","numAffected":20,"numAtRisk":108}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":404},{"groupId":"EG001","numAffected":7,"numAtRisk":87},{"groupId":"EG002","numAffected":6,"numAtRisk":108}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":404},{"groupId":"EG001","numAffected":7,"numAtRisk":87},{"groupId":"EG002","numAffected":7,"numAtRisk":108}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":5,"numAtRisk":108}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":4,"numAtRisk":108}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":4,"numAtRisk":108}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":7,"numAtRisk":108}],"term":"Muscle Spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":404},{"groupId":"EG001","numAffected":7,"numAtRisk":87},{"groupId":"EG002","numAffected":5,"numAtRisk":108}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":404},{"groupId":"EG001","numAffected":5,"numAtRisk":87},{"groupId":"EG002","numAffected":9,"numAtRisk":108}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":404},{"groupId":"EG001","numAffected":6,"numAtRisk":87},{"groupId":"EG002","numAffected":4,"numAtRisk":108}],"term":"Neuropathy Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":404},{"groupId":"EG001","numAffected":6,"numAtRisk":87},{"groupId":"EG002","numAffected":5,"numAtRisk":108}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":404},{"groupId":"EG001","numAffected":7,"numAtRisk":87},{"groupId":"EG002","numAffected":13,"numAtRisk":108}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":10,"numAtRisk":108}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":404},{"groupId":"EG001","numAffected":5,"numAtRisk":87},{"groupId":"EG002","numAffected":7,"numAtRisk":108}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":150,"numAtRisk":404},{"groupId":"EG001","numAffected":4,"numAtRisk":87},{"groupId":"EG002","numAffected":4,"numAtRisk":108}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":19,"numAtRisk":108}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":404},{"groupId":"EG001","numAffected":2,"numAtRisk":87},{"groupId":"EG002","numAffected":6,"numAtRisk":108}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":6,"numAtRisk":108}],"term":"Dry Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":404},{"groupId":"EG001","numAffected":48,"numAtRisk":87},{"groupId":"EG002","numAffected":52,"numAtRisk":108}],"term":"Palmar-Plantar Erythrodysaesthesia Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":404},{"groupId":"EG001","numAffected":2,"numAtRisk":87},{"groupId":"EG002","numAffected":6,"numAtRisk":108}],"term":"Rash Maculo-Papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":10,"numAtRisk":108}],"term":"Dermatitis Acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":6,"numAtRisk":108}],"term":"Skin Toxicity"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Haemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Stress Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Autoimmune Thyroiditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Autoimmune Thyroiditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Scleritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":404},{"groupId":"EG001","numAffected":2,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":404},{"groupId":"EG001","numAffected":2,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":3,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Duodenal Ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Gastrointestinal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Haemorrhoidal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Large Intestinal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Oesophageal Varices Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":3,"numAtRisk":108}],"term":"Disease Progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"General Physical Health Deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Covid-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Covid-19 Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Device Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pneumocystis Jirovecii Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Hepatitis B"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Mastitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Post Procedural Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Skin Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Wound Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Radiation Necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Head Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Hip Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Lumbar Vertebral Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Subdural Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Wrist Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Muscular Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Neck Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Osteonecrosis Of Jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Acute Myeloid Leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Malignant Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Metastases To Meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Metastases To Ovary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pulmonary Tumour Thrombotic Microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Brain Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Depressed Level Of Consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Generalised Tonic-Clonic Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Hemiplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Monoplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Vasogenic Cerebral Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Mental Status Changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Suicide Attempt"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Cystitis Haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Breast Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Interstitial Lung Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":3,"numAtRisk":108}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Laryngeal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Lung Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Pulmonary Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pulmonary Fibrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pulmonary Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Pulmonary Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Skin Hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Brachiocephalic Vein Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Deep Vein Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Orthostatic Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Abdominal Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Lower Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Neutropenic Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Accidental Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Cancer Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Cerebral Ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":1,"numAtRisk":87},{"groupId":"EG002","numAffected":0,"numAtRisk":108}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Acute Myocardial Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Cardiac Arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Cardiac Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Myocardial Ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Pericardial Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Gastric Antral Vascular Ectasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Peritonitis Bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Craniocerebral Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Hepatic Enzyme Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Pancreatic Enzymes Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Cancer Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Cerebral Ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Hypertensive Urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":404},{"groupId":"EG001","numAffected":0,"numAtRisk":87},{"groupId":"EG002","numAffected":1,"numAtRisk":108}],"term":"Peripheral Ischaemia"}],"timeFrame":"Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 46 months."}