{"description":"Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.","eventGroups":[{"deathsNumAffected":73,"deathsNumAtRisk":268,"description":"Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"EG000","otherNumAffected":248,"otherNumAtRisk":264,"seriousNumAffected":152,"seriousNumAtRisk":264,"title":"Isa-IV + Pd"},{"deathsNumAffected":77,"deathsNumAtRisk":263,"description":"Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"EG001","otherNumAffected":242,"otherNumAtRisk":263,"seriousNumAffected":160,"seriousNumAtRisk":263,"title":"Isa-SC + Pd"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":264,"numEvents":37},{"groupId":"EG001","numAffected":26,"numAtRisk":263,"numEvents":34}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":264,"numEvents":38},{"groupId":"EG001","numAffected":32,"numAtRisk":263,"numEvents":34}],"term":"Covid-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":264,"numEvents":12},{"groupId":"EG001","numAffected":23,"numAtRisk":263,"numEvents":23}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":264,"numEvents":36},{"groupId":"EG001","numAffected":21,"numAtRisk":263,"numEvents":28}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":264,"numEvents":43},{"groupId":"EG001","numAffected":19,"numAtRisk":263,"numEvents":21}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":264,"numEvents":15},{"groupId":"EG001","numAffected":12,"numAtRisk":263,"numEvents":14}],"term":"Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":264,"numEvents":145},{"groupId":"EG001","numAffected":74,"numAtRisk":263,"numEvents":165}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":264,"numEvents":25},{"groupId":"EG001","numAffected":15,"numAtRisk":263,"numEvents":16}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":264,"numEvents":8},{"groupId":"EG001","numAffected":14,"numAtRisk":263,"numEvents":16}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":264,"numEvents":204},{"groupId":"EG001","numAffected":93,"numAtRisk":263,"numEvents":218}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":264,"numEvents":25},{"groupId":"EG001","numAffected":17,"numAtRisk":263,"numEvents":19}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":264,"numEvents":9},{"groupId":"EG001","numAffected":15,"numAtRisk":263,"numEvents":19}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":264,"numEvents":68},{"groupId":"EG001","numAffected":46,"numAtRisk":263,"numEvents":54}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":264,"numEvents":20},{"groupId":"EG001","numAffected":21,"numAtRisk":263,"numEvents":24}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":264,"numEvents":25},{"groupId":"EG001","numAffected":16,"numAtRisk":263,"numEvents":18}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":264,"numEvents":30},{"groupId":"EG001","numAffected":19,"numAtRisk":263,"numEvents":21}],"term":"Peripheral Sensory Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":264,"numEvents":18},{"groupId":"EG001","numAffected":9,"numAtRisk":263,"numEvents":9}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":264,"numEvents":13},{"groupId":"EG001","numAffected":15,"numAtRisk":263,"numEvents":17}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":264,"numEvents":36},{"groupId":"EG001","numAffected":24,"numAtRisk":263,"numEvents":31}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":264,"numEvents":18},{"groupId":"EG001","numAffected":17,"numAtRisk":263,"numEvents":17}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":264,"numEvents":8},{"groupId":"EG001","numAffected":16,"numAtRisk":263,"numEvents":21}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":264,"numEvents":50},{"groupId":"EG001","numAffected":39,"numAtRisk":263,"numEvents":45}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":264,"numEvents":107},{"groupId":"EG001","numAffected":60,"numAtRisk":263,"numEvents":84}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":264,"numEvents":32},{"groupId":"EG001","numAffected":20,"numAtRisk":263,"numEvents":24}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":264,"numEvents":17},{"groupId":"EG001","numAffected":15,"numAtRisk":263,"numEvents":21}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":264,"numEvents":18},{"groupId":"EG001","numAffected":14,"numAtRisk":263,"numEvents":14}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":264,"numEvents":21},{"groupId":"EG001","numAffected":16,"numAtRisk":263,"numEvents":18}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":264,"numEvents":35},{"groupId":"EG001","numAffected":32,"numAtRisk":263,"numEvents":35}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":264,"numEvents":39},{"groupId":"EG001","numAffected":21,"numAtRisk":263,"numEvents":26}],"term":"Muscle Spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":264,"numEvents":16},{"groupId":"EG001","numAffected":11,"numAtRisk":263,"numEvents":12}],"term":"Muscular Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":264,"numEvents":18},{"groupId":"EG001","numAffected":8,"numAtRisk":263,"numEvents":10}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":264,"numEvents":31},{"groupId":"EG001","numAffected":25,"numAtRisk":263,"numEvents":29}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":264,"numEvents":52},{"groupId":"EG001","numAffected":57,"numAtRisk":263,"numEvents":66}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":264,"numEvents":24},{"groupId":"EG001","numAffected":18,"numAtRisk":263,"numEvents":28}],"term":"Influenza Like Illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":264,"numEvents":50},{"groupId":"EG001","numAffected":33,"numAtRisk":263,"numEvents":42}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":264,"numEvents":27},{"groupId":"EG001","numAffected":17,"numAtRisk":263,"numEvents":24}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":264,"numEvents":64},{"groupId":"EG001","numAffected":48,"numAtRisk":263,"numEvents":77}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":264,"numEvents":68},{"groupId":"EG001","numAffected":6,"numAtRisk":263,"numEvents":15}],"term":"Infusion Related Reaction"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Bronchopulmonary Aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Bullous Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":264,"numEvents":7},{"groupId":"EG001","numAffected":11,"numAtRisk":263,"numEvents":11}],"term":"Covid-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":264,"numEvents":6},{"groupId":"EG001","numAffected":7,"numAtRisk":263,"numEvents":7}],"term":"Covid-19 Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Campylobacter Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Campylobacter Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Clostridium Difficile Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Coronavirus Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Cryptococcal Fungaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cryptosporidiosis Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cytomegalovirus Chorioretinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Dengue Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Device Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Diarrhoea Infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Disseminated Cryptococcosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Encephalitis Cytomegalovirus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Gastroenteritis Escherichia Coli"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Gastroenteritis Salmonella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Gastrointestinal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Haematological Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Herpes Zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Herpes Zoster Disseminated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Infective Exacerbation Of Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Infective Exacerbation Of Chronic Obstructive Airways Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":264,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":263,"numEvents":4}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Intestinal Tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Listeria Encephalitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Liver Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Localised Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":263,"numEvents":5}],"term":"Lower Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Lower Respiratory Tract Infection Viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Ludwig Angina"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Meningitis Cryptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Meningitis Listeria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Meningococcal Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Metapneumovirus Bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Metapneumovirus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Metapneumovirus Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Neutropenic Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Orchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Parainfluenzae Virus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Pertussis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":264,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Pneumocystis Jirovecii Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":264,"numEvents":61},{"groupId":"EG001","numAffected":54,"numAtRisk":263,"numEvents":60}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Pneumonia Acinetobacter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pneumonia Adenoviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":2}],"term":"Pneumonia Bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Pneumonia Cytomegaloviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Pneumonia Escherichia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pneumonia Haemophilus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":264,"numEvents":6},{"groupId":"EG001","numAffected":5,"numAtRisk":263,"numEvents":5}],"term":"Pneumonia Influenzal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pneumonia Legionella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Pneumonia Parainfluenzae Viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pneumonia Pneumococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Pneumonia Pseudomonal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Pneumonia Respiratory Syncytial Viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pneumonia Viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Postoperative Wound Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pulmonary Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":2}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Respiratory Syncytial Virus Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Respiratory Syncytial Virus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Respiratory Tract Infection Bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Respiratory Tract Infection Viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Rhinovirus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Scabies"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":263,"numEvents":4}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Septic Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Skin Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Soft Tissue Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Staphylococcal Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Staphylococcal Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Upper Respiratory Fungal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":264,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":263,"numEvents":7}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Viral Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Wound Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Wound Infection Staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Adenocarcinoma Of Colon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Adrenal Adenoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Breast Cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cancer Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Endometrial Adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Invasive Breast Carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Leptomeningeal Myelomatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Lung Adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Myelodysplastic Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Papillary Thyroid Cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Plasma Cell Leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Plasma Cell Myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Plasmacytoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Squamous Cell Carcinoma Of Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":264,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":263,"numEvents":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Disseminated Intravascular Coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":264,"numEvents":6},{"groupId":"EG001","numAffected":9,"numAtRisk":263,"numEvents":9}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Myelosuppression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":264,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":3}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cytokine Release Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Adrenal Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Hypercalcaemia Of Malignancy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":4}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":2}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Confusional State"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Drug Abuse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cerebral Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Cerebrovascular Accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cluster Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Haemorrhagic Stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Ischaemic Stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Paraparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Peripheral Sensorimotor Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Posterior Reversible Encephalopathy Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Putamen Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Sciatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Spinal Cord Compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Toxic Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":2}],"term":"Trigeminal Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Vocal Cord Paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cataract Cortical"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cataract Nuclear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Cataract Subcapsular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Acute Left Ventricular Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Angina Pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Arteriosclerosis Coronary Artery"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":264,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Atrial Flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Cardiac Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cardiac Failure Congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Cardio-Respiratory Arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Myocardial Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Sinus Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Acute Aortic Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Deep Vein Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Orthostatic Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Acute Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Chronic Obstructive Pulmonary Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Interstitial Lung Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pulmonary Congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":263,"numEvents":4}],"term":"Pulmonary Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":4}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Diverticular Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Diverticulum Intestinal Haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Gastrointestinal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Inguinal Hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Large Intestine Perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Oesophageal Ulcer Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Rectal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Upper Gastrointestinal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Cholecystitis Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Hepatitis Fulminant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Ischaemic Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Liver Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Scar Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Skin Ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Arthritis Reactive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Haematoma Muscle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Muscular Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Musculoskeletal Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Osteolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Osteonecrosis Of Jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":264,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Pathological Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Spondylitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":8,"numAtRisk":263,"numEvents":8}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":264,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":263,"numEvents":3}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":264,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":263,"numEvents":4}],"term":"Disease Progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"General Physical Health Deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Influenza Like Illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":263,"numEvents":4}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Sudden Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Blood Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Blood Potassium Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":264,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":263,"numEvents":4}],"term":"Platelet Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Compression Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Craniocerebral Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":263,"numEvents":2}],"term":"Femoral Neck Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Foot Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":264,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Infusion Related Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Intentional Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":264,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":263,"numEvents":0}],"term":"Pelvic Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Skin Laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 28.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":264,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":263,"numEvents":1}],"term":"Toxicity To Various Agents"}],"timeFrame":"Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 38 months. Partial results are presented up to DCO date of 29-Aug-2025."}