{"description":"All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly","eventGroups":[{"deathsNumAffected":236,"deathsNumAtRisk":304,"description":"Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles","id":"EG000","otherNumAffected":296,"otherNumAtRisk":304,"seriousNumAffected":158,"seriousNumAtRisk":304,"title":"Necitumumab+Pemetrexed+Cisplatin"},{"deathsNumAffected":246,"deathsNumAtRisk":312,"description":"Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles","id":"EG001","otherNumAffected":303,"otherNumAtRisk":312,"seriousNumAffected":130,"seriousNumAtRisk":312,"title":"Pemetrexed+Cisplatin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":304,"numEvents":155},{"groupId":"EG001","numAffected":91,"numAtRisk":312,"numEvents":200}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":304,"numEvents":92},{"groupId":"EG001","numAffected":36,"numAtRisk":312,"numEvents":61}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":304,"numEvents":53},{"groupId":"EG001","numAffected":17,"numAtRisk":312,"numEvents":26}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":92,"numAtRisk":304,"numEvents":179},{"groupId":"EG001","numAffected":99,"numAtRisk":312,"numEvents":217}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":304,"numEvents":43},{"groupId":"EG001","numAffected":23,"numAtRisk":312,"numEvents":42}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":304,"numEvents":18},{"groupId":"EG001","numAffected":16,"numAtRisk":312,"numEvents":18}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":304,"numEvents":46},{"groupId":"EG001","numAffected":6,"numAtRisk":312,"numEvents":6}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":304,"numEvents":4},{"groupId":"EG001","numAffected":17,"numAtRisk":312,"numEvents":17}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":304,"numEvents":25},{"groupId":"EG001","numAffected":15,"numAtRisk":312,"numEvents":15}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":304,"numEvents":36},{"groupId":"EG001","numAffected":25,"numAtRisk":312,"numEvents":29}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":91,"numAtRisk":304,"numEvents":133},{"groupId":"EG001","numAffected":83,"numAtRisk":312,"numEvents":124}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":90,"numAtRisk":304,"numEvents":148},{"groupId":"EG001","numAffected":51,"numAtRisk":312,"numEvents":78}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":304,"numEvents":21},{"groupId":"EG001","numAffected":18,"numAtRisk":312,"numEvents":28}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":174,"numAtRisk":304,"numEvents":392},{"groupId":"EG001","numAffected":183,"numAtRisk":312,"numEvents":403}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":304,"numEvents":41},{"groupId":"EG001","numAffected":12,"numAtRisk":312,"numEvents":22}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":105,"numAtRisk":304,"numEvents":213},{"groupId":"EG001","numAffected":104,"numAtRisk":312,"numEvents":180}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":304,"numEvents":192},{"groupId":"EG001","numAffected":68,"numAtRisk":312,"numEvents":146}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":87,"numAtRisk":304,"numEvents":164},{"groupId":"EG001","numAffected":95,"numAtRisk":312,"numEvents":171}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":304,"numEvents":104},{"groupId":"EG001","numAffected":27,"numAtRisk":312,"numEvents":36}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":304,"numEvents":16},{"groupId":"EG001","numAffected":16,"numAtRisk":312,"numEvents":22}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":304,"numEvents":52},{"groupId":"EG001","numAffected":41,"numAtRisk":312,"numEvents":51}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":304,"numEvents":57},{"groupId":"EG001","numAffected":22,"numAtRisk":312,"numEvents":32}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":304,"numEvents":22},{"groupId":"EG001","numAffected":5,"numAtRisk":312,"numEvents":5}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":304,"numEvents":67},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":304,"numEvents":21},{"groupId":"EG001","numAffected":16,"numAtRisk":312,"numEvents":21}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":304,"numEvents":34},{"groupId":"EG001","numAffected":18,"numAtRisk":312,"numEvents":23}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":304,"numEvents":53},{"groupId":"EG001","numAffected":24,"numAtRisk":312,"numEvents":28}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":110,"numAtRisk":304,"numEvents":174},{"groupId":"EG001","numAffected":97,"numAtRisk":312,"numEvents":171}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":304,"numEvents":39},{"groupId":"EG001","numAffected":12,"numAtRisk":312,"numEvents":22}],"term":"Fluid retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":304,"numEvents":34},{"groupId":"EG001","numAffected":10,"numAtRisk":312,"numEvents":15}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":304,"numEvents":51},{"groupId":"EG001","numAffected":13,"numAtRisk":312,"numEvents":16}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":304,"numEvents":34},{"groupId":"EG001","numAffected":23,"numAtRisk":312,"numEvents":33}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":75,"numAtRisk":304,"numEvents":185},{"groupId":"EG001","numAffected":36,"numAtRisk":312,"numEvents":66}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":304,"numEvents":36},{"groupId":"EG001","numAffected":20,"numAtRisk":312,"numEvents":30}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":304,"numEvents":40},{"groupId":"EG001","numAffected":20,"numAtRisk":312,"numEvents":24}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":304,"numEvents":26},{"groupId":"EG001","numAffected":15,"numAtRisk":312,"numEvents":21}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":304,"numEvents":22},{"groupId":"EG001","numAffected":17,"numAtRisk":312,"numEvents":19}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":304,"numEvents":52},{"groupId":"EG001","numAffected":26,"numAtRisk":312,"numEvents":37}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":304,"numEvents":27},{"groupId":"EG001","numAffected":32,"numAtRisk":312,"numEvents":43}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":304,"numEvents":41},{"groupId":"EG001","numAffected":27,"numAtRisk":312,"numEvents":32}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":304,"numEvents":20},{"groupId":"EG001","numAffected":8,"numAtRisk":312,"numEvents":9}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":304,"numEvents":20},{"groupId":"EG001","numAffected":10,"numAtRisk":312,"numEvents":11}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":304,"numEvents":23},{"groupId":"EG001","numAffected":15,"numAtRisk":312,"numEvents":20}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":304,"numEvents":75},{"groupId":"EG001","numAffected":48,"numAtRisk":312,"numEvents":59}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":304,"numEvents":62},{"groupId":"EG001","numAffected":41,"numAtRisk":312,"numEvents":52}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":304,"numEvents":30},{"groupId":"EG001","numAffected":9,"numAtRisk":312,"numEvents":9}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":304,"numEvents":30},{"groupId":"EG001","numAffected":10,"numAtRisk":312,"numEvents":12}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":304,"numEvents":17},{"groupId":"EG001","numAffected":7,"numAtRisk":312,"numEvents":9}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":304,"numEvents":31},{"groupId":"EG001","numAffected":18,"numAtRisk":312,"numEvents":20}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":304,"numEvents":119},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":304,"numEvents":62},{"groupId":"EG001","numAffected":11,"numAtRisk":312,"numEvents":13}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":95,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":107,"numEvents":0}],"term":"Hirsutism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":304,"numEvents":48},{"groupId":"EG001","numAffected":8,"numAtRisk":312,"numEvents":9}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":125,"numAtRisk":304,"numEvents":346},{"groupId":"EG001","numAffected":20,"numAtRisk":312,"numEvents":23}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":304,"numEvents":62},{"groupId":"EG001","numAffected":5,"numAtRisk":312,"numEvents":5}],"term":"Rash generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":304,"numEvents":24},{"groupId":"EG001","numAffected":29,"numAtRisk":312,"numEvents":41}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":304,"numEvents":15},{"groupId":"EG001","numAffected":13,"numAtRisk":312,"numEvents":18}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Granulocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":304,"numEvents":5},{"groupId":"EG001","numAffected":8,"numAtRisk":312,"numEvents":8}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":304,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":312,"numEvents":5}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Splenic infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":304,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":312,"numEvents":6}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Arrhythmia supraventricular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cardiac tamponade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":304,"numEvents":11},{"groupId":"EG001","numAffected":5,"numAtRisk":312,"numEvents":5}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Duodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Duodenal ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Ileus paralytic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Intestinal infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Intra-abdominal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":304,"numEvents":12},{"groupId":"EG001","numAffected":6,"numAtRisk":312,"numEvents":6}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Oesophageal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Pneumatosis intestinalis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":312,"numEvents":4}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Volvulus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":304,"numEvents":10},{"groupId":"EG001","numAffected":7,"numAtRisk":312,"numEvents":7}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":304,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":3}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":304,"numEvents":10},{"groupId":"EG001","numAffected":7,"numAtRisk":312,"numEvents":7}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":304,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":312,"numEvents":5}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":304,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Performance status decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":304,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Systemic inflammatory response syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Biliary colic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Gastrointestinal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Hepatitis b"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Herpes dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Herpes oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Intestinal gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":2}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Peritoneal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":304,"numEvents":14},{"groupId":"EG001","numAffected":6,"numAtRisk":312,"numEvents":7}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":312,"numEvents":3}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":304,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Skin bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Drug administration error"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Incorrect dose administered"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Lumbar vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":304,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Medication error"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Suture rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"International normalised ratio increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":304,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":312,"numEvents":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cachexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":304,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":312,"numEvents":8}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Fluid retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Malignant pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":304,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Metastatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":304,"numEvents":24},{"groupId":"EG001","numAffected":10,"numAtRisk":312,"numEvents":10}],"term":"Non-small cell lung cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":312,"numEvents":5}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":304,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Dizziness postural"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Hypotonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":2}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Nephropathy toxic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":304,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":312,"numEvents":7}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":304,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Acute pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":304,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":312,"numEvents":8}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":2}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":312,"numEvents":3}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Pulmonary artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":304,"numEvents":13},{"groupId":"EG001","numAffected":11,"numAtRisk":312,"numEvents":11}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":304,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":304,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Toxic skin eruption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Analgesic therapy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Aortic aneurysm rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Arterial stenosis limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Arterial thrombosis limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":312,"numEvents":2}],"term":"Circulatory collapse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":304,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Peripheral embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Peripheral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Poor venous access"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":304,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Subclavian vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":304,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Superior vena caval occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":312,"numEvents":1}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":304,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":312,"numEvents":0}],"term":"Venous thrombosis limb"}]}