{"description":"The enrolled and randomised population was Vandetanib 14 \\& Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 \\& Vinorelbine 10)","eventGroups":[{"description":"Vandetanib 300 mg/day oral","id":"EG000","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":6,"seriousNumAtRisk":13,"title":"Vandetanib"},{"description":"Vinorelbine 30 mg/m2 iv, administrated weekly","id":"EG001","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":3,"seriousNumAtRisk":10,"title":"Vinorelbine"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":10}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Ear Discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13},{"groupId":"EG001","numAffected":6,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":10}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Abdominal Distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Anal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Oral Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Rectal Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":13},{"groupId":"EG001","numAffected":6,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":10}],"term":"Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"General Physical Health Deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Mucosal Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Orthostatic Intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":10}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Gastrointestinal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":8,"numAtRisk":10}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":3,"numAtRisk":10}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"White Blood Cell Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Blood Alkaline Phosphatase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Liver Function Test Abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":13},{"groupId":"EG001","numAffected":4,"numAtRisk":10}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Diabetes Mellitus Insulin-Dependent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Musculoskeletal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Pain In Jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Tumour Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":4,"numAtRisk":10}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Mental Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Sleep Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Oliguria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Benign Prostatic Hyperplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Night Sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Hot Flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Phlebitis"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Venous stasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Acute Abdomen"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Gastrointestinal Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Febrile Neutropoenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Inguinal Hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Deterioration Of General Health"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Angina Pectoris"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Pulmonary Embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Papilloedema"}]}