{"description":"Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as 'ongoing.'","eventGroups":[{"description":"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle\n\nNetupitant and Palonosetron\n\nDexamethasone","id":"EG000","otherNumAffected":265,"otherNumAtRisk":308,"seriousNumAffected":50,"seriousNumAtRisk":308,"title":"Netupitant and Palonosetron Plus Dexamethasone"},{"description":"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.\n\nAprepitant\n\nPalonosetron\n\nDexamethasone","id":"EG001","otherNumAffected":95,"otherNumAtRisk":104,"seriousNumAffected":19,"seriousNumAtRisk":104,"title":"Aprepitant and Palonosetron Plus Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":308},{"groupId":"EG001","numAffected":26,"numAtRisk":104}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":308},{"groupId":"EG001","numAffected":18,"numAtRisk":104}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":95,"numAtRisk":308},{"groupId":"EG001","numAffected":29,"numAtRisk":104}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":308},{"groupId":"EG001","numAffected":16,"numAtRisk":104}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":308},{"groupId":"EG001","numAffected":9,"numAtRisk":104}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":308},{"groupId":"EG001","numAffected":19,"numAtRisk":104}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":308},{"groupId":"EG001","numAffected":3,"numAtRisk":104}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":308},{"groupId":"EG001","numAffected":11,"numAtRisk":104}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":308},{"groupId":"EG001","numAffected":6,"numAtRisk":104}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":308},{"groupId":"EG001","numAffected":12,"numAtRisk":104}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":308},{"groupId":"EG001","numAffected":15,"numAtRisk":104}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":308},{"groupId":"EG001","numAffected":10,"numAtRisk":104}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":308},{"groupId":"EG001","numAffected":6,"numAtRisk":104}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":308},{"groupId":"EG001","numAffected":4,"numAtRisk":104}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":308},{"groupId":"EG001","numAffected":7,"numAtRisk":104}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":308},{"groupId":"EG001","numAffected":4,"numAtRisk":104}],"term":"Hypokalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":308},{"groupId":"EG001","numAffected":7,"numAtRisk":104}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":308},{"groupId":"EG001","numAffected":8,"numAtRisk":104}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":77,"numAtRisk":308},{"groupId":"EG001","numAffected":32,"numAtRisk":104}],"term":"Alopecia"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Agranulocytosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":308},{"groupId":"EG001","numAffected":3,"numAtRisk":104}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Pancytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Cardiopulmonary failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Long QT syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Myocardial ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Ventricular extrasystoles"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Diverticulum intestinal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Duodenal ulcer perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Gastric perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":2,"numAtRisk":104}],"term":"Ileus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Intestinal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":2,"numAtRisk":104}],"term":"Peritonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Subileus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Device dislocation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Multi-organ failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Drug hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Catheter site infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Diverticulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Lower respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Otitis media"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Urinary tract infection pseudomonal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Femur fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Radiation mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Radiation oesophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Acidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Diabetic ketoacidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Electrolyte imbalance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Bronchial carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Metastases to bone"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Neoplasm malignant"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Neoplasm progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Renal cancer recurrent"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Cerebral ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Convulsion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Ischaemic stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Acute psychosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Confusional state"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Dysuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":2,"numAtRisk":104}],"term":"Renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Renal failure acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Haemoptysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Hiccups"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Chemotherapy extravasation management"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":308},{"groupId":"EG001","numAffected":0,"numAtRisk":104}],"term":"Hypertensive crisis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":308},{"groupId":"EG001","numAffected":1,"numAtRisk":104}],"term":"Peripheral ischaemia"}],"timeFrame":"The reporting period for AEs was the period starting from the time of informed consent signature until 21 (+2) days post study drug administration (Day 1 of last cycle)."}