{"description":"Safety population included all participants who received at least one dose of study drug and had a safety follow-up visit.","eventGroups":[{"description":"Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.","id":"EG000","otherNumAffected":11,"otherNumAtRisk":16,"seriousNumAffected":4,"seriousNumAtRisk":16,"title":"MIRCERA Group 1: Intermediate-Conversion-Factor Group"},{"description":"Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.","id":"EG001","otherNumAffected":28,"otherNumAtRisk":48,"seriousNumAffected":17,"seriousNumAtRisk":48,"title":"MIRCERA Group 2: High-Conversion-Factor Group"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":14,"numAtRisk":48}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"H1N1 influenza"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Conjunctivitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Oral herpes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":13,"numAtRisk":48}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Paraesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16},{"groupId":"EG001","numAffected":5,"numAtRisk":48}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":9,"numAtRisk":48}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Hyperphosphataemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":4,"numAtRisk":48}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":48}],"term":"Oropharyngeal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":4,"numAtRisk":48}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Ear pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Vertigo"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Hyperparathyroidism secondary"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Contusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Haemoglobin decreased"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Device related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Orchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Pharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Staphylococcal scalded skin syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":48}],"term":"Arteriovenous fistula thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":48}],"term":"Procedural haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Arterial injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Transplant failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":48}],"term":"Thrombosis in device"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Device dislocation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General 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pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":48}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Fluid overload"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Pericarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Intracranial haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Lupus nephritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":48}],"term":"Uterine haemorrhage"}],"timeFrame":"Baseline up to Week 73"}