{"description":"Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.","eventGroups":[{"description":"Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.","id":"EG000","otherNumAffected":50,"otherNumAtRisk":150,"seriousNumAffected":28,"seriousNumAtRisk":150,"title":"Mircera"},{"description":"Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.","id":"EG001","otherNumAffected":65,"otherNumAtRisk":155,"seriousNumAffected":39,"seriousNumAtRisk":155,"title":"Darbepoetin Alfa"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":150},{"groupId":"EG001","numAffected":37,"numAtRisk":155}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150},{"groupId":"EG001","numAffected":8,"numAtRisk":155}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":150},{"groupId":"EG001","numAffected":11,"numAtRisk":155}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150},{"groupId":"EG001","numAffected":8,"numAtRisk":155}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150},{"groupId":"EG001","numAffected":12,"numAtRisk":155}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":150},{"groupId":"EG001","numAffected":6,"numAtRisk":155}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":150},{"groupId":"EG001","numAffected":7,"numAtRisk":155}],"term":"Hyperkalaemia"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150},{"groupId":"EG001","numAffected":9,"numAtRisk":155}],"term":"Renal impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Azotaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Renal cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Renal failure acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Urinary retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Acute myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Cardiac failure congestive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Myocardial ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Atrioventricular block complete"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Cardiac failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Cardiac failure acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Cardio-respiratory arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Cardiogenic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Coronary artery disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Pericarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":5,"numAtRisk":155}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":2,"numAtRisk":155}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Diabetic gangrene"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Meningoencephalitis bacterial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Osteomyelitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Pulmonary sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Septic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":2,"numAtRisk":155}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Hypoglycaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Starvation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":2,"numAtRisk":155}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Gastritis haemorrhagic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Haemorrhoidal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Intestinal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Arteriovenous fistula thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Dislocation of joint prosthesis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Implantable defibrillator malfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Laceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Medical device complication"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Post procedural haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Spinal compression fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Upper limb fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Renal neoplasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Chronic lymphocytic leukaemia recurrent"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Penis carcinoma metatstatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Prostatic adenoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Renal cancer metastatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Dementia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Ischaemic 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(12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Pneumonia aspiration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Pulmonary 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(12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Peripheral arterial occlusive disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":155}],"term":"Nephrogenic anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Sudden 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(12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":155}],"term":"Prostatitis"}],"timeFrame":"Baseline up to 29 weeks"}