{"eventGroups":[{"description":"Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)","id":"EG000","otherNumAffected":16,"otherNumAtRisk":60,"seriousNumAffected":9,"seriousNumAtRisk":60,"title":"End-stage Kidney Disease With Secondary Hyperparathyroidism"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":60}],"term":"Calcium phosphate product increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":60}],"term":"Hypercalcaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":60}],"term":"Hyperphoshataemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Duodenal ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Gastric ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Arthritis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Arteriovenous fistula site complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Sacroiliitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Arterial occlusive disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Circulatory collapse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60}],"term":"Hypertension"}],"timeFrame":"Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®."}