Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-06-25 @ 8:03 PM
Study NCT ID:
NCT00994318
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2009-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005578', 'term': 'Fosfomycin'}, {'id': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D007501', 'term': 'Iron'}, {'id': 'C020748', 'term': 'ferrous sulfate'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@viforpharma.com', 'phone': '41 58 851 8222', 'title': 'Medical Information', 'organization': 'Vifor Pharma'}, 'certainAgreement': {'otherDetails': 'Investigators may not present or publish partial or complete study results individually. Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Initially 1,016 subjects were planned, but due to slow enrollment only 626 were randomised which was sufficient to make the primary comparison between FCM targeting high ferritin level and oral iron.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data was collected for 56 weeks after baseline.', 'description': 'The Number of Patients at Risk is the Safety Set which consists of all randomised subjects who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'FCM (High Ferritin Target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L', 'otherNumAtRisk': 154, 'otherNumAffected': 126, 'seriousNumAtRisk': 154, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'FCM (Low Ferritin Target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L', 'otherNumAtRisk': 150, 'otherNumAffected': 129, 'seriousNumAtRisk': 150, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Oral Iron', 'description': 'Ferrous sulphate 100 mg iron twice daily, continuous', 'otherNumAtRisk': 312, 'otherNumAffected': 255, 'seriousNumAtRisk': 312, 'seriousNumAffected': 59}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 32}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertensive Heart Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Left Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinus Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Infective Exacerbation of Chronic Obstructive Airways Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Infected Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Staphylococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wound Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wound Infection Staphlyococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal Failure Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nephrotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 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'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypoglycaemic Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypotonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Loss of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Orthostatic Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vertebrobasilar Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Circulatory Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nephrogenic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Device Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hernia Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetic Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'International Normalised Ratio Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FCM (High Ferritin Target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 400-600 mcg/L'}, {'id': 'OG001', 'title': 'FCM (Low Ferritin Level)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 100-200 mcg/L'}, {'id': 'OG002', 'title': 'Oral Iron', 'description': 'Ferrous sulphate 100 mg iron twice daily, continuous'}], 'classes': [{'title': 'Number of patients with events', 'categories': [{'measurements': [{'value': '36', 'spread': '7.65', 'groupId': 'OG000'}, {'value': '49', 'spread': '9.47', 'groupId': 'OG001', 'lowerLimit': '0.45', 'upperLimit': '1.05'}, {'value': '98', 'spread': '7.71', 'groupId': 'OG002', 'lowerLimit': '0.44', 'upperLimit': '0.95'}]}]}, {'title': 'Number of patients without events', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.95', 'groupDescription': 'FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).\n\nThree primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:\n\n1. FCM (high ferritin target) compared with oral iron.\n2. FCM (high ferritin target) compared with FCM (low ferritin target).\n3. FCM (low ferritin target) compared with oral iron.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.05', 'groupDescription': 'FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).\n\nThree primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:\n\n1. FCM (high ferritin target) compared with oral iron.\n2. FCM (high ferritin target) compared with FCM (low ferritin target).\n3. FCM (low ferritin target) compared with oral iron.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.93', 'groupDescription': 'Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.\n\nFCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.88', 'groupDescription': 'Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.\n\nFCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.12', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.10', 'groupDescription': 'Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.\n\nFCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year after baseline', 'description': 'Endpoint reported number of participants with/without events and was reached:\n\n* First time of initiation of additional or alternative anaemia management,\n* First time the subject reached the Hb trigger.\n\n 3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:\n 1. FCM (high ferritin target) compared with oral iron.\n 2. FCM (high ferritin target) compared with FCM (low ferritin target).\n 3. FCM (low ferritin target) compared with oral iron.\n\nSensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:\n\n1. Without taking into account the Hb trigger.\n2. Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.\n3. Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used for the primary endpoint analysis, which consisted of all subjects randomised to treatment, received at least 1 dose of study treatment or, according to the protocol, were not treated due to ferritin value \\<100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FCM (High Ferritin Target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L'}, {'id': 'FG001', 'title': 'FCM (Low Ferritin Target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L'}, {'id': 'FG002', 'title': 'Oral Iron', 'description': 'Ferrous sulphate 100 mg iron twice daily, continuous'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '317'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '67'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}, {'value': '613', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FCM (High Ferritin Target', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L'}, {'id': 'BG001', 'title': 'FCM (Low Ferritin Target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L'}, {'id': 'BG002', 'title': 'Oral Iron', 'description': 'Ferrous sulphate 100 mg iron twice daily, continuous'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '431', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.46', 'spread': '12.643', 'groupId': 'BG000'}, {'value': '68.19', 'spread': '13.264', 'groupId': 'BG001'}, {'value': '69.31', 'spread': '13.404', 'groupId': 'BG002'}, {'value': '69.07', 'spread': '13.172', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '381', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '584', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analysis population is the Full Analysis Set (FAS); all subjects randomised to treatment, received at least 1 dose study drug or, per protocol, not treated due to ferritin \\<100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment. Overall 626 subjects were randomised, the FAS consists of 613 subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 626}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-09', 'studyFirstSubmitDate': '2009-10-12', 'resultsFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger', 'timeFrame': 'Up to 1 year after baseline', 'description': 'Endpoint reported number of participants with/without events and was reached:\n\n* First time of initiation of additional or alternative anaemia management,\n* First time the subject reached the Hb trigger.\n\n 3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:\n 1. FCM (high ferritin target) compared with oral iron.\n 2. FCM (high ferritin target) compared with FCM (low ferritin target).\n 3. FCM (low ferritin target) compared with oral iron.\n\nSensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:\n\n1. Without taking into account the Hb trigger.\n2. Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.\n3. Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ferinject Iron Deficiency Anaemia Chronic Kidney Disease'], 'conditions': ['Iron Deficiency Anaemia', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '28339831', 'type': 'DERIVED', 'citation': 'Roger SD, Gaillard CA, Bock AH, Carrera F, Eckardt KU, Van Wyck DB, Cronin M, Meier Y, Larroque S, Macdougall IC; FIND-CKD Study Investigators. Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial. Nephrol Dial Transplant. 2017 Sep 1;32(9):1530-1539. doi: 10.1093/ndt/gfw264.'}, {'pmid': '28095881', 'type': 'DERIVED', 'citation': 'Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Meier Y, Larroque S, Roger SD; FIND-CKD Study investigators. Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial. BMC Nephrol. 2017 Jan 17;18(1):24. doi: 10.1186/s12882-017-0444-6.'}, {'pmid': '24891437', 'type': 'DERIVED', 'citation': 'Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).', 'detailedDescription': 'After an initial screening period of up to 4 weeks, eligible subjects were randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.\n\n1. FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L.\n2. FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L.\n3. Daily oral iron with 200 mg iron/day (100 mg twice daily)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age.\n2. NDD-CKD subjects with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m2 using modification of diet in renal disease 4 (MDRD-4) calculation.\n3. NDD-CKD subjects with an eGFR loss ≤12 mL/min/1.73 m2/year and a predicted eGFR of ≥15 mL/min/1.73 m2 in 12 months.\n4. Any single Hb between 9 and 11 g/dL within 4 weeks of randomisation. A value taken as part of routine medical care was used.\n5. Any single serum ferritin \\<100 mcg/L or \\<200 mcg/L with TSAT \\<20% within 4 weeks of randomisation. Measurements taken as part of routine medical care were used.\n6. ESA naïve; no exposure to ESA in last 4 months prior to randomisation.\n7. Females of childbearing potential must have had a negative pregnancy test, using any medically acceptable assessment, prior to randomisation.\n8. Before any study specific procedure, the appropriate written informed consent must have been obtained.\n\nExclusion Criteria:\n\n1. History of acquired iron overload.\n2. Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects with hypersensitivity to other forms of iron were permitted to participate.\n3. Documented history of discontinuing oral iron products due to significant gastrointestinal (GI) distress.\n4. Screening TSAT \\>40%.\n5. Known active infection, C-reactive protein \\>20 mg/L, clinically significant overt bleeding, active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia).\n6. History of chronic alcohol abuse (alcohol consumption \\>40 g/day).\n7. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.\n8. Active human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome or active hepatitis B or C virus infection.\n9. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with treated Vitamin B12 or folic acid deficiency were permitted.\n10. IV iron and/or blood transfusion in previous 30 days prior to screening (or during the screening period).\n11. Oral iron therapy at doses \\>100 mg/day dosing must have been discontinued at least 1 week prior to randomisation. If subject had received this therapy for \\>3 months (at doses \\>100 mg/day) then subject was not eligible. Ongoing use of multivitamins containing iron was permitted.\n12. Immunosuppressive therapy that may have led to anaemia (e.g., cyclophosphamide, azathioprine, or mycophenolate mofetil). Steroid therapy was permitted.\n13. Currently requiring renal dialysis.\n14. Anticipated dialysis or transplant during the study.\n15. Anticipated need for surgery that may have resulted in significant bleeding (\\>100 mL).\n16. Currently suffering from chronic heart failure New York Heart Association Class IV.\n17. Poorly controlled hypertension (\\>160 mmHg systolic pressure or \\>100 mmHg diastolic pressure).\n18. Acute coronary syndrome or stroke within the 3 months prior to screening.\n19. Currently suffering from concomitant, severe psychiatric disorders or other conditions which, in the opinion of the Investigator, would have made participation unacceptable.\n20. Subject was not using adequate contraceptive precautions.\n21. Subject of childbearing potential was evidently pregnant (e.g., positive human chorionic gonadotropin test) or was breast feeding.\n22. Body weight \\<35 kg.\n23. Subject currently was enrolled in or had not yet completed at least 30 days since ending other investigational device or drug studies, or subject was receiving other investigational agent(s).\n24. Subject would not be available for follow-up assessment.\n25. Subject had any kind of disorder that compromised the ability of the subject to give written informed consent and/or to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT00994318', 'acronym': 'FIND-CKD', 'briefTitle': 'Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'FER-CKD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FCM (high ferritin target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L', 'interventionNames': ['Drug: FCM (Ferric carboxymaltose) high ferritin target']}, {'type': 'EXPERIMENTAL', 'label': 'FCM (low ferritin target)', 'description': 'Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L', 'interventionNames': ['Drug: FCM (Ferric carboxymaltose) low ferritin target']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Iron', 'description': 'Ferrous sulphate 100 mg iron twice daily, continuous', 'interventionNames': ['Drug: Oral Iron (Ferrous sulphate)']}], 'interventions': [{'name': 'FCM (Ferric carboxymaltose) high ferritin target', 'type': 'DRUG', 'otherNames': ['Ferinject', 'Injectafer'], 'armGroupLabels': ['FCM (high ferritin target)']}, {'name': 'FCM (Ferric carboxymaltose) low ferritin target', 'type': 'DRUG', 'otherNames': ['Ferinject', 'Injectafer'], 'armGroupLabels': ['FCM (low ferritin target)']}, {'name': 'Oral Iron (Ferrous sulphate)', 'type': 'DRUG', 'otherNames': ['Ferrous sulphate'], 'armGroupLabels': ['Oral Iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Trial Management Associates', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '2250', 'city': 'Gosford', 'country': 'Australia', 'facility': 'Gosford Hospital - Renal Research', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin IV', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '7331', 'city': 'Baudour', 'country': 'Belgium', 'facility': 'RHMS Baudour - Department of Nephrology and Dialysis', 'geoPoint': {'lat': 50.48296, 'lon': 3.8332}}, {'zip': '74101', 'city': 'Nový Jičín', 'country': 'Czechia', 'facility': 'Nemocnice s poliklinikou v Novem Jicine, p.o. p.o. Interni oddeleni - nefrologie a dialyza', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'zip': '7000', 'city': 'Frederica', 'country': 'Denmark', 'facility': 'Lillebalt Frederica Sygehus Department of Nephrology'}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU grenoble - Service de Nephrologie', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '17109', 'city': 'Demmin', 'country': 'Germany', 'facility': 'Praxis Dr. Kraatz', 'geoPoint': {'lat': 53.90762, 'lon': 13.03142}}, {'zip': '47100', 'city': 'Arta', 'country': 'Greece', 'facility': 'General Hospital of Arta - Nephrology Department', 'geoPoint': {'lat': 39.16014, 'lon': 20.98561}}, {'zip': '00042', 'city': 'Anzio', 'country': 'Italy', 'facility': 'Ospedali Riuniti Anzio-Nettuno ASL ROMA H U.O. Nefrologia e Dialisi', 'geoPoint': {'lat': 41.45263, 'lon': 12.62157}}, {'zip': '3816 CP', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medisch Centrum - Locatie Amersfoort Lichtenberg', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': "St. Olav's Hospital", 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '04-749', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Miedzyleski Szpital Spec. Oddzial I Wewnetrzny I Nefrologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital Santa Maria - Nefrologia', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '010731', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic de Nefrologie"Dr Carol Davila"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla - Servicio de Nefrología', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '141', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '01330', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University Medical Faculty Balcali Hospital - Department of Nephrology', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Iain Macdougall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vifor Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}, {'name': 'ICON Clinical Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}