Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02940860
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C557707', 'term': 'iron isomaltoside 1000'}, {'id': 'C000718030', 'term': 'ferric derisomaltose'}, {'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trial@pharmacosmos.com', 'phone': '+45 5948 5935', 'title': 'Clinical trial disclosure desk', 'organization': 'Pharmacosmos A/S'}, 'certainAgreement': {'otherDetails': 'Institution may publish the study results. Before submission for publication or presentation, Institution shall allow Sponsor not less than 90 days to review any manuscript and not less than 30 days to review any poster presentation, abstract, or any other written or oral material which describes or discloses the study results. If sponsor so requests in writing, Institution shall withhold any publication or presentation for an additional 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time a subjects had signed the informed consent form (CRF) and until they had completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 8 weeks (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 10 weeks (including a 14-day screening period).', 'description': 'An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.', 'eventGroups': [{'id': 'EG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV', 'otherNumAtRisk': 1019, 'deathsNumAtRisk': 1019, 'otherNumAffected': 56, 'seriousNumAtRisk': 1019, 'deathsNumAffected': 3, 'seriousNumAffected': 83}, {'id': 'EG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV', 'otherNumAtRisk': 506, 'deathsNumAtRisk': 506, 'otherNumAffected': 34, 'seriousNumAtRisk': 506, 'deathsNumAffected': 3, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urethral obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gas gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemorrhagic arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1019, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin (Hb) From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '1.31'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.26'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.23', 'estimateComment': 'The Mixed Model for Repeated Measurement (MMRM) used for testing, included the fixed, categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.', 'groupDescription': 'Power:\n\nWith N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.\n\nThe significance level was set to 5%.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 8', 'description': "Efficacy\n\nEvaluate the effect of iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).\n\nResponse was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with NDD-CKD and IDA, when oral iron preparations were ineffective or could not be used, or in whom the Hb measurement at screening in Investigators' opinion were sufficiently low to require rapid repletion of iron stores.", 'unitOfMeasure': 'g/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT). All randomised subjects.'}, {'type': 'PRIMARY', 'title': 'Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '95% two-sided CI (iron isomaltoside)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.86', 'groupDescription': 'Power:\n\nWith N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.\n\nThe significance level was set to 5%.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.77', 'groupDescription': 'Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.48', 'groupDescription': 'Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to week 8', 'description': 'Safety\n\nFor this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.\n\nThe potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).\n\nResults show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set. All randomised subjects who received at least one dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'Composite Cardiovascular Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0248', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 1, 2, and 8', 'description': 'Safety\n\nResults show the composite cardiovascular AEs, that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.\n\nThe reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).\n\nThe potential cardiovascular AEs included the following:\n\n* Death due to any cause\n* Non-fatal myocardial infarction\n* Non-fatal stroke\n* Unstable angina requiring hospitalisation\n* Congestive heart failure requiring hospitalisation or medical intervention\n* Arrhythmias\n* Hypertension\n* Hypotension\n\nResults show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set. All randomised subjects who received at least one dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'Time to First Composite Cardiovascular Safety AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The number of adjudicated and confirmed composite cardiovascular safety AEs was too low (N=42) for estimation of median and 95% CI.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The number of adjudicated and confirmed composite cardiovascular safety AEs was too low (N=35) for estimation of median and 95% CI.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0185', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Safety\n\nTime to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.\n\nTime to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.', 'unitOfMeasure': 'Week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set. All randomised subjects who received at least one dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1011', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Safety\n\nResults show the number of participants who had s-phosphate \\<2 mg/dL at any time from baseline to week 1, 2, 4, or 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set. All randomised subjects who received at least one dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Responder YES week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1002', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Responder YES week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '980', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Responder YES week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '957', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '430', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}, {'title': 'Responder YES week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '967', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '474', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0478', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.87', 'groupDescription': 'Week 1\n\nHb increase of ≥1 g/dL from baseline to week 1.\n\nProportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate.', 'statisticalMethod': 'Repeated measures logistic regressioin', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.36', 'groupDescription': 'Week 2\n\nHb increase of ≥1 g/dL from baseline to week 2.\n\nProportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate.', 'statisticalMethod': 'Repeated measures logistic regressioin', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.79', 'groupDescription': 'Week 4\n\nHb increase of ≥1 g/dL from baseline to week 4.\n\nProportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate.', 'statisticalMethod': 'Repeated measures logistic regressioin', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.27', 'groupDescription': 'Week 8\n\nHb increase of ≥1 g/dL from baseline to week 8.\n\nProportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate.', 'statisticalMethod': 'Repeated measures logistic regressioin', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nResults show Hb responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 1 g/dL from baseline to the week in question was observed (from baseline to week 1, 2, 4, and 8).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Time to Change in Hb Concentration ≥1 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '56'}, {'value': '56', 'comment': 'The 95% Confidence Interval value for this treatment group could not be calculated.', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0174', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nTime to change in Hb concentration ≥1 g/dL.\n\nSubjects who showed Hb concentration increase of ≥1 g/dL (from baseline to week 1, 2, 4, and 8).\n\nFor responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.45', 'groupDescription': 'The proportion of subjects who achieved a Hb level of \\>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 to week 8', 'description': 'Efficacy\n\nHb concentration of \\>12 g/dL at any time from week 1 to week 8.\n\nResults show the number of participants who achieved Hb concentration of \\>12 g/dL at any time from week 1 to week 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.60', 'groupDescription': 'The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.\n\nThe estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 to week 8', 'description': 'Efficacy\n\nResults show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1012', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '873', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '1.38', 'ciUpperLimit': '2.40', 'groupDescription': 'Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.\n\nThe estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 to week 8', 'description': 'Efficacy\n\nProportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Hb Concentration From Baseline to Week 1, 2, and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1001', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '980', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '957', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.31', 'groupDescription': 'Week 1\n\nChange in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.36', 'groupDescription': 'Week 2\n\nChange in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0208', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.28', 'groupDescription': 'Week 4\n\nChange in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, 2, and 4', 'description': 'Efficacy\n\nChange in Hb concentration from baseline to week 1, 2, and 4.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '991', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '492.4', 'spread': '309.7', 'groupId': 'OG000'}, {'value': '183.9', 'spread': '129.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '381.2', 'spread': '283.8', 'groupId': 'OG000'}, {'value': '292.4', 'spread': '210.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '258.4', 'spread': '214.5', 'groupId': 'OG000'}, {'value': '255.4', 'spread': '265.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '191.3', 'spread': '196.1', 'groupId': 'OG000'}, {'value': '187.9', 'spread': '210.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '309.2', 'ciLowerLimit': '280.7', 'ciUpperLimit': '337.8', 'groupDescription': 'Week 1\n\nChange in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95.8', 'ciLowerLimit': '67.9', 'ciUpperLimit': '123.7', 'groupDescription': 'Week 2\n\nChange in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7834', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-21.2', 'ciUpperLimit': '28.1', 'groupDescription': 'Week 4\n\nChange in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7621', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-18.1', 'ciUpperLimit': '24.7', 'groupDescription': 'Week 8\n\nChange in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nChanges in s-ferritin from baseline to weeks 1, 2, 4, and 8.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '989', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.10', 'spread': '31.99', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '23.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '989', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.84', 'spread': '29.79', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '14.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.99', 'spread': '30.00', 'groupId': 'OG000'}, {'value': '5.59', 'spread': '12.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.10', 'spread': '30.17', 'groupId': 'OG000'}, {'value': '5.93', 'spread': '12.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '6.9', 'ciUpperLimit': '10.7', 'groupDescription': 'Week 1\n\nChange in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '2.4', 'groupDescription': 'Week 2\n\nChange in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2403', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.5', 'groupDescription': 'Week 4\n\nChange in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.2', 'groupDescription': 'Week 8\n\nChange in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nChanges in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '940', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.8', 'spread': '99.7', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '71.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'spread': '90.6', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '44.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '917', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '91.2', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '38.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '925', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '91.3', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '41.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.5', 'ciLowerLimit': '20.4', 'ciUpperLimit': '32.7', 'groupDescription': 'Week 1\n\nChange in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '5.1', 'groupDescription': 'Week 2\n\nChange in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '2.6', 'groupDescription': 'Week 4\n\nChange in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '0.8', 'groupDescription': 'Week 8\n\nChange in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.\n\nThe estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nChanges in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8.', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '995', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.04', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '998', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.29', 'spread': '9.84', 'groupId': 'OG000'}, {'value': '7.63', 'spread': '9.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '976', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.13', 'spread': '11.09', 'groupId': 'OG000'}, {'value': '9.07', 'spread': '11.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.92', 'groupDescription': 'Week 1\n\nChange in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.73', 'groupDescription': 'Week 2\n\nChange in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5860', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '1.25', 'groupDescription': 'Week 8\n\nChange in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates.', 'statisticalMethod': 'Mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, 2, and 8', 'description': 'Efficacy\n\nChange in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.\n\nThe Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.\n\nA score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.\n\nTotal score was calculated as shown below:\n\nTotal score= Sum of individual scores x 13 / Number of items answered', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Cost of public transport/taxi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '87'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '46'}]}]}, {'title': 'Cost of parking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '879', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '45'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).', 'unitOfMeasure': 'US dollars ($)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car', 'denoms': [{'units': 'Participants', 'counts': [{'value': '878', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '232'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '240'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).', 'unitOfMeasure': 'miles', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects. The number of participants analyzed were less the number of participants starting the study since not all participants had data collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'Time spent on visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '991', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.3'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.0'}]}]}, {'title': 'Total time spent helping on visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.3'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}], 'classes': [{'title': 'In employment, YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Took time off work to attend, YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Assistance by others to attend visit, YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1013', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '410', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': 'Others took time off work to attend, YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}, {'type': 'SECONDARY', 'title': 'Health Care Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2345', 'groupId': 'OG000'}, {'value': '1166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Health care staff involved in the iron isomaltoside/ferric derisomaltose treatment group.\n\nAssessment of the time used by the health care staff during administration of the investigational product and the administration time (including the observational time).'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Health care staff involved in the iron sucrose treatment group.\n\nAssessment of the time used by the health care staff during administration of the investigational product and the administration time (including the observational time).'}], 'classes': [{'title': 'Time spent per site staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2345', 'groupId': 'OG000'}, {'value': '1166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '20.8'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '20.1'}]}]}, {'title': 'Time spent per subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1020', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.58', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '20.8'}, {'value': '2.33', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '20.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nResources used by the health care staff (per administration), measured by the health care resource use questionnaire.\n\nThe questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. All randomised subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.\n\nSubjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit.'}, {'id': 'FG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose (Venofer®) was the comparator in this trial.\n\nSubjects received iron sucrose (Venofer®), 200 mg IV injection up to a maximum of 5 IV injections within the first 2 weeks, starting at baseline (a cumulative dose of 1000 mg was recommended).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1027'}, {'groupId': 'FG001', 'numSubjects': '511'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '971'}, {'groupId': 'FG001', 'numSubjects': '476'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Non-serious AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Serious AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Moved, poor venous access, transport', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 2560 subjects were screened and 1538 subjects were randomised into the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '1538', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Iron Isomaltoside/Ferric Derisomaltose', 'description': 'Iron isomaltoside/ferric derisomaltose, administered IV'}, {'id': 'BG001', 'title': 'Iron Sucrose', 'description': 'Iron sucrose, administered IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '68.6', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}]}, {'title': '65-84 years', 'categories': [{'measurements': [{'value': '608', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '924', 'groupId': 'BG002'}]}]}, {'title': '> 84 years', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '633', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '962', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '394', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '576', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '476', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '724', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '551', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '814', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '731', 'groupId': 'BG000'}, {'value': '375', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Mexican', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Indigenous Mexican', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mixed (Caucasian and Native american)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Central Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Guyanese', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other (Mixed: not declared)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1027', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '1538', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current smoker', 'classes': [{'title': 'YES', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '909', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '1367', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-14', 'size': 1517627, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-06T06:54', 'hasProtocol': True}, {'date': '2018-04-12', 'size': 1457495, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-06T07:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1538}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'dispFirstSubmitDate': '2019-05-07', 'completionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2016-09-27', 'dispFirstSubmitQcDate': '2019-05-07', 'resultsFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2016-10-19', 'dispFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-24', 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin (Hb) From Baseline to Week 8', 'timeFrame': 'Baseline to week 8', 'description': "Efficacy\n\nEvaluate the effect of iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).\n\nResponse was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with NDD-CKD and IDA, when oral iron preparations were ineffective or could not be used, or in whom the Hb measurement at screening in Investigators' opinion were sufficiently low to require rapid repletion of iron stores."}, {'measure': 'Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions', 'timeFrame': 'Baseline to week 8', 'description': 'Safety\n\nFor this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.\n\nThe potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).\n\nResults show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.'}], 'secondaryOutcomes': [{'measure': 'Composite Cardiovascular Adverse Events (AEs)', 'timeFrame': 'Baseline, week 1, 2, and 8', 'description': 'Safety\n\nResults show the composite cardiovascular AEs, that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.\n\nThe reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).\n\nThe potential cardiovascular AEs included the following:\n\n* Death due to any cause\n* Non-fatal myocardial infarction\n* Non-fatal stroke\n* Unstable angina requiring hospitalisation\n* Congestive heart failure requiring hospitalisation or medical intervention\n* Arrhythmias\n* Hypertension\n* Hypotension\n\nResults show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.'}, {'measure': 'Time to First Composite Cardiovascular Safety AE', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Safety\n\nTime to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.\n\nTime to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.'}, {'measure': 'S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Safety\n\nResults show the number of participants who had s-phosphate \\<2 mg/dL at any time from baseline to week 1, 2, 4, or 8.'}, {'measure': 'Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nResults show Hb responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 1 g/dL from baseline to the week in question was observed (from baseline to week 1, 2, 4, and 8).'}, {'measure': 'Time to Change in Hb Concentration ≥1 g/dL', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nTime to change in Hb concentration ≥1 g/dL.\n\nSubjects who showed Hb concentration increase of ≥1 g/dL (from baseline to week 1, 2, 4, and 8).\n\nFor responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured.'}, {'measure': 'Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8', 'timeFrame': 'Week 1 to week 8', 'description': 'Efficacy\n\nHb concentration of \\>12 g/dL at any time from week 1 to week 8.\n\nResults show the number of participants who achieved Hb concentration of \\>12 g/dL at any time from week 1 to week 8.'}, {'measure': 'Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8', 'timeFrame': 'Week 1 to week 8', 'description': 'Efficacy\n\nResults show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8.'}, {'measure': 'S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8', 'timeFrame': 'Week 1 to week 8', 'description': 'Efficacy\n\nProportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8.'}, {'measure': 'Change in Hb Concentration From Baseline to Week 1, 2, and 4', 'timeFrame': 'Baseline, week 1, 2, and 4', 'description': 'Efficacy\n\nChange in Hb concentration from baseline to week 1, 2, and 4.'}, {'measure': 'Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nChanges in s-ferritin from baseline to weeks 1, 2, 4, and 8.'}, {'measure': 'Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nChanges in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8.'}, {'measure': 'Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8', 'timeFrame': 'Baseline, week 1, 2, 4, and 8', 'description': 'Efficacy\n\nChanges in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8.'}, {'measure': 'Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8', 'timeFrame': 'Baseline, week 1, 2, and 8', 'description': 'Efficacy\n\nChange in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.\n\nThe Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.\n\nA score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.\n\nTotal score was calculated as shown below:\n\nTotal score= Sum of individual scores x 13 / Number of items answered'}, {'measure': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).'}, {'measure': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).'}, {'measure': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).'}, {'measure': 'Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nThe Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).'}, {'measure': 'Health Care Resource Use Questionnaire', 'timeFrame': 'Baseline', 'description': 'Pharmacoeconomics\n\nResources used by the health care staff (per administration), measured by the health care resource use questionnaire.\n\nThe questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.\n\nThe data for this endpoint show the responses at baseline for both treatment groups.\n\nThe frequency of drug administration between the 2 treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Iron Deficiency Anaemia', 'Iron Deficiency Anemia', 'IDA', 'Chronic Kidney Disease', 'CKD', 'Iron isomaltoside', 'Ferric derisomaltose', 'Monofer', 'Monoferric', 'Monover', 'Monofar', 'Monoferro'], 'conditions': ['Iron Deficiency Anaemia', 'Iron Deficiency Anemia', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Sunil Bhandari, Lars Lykke Thomsen. Single 1000 mg infusion of iron isomaltoside1000 single 1000 mg infusion of iron isomaltoside 1000 demonstrates a more rapid hemoglobin response and reduced risk of cardiovascular adverse events compared to multiple dose iron sucrose In patients with iron deficiency anemia and nondialysis-dependent CKD. Nephrology Dialysis Transplantation 34 (Supplement 1): i349-i350, 2019, https://academic.oup.com/ndt/article/34/Supplement_1/gfz101.SaO035/5515662'}, {'pmid': '32049331', 'type': 'DERIVED', 'citation': 'Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):111-120. doi: 10.1093/ndt/gfaa011.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).', 'detailedDescription': 'Iron deficiency anaemia (IDA) is a common problem associated with many chronic diseases such as chronic kidney disease (CKD). IDA can have a substantial medical and quality of life (QoL) burden on the subjects. Therapy of these subjects includes treating the underlying cause of IDA and restoring haemoglobin (Hb) concentration and iron stores.\n\nThis study evaluated the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).\n\nThe study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). The study subjects were monitored for up to 8 weeks from baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria includes:\n\n1. Men and women, ≥ 18 years\n2. Hb ≤ 11 g/dL\n3. Chronic renal impairment, as defined by either (i) eGFR \\< 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) \\< 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model\n4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %\n5. Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation\n6. Willingness to participate and signing the informed consent form\n\nExclusion Criteria includes:\n\n1. Anaemia predominantly caused by factors other than IDA\n2. Hemochromatosis or other iron storage disorders\n3. Previous serious hypersensitivity reactions to any IV iron compounds\n4. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy\n5. Undergoing dialysis for treatment of CKD\n6. Planned surgical procedure within the trial period\n7. Decompensated liver cirrhosis or active hepatitis\n8. Alcohol or drug abuse within the past 6 month.\n9. Pregnant or nursing women.'}, 'identificationModule': {'nctId': 'NCT02940860', 'briefTitle': 'Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmacosmos A/S'}, 'officialTitle': 'A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (FERWON-NEPHRO)', 'orgStudyIdInfo': {'id': 'P-Monofer-CKD-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron isomaltoside/ferric derisomaltose', 'description': 'Administered IV', 'interventionNames': ['Drug: Iron isomaltoside/ferric derisomaltose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iron sucrose', 'description': 'Administered IV', 'interventionNames': ['Drug: Iron sucrose']}], 'interventions': [{'name': 'Iron isomaltoside/ferric derisomaltose', 'type': 'DRUG', 'otherNames': ['Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®'], 'description': 'Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.\n\nThe dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes.', 'armGroupLabels': ['Iron isomaltoside/ferric derisomaltose']}, {'name': 'Iron sucrose', 'type': 'DRUG', 'otherNames': ['Venofer®'], 'description': 'Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial. Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended.', 'armGroupLabels': ['Iron sucrose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '91344', 'city': 'Granada Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 34.26472, 'lon': -118.52314}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacosmos Investigational Site', 'geoPoint': {'lat': 34.05223, 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