Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-13 @ 6:12 AM
Study NCT ID:
NCT02680756
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062088', 'term': 'ferric maltol'}, {'id': 'C115835', 'term': 'ferric trimaltol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmitchell@shieldtx.com', 'phone': '0044 752 565 6885', 'title': 'Jackie Mitchell MA DPhil', 'organization': 'Shield Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed)', 'description': "The figures provided won't equal the total number of participants as several patients may have had the same AE.\n\n250 patients were randomised: 125 pts in the ferric maltol group \\& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \\& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \\& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \\& lost to follow-up; 3 pts were given FM instead of IV.", 'eventGroups': [{'id': 'EG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 75, 'seriousNumAtRisk': 127, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 43, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 29, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Crohns disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Gastrointestinal disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 69, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 29, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Infections and infestations', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 45, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 32, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'General disorders and administration site conditions', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nervous system disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Musculoskeletal and connective tissue disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Skin and subcutaneous tissue disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injury, poisoning and procedural complications', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Investigations', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Metabolism and nutrition disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Psychiatric disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Eye disorders', 'notes': 'TEAEs in \\<2% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Neoplasms benign, malignant and unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.298', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '-0.06', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\\>=12g/dL women,\\>=13g/dL men) at Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '-0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\\>=12g/dL women, \\>=13g/dL men) at Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 're-evaluated PP'}, {'type': 'SECONDARY', 'title': 'Change in Hb Concentration From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'measurements': [{'value': '2.45', 'spread': '1.449', 'groupId': 'OG000'}, {'value': '3.04', 'spread': '1.576', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in hemoglobin concentration from baseline to Week 12.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '1.493', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '1.686', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \\<9.5 g/dL.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI) Not all subjects were tested.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Hb Concentration Within Normal Limits at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with baseline Hb concentration \\<9.5 g/dL that is within normal limits at Week 12 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Non-anaemic', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'Anaemic', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Non-anaemic', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Anaemic', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Month 6', 'description': 'Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (OC) Not all subjects were tested.'}, {'type': 'SECONDARY', 'title': 'Change in Hb Concentration From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '0.974', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '1.133', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'Change in hemoglobin concentration from baseline to Week 4.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '0.993', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '1.092', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \\<9.5 g/dL.', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Hb Concentration Within Normal Limits at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with baseline Hb concentration \\<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (MI)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Physical Component and Mental Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'title': 'Physical component score', 'categories': [{'measurements': [{'value': '3.0', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '7.52', 'groupId': 'OG001'}]}]}, {'title': 'Mental component score', 'categories': [{'measurements': [{'value': '3.3', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '7.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (LOCF)', 'description': 'A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research \\& general population surveys.\n\nThe SF-36 includes one multi-item scale that assesses 8 health components:\n\nPhysical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; \\& General Health Component.\n\nThese 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score \\& the Physical Component Score where higher values mean a better outcome.\n\nBoth scales range from 0 to 100, where higher scores indicate better health status.\n\nThe survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Treatment-emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'description': 'Number of Patients with Treatment-emergent Adverse Events (AEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects were randomised to IV iron but were given ferric maltol in error.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Treatment-emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'OG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'description': 'Number of Patients with Treatment-emergent Serious Adverse Events (SAEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects were randomised to IV iron but were given ferric maltol in error.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'FG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'Received Treatment', 'comment': '3 pts randomised to IV were given FM instead in error. Some pts in each arm were not treated.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Hb ≤7.5 g/dL', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Blood transfusion for any reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'TSAT above 60% or a ferritin above 800 m', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'None of above or not recorded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'A total of 462 subjects were screened; of these, 212 subjects were not randomised (202 screening failures and 10 not assigned). 250 subjects (54% of the screened population) were randomised: 125 subjects to the ferric maltol group and 125 subjects to the IV iron group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Ferric Iron Compound', 'description': '30 mg capsules to be taken orally twice a day\n\nFerric Maltol'}, {'id': 'BG001', 'title': 'Intravenous Iron', 'description': 'Administered as per the local SmPC/PI\n\nFerric Carboxymaltose'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '14.58', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '15.54', 'groupId': 'BG001'}, {'value': '40.2', 'spread': '15.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '81'}, {'value': '40.4', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '77'}, {'value': '40.2', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian/Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native American/Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fertility status (females)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Sterile', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Post-menopausal', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Potentially fertile', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Not available', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure is applicable to the female population only.'}, {'title': 'Screening Hb for randomisation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'title': '<10 g/dL Female or <11 g/dL Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '≥10 g/dL Female or ≥11 g/dL Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Hb', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'title': '<9.5 g/dL', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': '≥9.5 g/dL', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IBD subgroup', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'categories': [{'title': "Crohn's disease", 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Ulcerative colitis', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-30', 'size': 466895, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-25T09:28', 'hasProtocol': True}, {'date': '2020-07-23', 'size': 1502830, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-05T10:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2016-02-09', 'resultsFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2016-02-09', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-11', 'studyFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline Physical Component and Mental Component Score', 'timeFrame': 'Baseline to Week 52 (LOCF)', 'description': 'A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research \\& general population surveys.\n\nThe SF-36 includes one multi-item scale that assesses 8 health components:\n\nPhysical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; \\& General Health Component.\n\nThese 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score \\& the Physical Component Score where higher values mean a better outcome.\n\nBoth scales range from 0 to 100, where higher scores indicate better health status.\n\nThe survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language.'}, {'measure': 'Number of Patients With Treatment-emergent Adverse Events (AEs)', 'timeFrame': 'Baseline to Week 52', 'description': 'Number of Patients with Treatment-emergent Adverse Events (AEs).'}, {'measure': 'Number of Patients With Treatment-emergent Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline to Week 52', 'description': 'Number of Patients with Treatment-emergent Serious Adverse Events (SAEs).'}], 'primaryOutcomes': [{'measure': 'Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\\>=12g/dL women,\\>=13g/dL men) at Week 12'}, {'measure': 'Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\\>=12g/dL women, \\>=13g/dL men) at Week 12'}], 'secondaryOutcomes': [{'measure': 'Change in Hb Concentration From Baseline to Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in hemoglobin concentration from baseline to Week 12.'}, {'measure': 'Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \\<9.5 g/dL.'}, {'measure': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12.'}, {'measure': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.'}, {'measure': 'Number of Subjects With Hb Concentration Within Normal Limits at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)'}, {'measure': 'Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with baseline Hb concentration \\<9.5 g/dL that is within normal limits at Week 12 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)'}, {'measure': 'Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months', 'timeFrame': 'Baseline to Month 6', 'description': 'Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)'}, {'measure': 'Change in Hb Concentration From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Change in hemoglobin concentration from baseline to Week 4.'}, {'measure': 'Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL', 'timeFrame': 'Baseline to Week 4', 'description': 'Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \\<9.5 g/dL.'}, {'measure': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.'}, {'measure': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.'}, {'measure': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.'}, {'measure': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.'}, {'measure': 'Number of Subjects With Hb Concentration Within Normal Limits at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)'}, {'measure': 'Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with baseline Hb concentration \\<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \\>=12g/dL women, \\>=13g/dL men)'}, {'measure': 'Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.'}, {'measure': 'Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Number of subjects with baseline hemoglobin \\<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iron Deficiency', 'Anaemia', "Crohn's Disease", 'Deficiency Diseases', 'Inflammatory Bowel Diseases', 'Intestinal Diseases'], 'conditions': ['Anemia, Iron-Deficiency', 'Inflammatory Bowel Disease', "Crohn's Disease"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).', 'detailedDescription': 'A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease.\n\nApproximately 242 eligible subjects will be randomised (1:1) to receive one of the following treatments for the duration of the study treatment period (52 weeks):\n\n* Oral ferric maltol, 30 mg capsule bid.\n* Intravenous iron (ferric carboxy maltose) as per SPC\n\nIn the FCM arm IV iron treatment will be repeated if the subject is iron deficient at any of the study visits.\n\nSubject participation in the study will consist of 3 periods:\n\n* Screening: Up to 14 days\n* Randomised Treatment: 52 weeks\n* Post-treatment safety follow-up: 14 days after study medication discontinuation\n\nPrimary efficacy and safety of ferric maltol and Intravenous iron (ferric carboxy maltose) will be evaluated after the first 12 weeks.\n\nEnd of study evaluations will occur at Week 52 or premature discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "All of the following criteria must be met to randomize a subject in the study:\n\n1. Subjects must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved informed consent form and must sign and date the informed consent prior to any study mandated procedure\n2. Subjects must be willing and able to comply with study requirements\n3. Age ≥ 18 years\n4. Subjects must have a confirmed diagnosis of IBD (endoscopic and/or biopsy)\n5. Subjects must be considered suitable for intravenous iron treatment by the Investigator\n6. Subjects must have iron deficiency anaemia defined by the following criteria:\n\n 1. Hb 8.0 g/dL and ≤11.0 g/dL for women OR a Hb 8.0 g/dL and ≤12.0 g/dL for men\n 2. AND Ferritin \\<30ng/ml OR Ferritin \\<100 ng/ml WITH Transferrin saturation (TSAT) \\<20%\n7. Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until they have completed the study and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, or a vasectomized partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate.\n\nA subject who meets any of the following criteria is not eligible for participation in the study.\n\n1. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to:\n\n 1. Untreated or untreatable severe malabsorption syndrome\n 2. Immunosuppressant use. Immunosuppressants are permitted so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis.\n\n Variations to dosing are permitted at the discretion of the investigator so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis\n2. Subject who has received prior to screening:\n\n 1. Within 8 weeks intramuscular or intravenous (IV) iron or administration of depot iron preparation\n 2. Within 2 weeks a blood transfusion\n 3. Oral iron supplementation, taken specifically to treat anaemia, within the previous 4 weeks (Over the Counter (OTC) multivitamins containing iron are permitted)\n3. Subjects with active inflammatory bowel disease as defined by a SCCAI score greater than 5 at Screening or a CDAI score greater than 300 in the Screening period (as assessed using the Screening haematocrit (HCT) and CDAI diary card completed by the subject for 7 days prior to planned randomization).\n4. Subjects with known hypersensitivity or allergy to either the active substance or excipients of ferric maltol capsules or ferric carboxymaltose solution for IV administration\n5. Subjects who have had serious adverse reactions to previous doses of ferric carboxymaltose or any other intravenous iron.\n6. Subjects with contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia.\n7. Subjects with vitamin B12 or folic acid deficiency as determined by the central laboratory screening results. Subjects may start vitamin B12 or folate replacement and rescreen after at least 2 weeks.\n8. Subjects who are pregnant or breast feeding.\n9. Concomitant medical conditions with significant active bleeding likely to initiate or prolong anaemia.\n10. Participation in any other interventional clinical study within 30 days prior to screening.\n11. Subject with cardiovascular, liver, renal, haematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject or severely limit the lifespan of the subject (i.e. unlikely to complete the full duration of the study).\n12. Subject with significant neurologic or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results (e.g., Alzheimer's disease, schizophrenia or other psychosis, active or current alcohol or drug abuse)\n13. Subject who is an inmate of a psychiatric ward, prison, or other state institution.\n14. Subject who is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study.\n15. Subjects with severe renal impairment: creatinine clearance \\<30 mL/min. (Applicable to US sites Only)"}, 'identificationModule': {'nctId': 'NCT02680756', 'briefTitle': 'Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shield Therapeutics'}, 'officialTitle': 'A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'ST10-01-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral ferric iron compound', 'description': '30 mg capsules to be taken orally twice a day for 52 weeks', 'interventionNames': ['Drug: Ferric Maltol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous iron', 'description': 'Administered as per the local summary of product characteristics (SPC)', 'interventionNames': ['Drug: Ferric Carboxy Maltose']}], 'interventions': [{'name': 'Ferric Maltol', 'type': 'DRUG', 'otherNames': ['Feraccru', 'Ferric Trimaltol', 'ST10', 'ST10-01'], 'armGroupLabels': ['Oral ferric iron compound']}, {'name': 'Ferric Carboxy Maltose', 'type': 'DRUG', 'armGroupLabels': ['Intravenous iron']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': 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