Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT01114204
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}, {'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005296', 'term': 'Ferrous Compounds'}, {'id': 'D008903', 'term': 'Minerals'}, {'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': 'CTInterest@covispharma.com', 'title': 'Medical Information', 'organization': 'AMAG Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data have been received by Sponsor, the Site, and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.', 'otherNumAtRisk': 406, 'otherNumAffected': 95, 'seriousNumAtRisk': 406, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.', 'otherNumAtRisk': 199, 'otherNumAffected': 69, 'seriousNumAtRisk': 199, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 6}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood urea decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrointestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': "Bartholin's abscess", 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}], 'classes': [{'title': 'Up to Week 3', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 4', 'categories': [{'measurements': [{'value': '327', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 5', 'categories': [{'measurements': [{'value': '341', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2833', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.58', 'ciLowerLimit': '-3.89', 'ciUpperLimit': '9.06', 'estimateComment': 'The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.', 'groupDescription': 'Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only.\n\nBaseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.', 'nonInferiorityComment': 'The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) through Week 5', 'description': 'Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:\n\nHemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.\n\nBaseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase.\n\nStatistical analysis was performed for data up to Week 5 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Mean Change In Hemoglobin From Baseline To Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 5', 'description': 'Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline).\n\nBaseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}], 'classes': [{'title': 'Up to Week 3', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 4', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 5', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) through Week 5', 'description': 'Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:\n\nHemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Mean Change In TSAT From Baseline To Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '16.80', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '14.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 5', 'description': 'Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline).\n\nBaseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.', 'unitOfMeasure': 'percentage of saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '11.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 5', 'description': 'The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.\n\nMean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as:\n\nFACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).\n\nBaseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '24.0'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '30.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day 1) up to Week 5', 'description': 'The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of intravenous (IV) ferumoxytol 510 milligrams (mg) (17 milliliters \\[mL\\]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'FG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'comment': 'Completed is defined as had study drug and Week 5 visit.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}, {'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other-Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other-Medical monitor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other-Participant request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other-Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was open to enrollment for adult participants with iron deficiency anemia (IDA), defined as hemoglobin \\<10.0 grams (g)/deciliter (dL) and transferrin saturation (TSAT) \\<20%, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '605', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.'}, {'id': 'BG001', 'title': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '14.89', 'groupId': 'BG000'}, {'value': '48.9', 'spread': '14.66', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '14.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 605}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2013-04-03', 'completionDateStruct': {'date': '2012-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2010-04-29', 'dispFirstSubmitQcDate': '2013-04-03', 'resultsFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2010-04-30', 'dispFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-10', 'studyFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5', 'timeFrame': 'Baseline (Day 1) through Week 5', 'description': 'Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:\n\nHemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.\n\nBaseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase.\n\nStatistical analysis was performed for data up to Week 5 only.'}], 'secondaryOutcomes': [{'measure': 'Mean Change In Hemoglobin From Baseline To Week 5', 'timeFrame': 'Baseline (Day 1), Week 5', 'description': 'Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline).\n\nBaseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero.'}, {'measure': 'Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5', 'timeFrame': 'Baseline (Day 1) through Week 5', 'description': 'Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:\n\nHemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders.'}, {'measure': 'Mean Change In TSAT From Baseline To Week 5', 'timeFrame': 'Baseline (Day 1), Week 5', 'description': 'Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline).\n\nBaseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.'}, {'measure': 'Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5', 'timeFrame': 'Baseline (Day 1), Week 5', 'description': 'The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.\n\nMean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as:\n\nFACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).\n\nBaseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.'}, {'measure': 'Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline', 'timeFrame': 'From Baseline (Day 1) up to Week 5', 'description': 'The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Iron deficiency anemia', 'Feraheme', 'ferumoxytol', 'iron sucrose', 'Venofer', 'IDA'], 'conditions': ['Iron Deficiency Anemia']}, 'referencesModule': {'references': [{'pmid': '27462400', 'type': 'BACKGROUND', 'citation': 'Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.'}, {'pmid': '24639149', 'type': 'BACKGROUND', 'citation': 'Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria include:\n\n1. Males and females ≥18 years of age\n2. Participants with IDA defined as having:\n\n 1. Hemoglobin \\<10.0 g/deciliter (dL)\n 2. Transferrin saturation (TSAT) \\<20%\n3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used\n4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study\n\nKey Exclusion Criteria include:\n\n1. History of allergy to IV iron\n2. Allergy to two or more classes of drugs\n3. Participants on dialysis or with an estimated glomerular filtration rate \\<30 mL/minute(min)/1.73 square meter (m\\^2)\n4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test\n5. Hemoglobin ≤7.0 g/dL\n6. Serum ferritin \\>600 nanogram/mL'}, 'identificationModule': {'nctId': 'NCT01114204', 'briefTitle': 'A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AMAG Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia', 'orgStudyIdInfo': {'id': 'AMAG-FER-IDA-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferumoxytol', 'description': 'Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters \\[mL\\]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).', 'interventionNames': ['Drug: Ferumoxytol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iron Sucrose', 'description': 'Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.', 'interventionNames': ['Drug: Iron Sucrose']}], 'interventions': [{'name': 'Ferumoxytol', 'type': 'DRUG', 'otherNames': ['Feraheme'], 'description': 'IV Ferumoxytol', 'armGroupLabels': ['Ferumoxytol']}, {'name': 'Iron Sucrose', 'type': 'DRUG', 'otherNames': ['Venofer'], 'description': 'IV Iron Sucrose', 'armGroupLabels': ['Iron Sucrose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Ballarat', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -37.56622, 'lon': 143.84957}}, {'city': 'Concord', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'city': 'Five Dock', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.8674, 'lon': 151.12905}}, {'city': 'Gosford', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'city': 'Kingswood', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.75614, 'lon': 150.72346}}, {'city': 'Parkville', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'La Tronche', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60322', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '60431', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': 'D-55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Siegen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'city': 'Wilhelmshaven', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.5476, 'lon': 8.10395}}, {'city': 'Békéscsaba', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'city': 'Gyula', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'city': 'Komárom', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.74318, 'lon': 18.11913}}, {'city': 'Miskolc', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'city': 'Szolnok', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'city': 'Vác', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.77591, 'lon': 19.13612}}, {'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Rozzano', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'zip': 'LV-1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1005', 'city': 'Riga', 'country': 'Latvia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1006', 'city': 'Riga', 'country': 'Latvia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1010', 'city': 'Riga', 'country': 'Latvia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1013', 'city': 'Riga', 'country': 'Latvia', 'facility': 'For additional this triinformation regarding investigative sites for al, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-3601', 'city': 'Ventspils', 'country': 'Latvia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 57.39485, 'lon': 21.56121}}, {'city': 'Ventspils', 'country': 'Latvia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 57.39485, 'lon': 21.56121}}, {'zip': 'LT-48259', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-49449', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-50185', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'city': 'Šiauliai', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.93333, 'lon': 23.31667}}, {'zip': 'LT-03215', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': 'LT-08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Sopot', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'zip': '02-341', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '03-580', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Zgierz', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.85561, 'lon': 19.40623}}, {'city': 'Łęczyca', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.05959, 'lon': 19.19972}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '011422', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '020125', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Suceava', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.63333, 'lon': 26.25}}, {'zip': '540136', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '540461', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '300158', 'city': 'Timișoara', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '300593', 'city': 'Timișoara', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '7500', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7530', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '4001', 'city': 'Durban', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4091', 'city': 'Durban', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Roodepoort', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -26.1625, 'lon': 27.8725}}, {'city': 'Stellenbosch', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.93462, 'lon': 18.86676}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110-774', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '442-723', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '443-721', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Manresa', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Cherkasy', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'city': 'Chernivtsi', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.29045, 'lon': 25.93241}}, {'zip': '83045', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '83114', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '01030', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '01034', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04050', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04112', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Odesa', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Simferopol', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.95719, 'lon': 34.11079}}, {'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AMAG Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}