Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-28 @ 11:14 AM
Study NCT ID:
NCT02453334
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Sponsor:
Organization:
Raw JSON
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Falone, MD MPH', 'phoneExt': '61844', 'organization': 'American Regent, Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 96, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 95, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory, Thoracic and Mediastinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hepatobiliary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory, Thoracic and Mediastinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Blood And Lymphatic System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Infections And Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Renal And Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hepatobiliary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.87', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.6', 'ciLowerLimit': '-28.01', 'ciUpperLimit': '-3.10', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 3 to Week 18', 'description': 'The following participants will be considered to have met the primary endpoint:\n\n* Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18.\n* Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit.\n* Participants who have a non-study intervention prior to Week 18.\n* Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.63', 'spread': '1.000', 'groupId': 'OG000'}, {'value': '9.75', 'spread': '1.008', 'groupId': 'OG001'}]}]}, {'title': 'Day 7 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.901', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.741', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '1.077', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.937', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '1.015', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '1.028', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.84', 'spread': '1.264', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '1.254', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '1.174', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '1.512', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.202', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.274', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.394', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '1.313', 'groupId': 'OG001'}]}]}, {'title': 'Week 18/ET Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '1.718', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.475', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 18', 'description': 'Nonstudy Intervention is defined as any of the following:\n\n* Initiation of erythropoietin for any reason\n* Blood transfusion\n* IV iron\n* Prescribed use of oral iron', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '1.19', 'ciUpperLimit': '3.50', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '4.19', 'ciUpperLimit': '28.51', 'groupDescription': 'Percentage difference', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 18', 'description': 'Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Nonstudy Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-12.85', 'ciUpperLimit': '7.45', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5758', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.60', 'groupDescription': 'Placebo group was used as the denominator for odds ratio calculation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to week 18', 'description': 'Intervention is defined as any of the following:\n\n* Initiation of erythropoietin for any reason\n* Blood transfusion\n* IV iron\n* Prescribed use of oral iron', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2772', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '0.76', 'ciUpperLimit': '2.56', 'pValueComment': 'Placebo group was used as the denominator for odds ratio calculation', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-5.01', 'ciUpperLimit': '16.43', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to week 18', 'description': 'Intervention is defined as any of the following:\n\n* Initiation of erythropoietin for any reason\n* Blood transfusion\n* IV iron\n* Prescribed use of oral iron', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'title': 'Q1, 1st quartile', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '43'}]}]}, {'title': 'Q2, 2nd quartile or median', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '45'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '106'}]}]}, {'title': 'Q3, 3rd quartile', 'categories': [{'measurements': [{'value': '106', 'comment': 'Not applicable because insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not applicable because insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value was estimated using logrank test stratified by country'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 18', 'description': 'Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring a Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-7.60', 'ciUpperLimit': '9.08', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8924', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.29', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to week 18', 'description': 'Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.8', 'ciLowerLimit': '-20.41', 'ciUpperLimit': '0.77', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0740', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.06', 'groupDescription': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Placebo group was used as the denominator for odds ratio calculation.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 7', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Day 7 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-23.31', 'ciUpperLimit': '-0.91', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0446', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.99', 'pValueComment': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Placebo group was used as the denominator for odds ratio calculation'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 2', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Week 2 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.8', 'ciLowerLimit': '-30.90', 'ciUpperLimit': '-8.69', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.63', 'pValueComment': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Placebo group was used as the denominator for odds ratio calculation.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 3', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Week 3 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.4', 'ciLowerLimit': '-33.22', 'ciUpperLimit': '-9.51', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.61', 'pValueComment': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country', 'estimateComment': 'Placebo group was used as the denominator for odds ratio calculation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 6', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Week 6 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.0', 'ciLowerLimit': '-27.73', 'ciUpperLimit': '-4.26', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.79', 'pValueComment': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.', 'estimateComment': 'Placebo group was used as the denominator for odds ratio calculation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 9', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Week 9 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-15.37', 'ciUpperLimit': '6.57', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.26', 'ciUpperLimit': '1.89', 'pValueComment': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.', 'estimateComment': 'Placebo group was used as the denominator for odds ratio calculation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Week 12 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.4', 'ciLowerLimit': '-19.25', 'ciUpperLimit': '4.55', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.43', 'pValueComment': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.', 'estimateComment': 'Placebo group was used as the denominator for odds ratio calculation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 15', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Week 15 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-9.33', 'ciUpperLimit': '15.54', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6508', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.48', 'ciUpperLimit': '3.24', 'estimateComment': 'Placebo group was used as the denominator for odds ratio calculation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The odds ratio (95% \\[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 18', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with both a baseline and at least one post baseline value at Week 18 are included.'}, {'type': 'SECONDARY', 'title': 'Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'title': 'Q1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '43'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '15'}]}]}, {'title': 'Q2', 'categories': [{'measurements': [{'value': '127', 'comment': 'Not available because of the insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': 'NA'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 18', 'description': 'Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'title': 'Q1,1st quartile', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '43'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '15'}]}]}, {'title': '2nd quartile or median', 'categories': [{'measurements': [{'value': '127', 'comment': 'Not available because insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': 'NA'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '64'}]}]}, {'title': 'Q3, 3rd quartile', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not available because insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not available because insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '128', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0063', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was estimated using logrank test stratified by pooled sites.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 18', 'description': 'Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Correlation of Change in Hemoglobin With Baseline Hepcidin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'title': 'Hepcidin in 1st Tertile', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.892', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '1.203', 'groupId': 'OG001'}]}]}, {'title': 'hepcidin in 3rd Tertile', 'categories': [{'measurements': [{'value': '1.28', 'spread': '1.552', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '1.394', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 18.', 'description': 'For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '9.47', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '8.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 7 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '6.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '8.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '7.75', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '7.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '9.70', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '8.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '8.35', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '8.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '9.82', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '8.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '9.65', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '9.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '8.78', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '8.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 18', 'description': 'Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who completed the study from the Modified intention to treat (mITT) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'FG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.\n\nInjectafer'}, {'id': 'BG001', 'title': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.\n\nNormal Saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '10.02', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '9.26', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '9.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Black/African-American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'American Indian/Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.9', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '165.9', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '166.4', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Iron intolerance', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG grade', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eastern Cooperative Oncology Group. The ECOG grading is 0=fully active\n\n1. restricted in physical activity\n2. Capable of all self care unable to carry out activities\n3. Confined more than 50% of waking hours\n4. Completely disabled', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer stage', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stage 0 = No cancer only abnormal cells Stage 1= Small in one area Stage 2 and 3 = Cancer is larger and grown into nearby tissues. Stage 4 = Spread to other parts of body', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-02', 'size': 4552429, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-09T11:09', 'hasProtocol': True}, {'date': '2018-01-03', 'size': 2358769, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-09T10:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2015-05-21', 'resultsFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-15', 'studyFirstPostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18', 'timeFrame': 'Week 3 to Week 18', 'description': 'The following participants will be considered to have met the primary endpoint:\n\n* Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18.\n* Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit.\n* Participants who have a non-study intervention prior to Week 18.\n* Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.'}], 'secondaryOutcomes': [{'measure': 'Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention', 'timeFrame': 'Baseline to Week 18', 'description': 'Nonstudy Intervention is defined as any of the following:\n\n* Initiation of erythropoietin for any reason\n* Blood transfusion\n* IV iron\n* Prescribed use of oral iron'}, {'measure': 'Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention', 'timeFrame': 'Baseline to Week 18', 'description': 'Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention.'}, {'measure': 'Percentage of Participants Who Received Nonstudy Intervention', 'timeFrame': 'Baseline to week 18', 'description': 'Intervention is defined as any of the following:\n\n* Initiation of erythropoietin for any reason\n* Blood transfusion\n* IV iron\n* Prescribed use of oral iron'}, {'measure': 'Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention', 'timeFrame': 'Baseline to week 18', 'description': 'Intervention is defined as any of the following:\n\n* Initiation of erythropoietin for any reason\n* Blood transfusion\n* IV iron\n* Prescribed use of oral iron'}, {'measure': 'Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention', 'timeFrame': 'Baseline to Week 18', 'description': 'Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively'}, {'measure': 'Percentage of Participants Requiring a Blood Transfusion', 'timeFrame': 'Baseline to week 18', 'description': 'Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'timeFrame': 'Baseline to Day 7', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'timeFrame': 'Baseline to Week 2', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'timeFrame': 'Baseline to Week 3', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'timeFrame': 'Baseline to Week 6', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'timeFrame': 'Baseline to Week 9', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.', 'timeFrame': 'Baseline to Week 12', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.', 'timeFrame': 'Baseline to Week 15', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit', 'timeFrame': 'Baseline to Week 18', 'description': 'Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.'}, {'measure': 'Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18', 'timeFrame': 'Baseline to Week 18', 'description': 'Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.'}, {'measure': 'Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18', 'timeFrame': 'From Baseline to Week 18', 'description': 'Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.'}, {'measure': 'Correlation of Change in Hemoglobin With Baseline Hepcidin Level', 'timeFrame': 'Baseline to Week 18.', 'description': 'For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively.'}, {'measure': 'Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18', 'timeFrame': 'Baseline to Week 18', 'description': 'Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer and Chemotherapy Related Anemia']}, 'descriptionModule': {'briefSummary': 'Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.', 'detailedDescription': 'This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects (male of female) ≥ 18 years of age able to give informed consent to the study.\n* Subjects with non-myeloid malignancies\n* Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining.\n* Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.\n* Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =\\<35%\n* Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-2.\n* Life expectancy of at least 6 months.\n* Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.\n\nExclusion Criteria:\n\n* Previous participation in a ferric carboxymaltose clinical trial.\n* Known hypersensitivity reaction to any component of ferric carboxymaltose.\n* Subjects with overt bleeding\n* Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents).\n* Subjects on erythropoiesis-stimulating agents.\n* Requiring dialysis for the treatment of chronic kidney disease.\n* Any non-viral infection.\n* Known positive hepatitis with evidence of active disease.\n* Received an investigational drug within 30 days of screening.\n* Alcohol or drug abuse within the past 6 months.\n* Hemochromatosis or other iron storage disorders.\n* Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.\n* Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study)."}, 'identificationModule': {'nctId': 'NCT02453334', 'acronym': 'IRON CLAD', 'briefTitle': 'Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Multi-center, Randomized, Double-blinded, Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose Injection) in Adults', 'orgStudyIdInfo': {'id': '1VIT14039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injectafer', 'description': '2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.', 'interventionNames': ['Drug: Injectafer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'Injectafer', 'type': 'DRUG', 'otherNames': ['ferric carboxymaltose injection'], 'armGroupLabels': ['Injectafer']}, {'name': 'Normal Saline', 'type': 'OTHER', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92879', 'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Care Research Group, Inc.', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Care Research Group, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Care Research Group, Inc.', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'University Cancer Institute', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'AR Development Solutions', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakes Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. 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