Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-21 @ 8:31 AM
Study NCT ID:
NCT00864851
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2009-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000795', 'term': 'Fabry Disease'}], 'ancestors': [{'id': 'D013106', 'term': 'Sphingolipidoses'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627036', 'term': 'agalsidase alfa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '56 Weeks', 'description': 'Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.', 'eventGroups': [{'id': 'EG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.', 'otherNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.', 'otherNumAtRisk': 19, 'otherNumAffected': 17, 'seriousNumAtRisk': 19, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Overall', 'description': 'Total of all reporting groups.', 'otherNumAtRisk': 44, 'otherNumAffected': 41, 'seriousNumAtRisk': 44, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 39, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Catheter site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Catheter site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Implant site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Implant site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Infusion site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 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complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Spastic paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Month 12 in Left Ventricular Mass Indexed to Height (LVMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '-10.3', 'spread': '11.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Left ventricular mass (LVM) was measured through echocardiography.', 'unitOfMeasure': 'g/m^2.7', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Maximal Oxygen Consumption (VO2 Max) at Peak Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '4.76', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '5.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Exercise tolerance as measured by VO2 max at peak exercise using the standard exponential exercise protocol (STEEP).', 'unitOfMeasure': 'mL/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Distance Walked in 6-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.4', 'spread': '87.7', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '70.5', 'groupId': 'OG001'}, {'value': '24.7', 'spread': '45.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Exercise tolerance using the 6MWT was measured as the total distance walked in 6 minutes.', 'unitOfMeasure': 'm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in the Minnesota Living With Heart Failure Questionnaire (MLHF-Q) Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '12.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': "Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'title': 'Improved ≥ 1 NYHA Functional Class', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Maintained NYHA Functional Class', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': "The NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life. NYHA Classification - The Stages of Heart Failure: Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Plasma Globotriaosylceramide (GB3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.046', 'spread': '2.256', 'groupId': 'OG000'}, {'value': '-2.132', 'spread': '4.363', 'groupId': 'OG001'}, {'value': '-2.076', 'spread': '1.248', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'unitOfMeasure': 'nmol/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '9.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Renal function was assessed by an evaluation of change from baseline to Month 12 in eGFR as calculated using the Modification of Diet for Renal Disease (MDRD) equation.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Urinary Albumin/Creatinine (A/Cr) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.9', 'spread': '624.82', 'groupId': 'OG000'}, {'value': '-54.1', 'spread': '322.51', 'groupId': 'OG001'}, {'value': '-54.2', 'spread': '294.86', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'unitOfMeasure': 'mg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.'}, {'type': 'SECONDARY', 'title': 'Safety Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'OG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'OG003', 'title': 'Overall', 'description': 'Total of all reporting groups.'}], 'classes': [{'title': 'No adverse event (AE)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'At least one AE', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'At least one study drug-related AE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'At least one infusion-related AE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'At least one severe or life-threatening AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'At least one serious AE (SAE)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'At least one study drug-related SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Discontinued due to an AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '56 Weeks', 'description': 'Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal. Analyses were performed on the ITT population because it was identical to the safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'FG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'FG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient uncooperative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Replagal 0.2 mg/kg, IV, Every Other Week', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.'}, {'id': 'BG001', 'title': 'Replagal 0.2 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'BG002', 'title': 'Replagal 0.4 mg/kg, IV, Weekly', 'description': 'Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '7.23', 'groupId': 'BG000'}, {'value': '51.8', 'spread': '11.42', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '9.75', 'groupId': 'BG002'}, {'value': '50.8', 'spread': '9.34', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 to <45 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': '>=45 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Left Ventricular Mass Indexed to Height (LVMI)', 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'spread': '22.8', 'groupId': 'BG000'}, {'value': '82.6', 'spread': '28.3', 'groupId': 'BG001'}, {'value': '99.3', 'spread': '46.2', 'groupId': 'BG002'}, {'value': '81.5', 'spread': '28.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/m^2.7', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Maximal Oxygen Consumption (VO2 max) at Peak Exercise', 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '6.20', 'groupId': 'BG000'}, {'value': '22.6', 'spread': '6.89', 'groupId': 'BG001'}, {'value': '24.0', 'spread': '11.69', 'groupId': 'BG002'}, {'value': '21.6', 'spread': '7.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '0.2 mg/kg Every Other Week: n=19 0.2 mg/kg Weekly: n=16 0.4 mg/kg Weekly: n=4 Total: n=39', 'unitOfMeasure': 'mL/min/kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Distance Walked in 6-Minute Walk Test (6MWT)', 'classes': [{'categories': [{'measurements': [{'value': '459.6', 'spread': '103.0', 'groupId': 'BG000'}, {'value': '514.3', 'spread': '87.3', 'groupId': 'BG001'}, {'value': '530.7', 'spread': '90.2', 'groupId': 'BG002'}, {'value': '492.8', 'spread': '97.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '0.2 mg/kg Every Other Week: n=18 0.2 mg/kg Weekly: n=19 0.4 mg/kg Weekly: n=5 Total: n=42', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Minnesota Living with Heart Failure Questionnaire (MLHF-Q) Summary Score', 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'spread': '23.8', 'groupId': 'BG000'}, {'value': '21.1', 'spread': '21.0', 'groupId': 'BG001'}, {'value': '19.6', 'spread': '26.5', 'groupId': 'BG002'}, {'value': '28.1', 'spread': '23.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline New York Heart Association (NYHA) Functional Class', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Class I: Cardiac disease without limitation of physical activity. Ordinary physical activity does not cause undue symptoms. Class II: Cardiac disease with slight limitation of physical activity. Comfortable at rest, but ordinary physical activity causes symptoms. Class III: Cardiac disease with marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms. Class IV: Cardiac disease and unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Note: Symptoms include fatigue, palpitation or dyspnea', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Plasma Globotriaosylceramide (GB3)', 'classes': [{'categories': [{'measurements': [{'value': '6.067', 'spread': '3.388', 'groupId': 'BG000'}, {'value': '5.652', 'spread': '5.212', 'groupId': 'BG001'}, {'value': '5.292', 'spread': '1.865', 'groupId': 'BG002'}, {'value': '5.800', 'spread': '4.104', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'spread': '34.1', 'groupId': 'BG000'}, {'value': '78.1', 'spread': '33.8', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '31.2', 'groupId': 'BG002'}, {'value': '79.2', 'spread': '33.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Urinary Albumin/Creatinine (A/Cr) Ratio', 'classes': [{'categories': [{'measurements': [{'value': '313.4', 'spread': '614.07', 'groupId': 'BG000'}, {'value': '293.4', 'spread': '521.23', 'groupId': 'BG001'}, {'value': '298.2', 'spread': '175.85', 'groupId': 'BG002'}, {'value': '303.0', 'spread': '532.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/g', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2012-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2009-03-18', 'resultsFirstSubmitDate': '2014-01-30', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-19', 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Month 12 in Left Ventricular Mass Indexed to Height (LVMI)', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Left ventricular mass (LVM) was measured through echocardiography.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Month 12 in Maximal Oxygen Consumption (VO2 Max) at Peak Exercise', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Exercise tolerance as measured by VO2 max at peak exercise using the standard exponential exercise protocol (STEEP).'}, {'measure': 'Change From Baseline to Month 12 in Distance Walked in 6-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Exercise tolerance using the 6MWT was measured as the total distance walked in 6 minutes.'}, {'measure': 'Change From Baseline to Month 12 in the Minnesota Living With Heart Failure Questionnaire (MLHF-Q) Summary Score', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': "Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL."}, {'measure': 'Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': "The NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life. NYHA Classification - The Stages of Heart Failure: Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."}, {'measure': 'Change From Baseline to Month 12 in Plasma Globotriaosylceramide (GB3)', 'timeFrame': 'Baseline, Month 12 (Week 53)'}, {'measure': 'Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline, Month 12 (Week 53)', 'description': 'Renal function was assessed by an evaluation of change from baseline to Month 12 in eGFR as calculated using the Modification of Diet for Renal Disease (MDRD) equation.'}, {'measure': 'Change From Baseline to Month 12 in Urinary Albumin/Creatinine (A/Cr) Ratio', 'timeFrame': 'Baseline, Month 12 (Week 53)'}, {'measure': 'Safety Evaluation', 'timeFrame': '56 Weeks', 'description': 'Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fabry Disease']}, 'referencesModule': {'references': [{'pmid': '20730727', 'type': 'RESULT', 'citation': "Malek LA, Chojnowska L, Spiewak M, Klopotowski M, Misko J, Petryka J, Milosz B, Ruzyllo W. Cardiac magnetic resonance imaging in patients with Fabry's disease. Kardiol Pol. 2010 Aug;68(8):929-34."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.', 'detailedDescription': 'Fabry disease is an inherited, metabolic disease caused by mutations in the GALA gene. Patients with Fabry disease accumulate a complex glycosphingolipid named globotriaosylceramide (Gb3) in various tissues and organs. All organs are affected in Fabry disease but the majority of the morbidity and mortality are caused by cardiac, renal and neurological dysfunction. Accumulation of Gb3 in the heart causes hypertrophic cardiomyopathy, valvular abnormalities, arrhythmias and infarctions. Replagal has been shown to reduce Gb3 from key tissues and organs, and stabilize renal function in patients with Fabry disease. Evidence suggests that Replagal reduces left ventricular mass (LVM) and improves midwall fractional shortening (MFS) of the heart. Left ventricular hypertrophy is a major cause of morbidity and mortality in patients with Fabry disease.\n\nThis is a study of the safety and effectiveness of 3 dosing regimens of Replagal in adult patients with left ventricular hypertrophy due to Fabry disease.\n\nThe primary objective of the study is to compare the effects of 2 dosing regimens of Replagal (0.2 mg/kg IV every other week and 0.2 mg/kg IV weekly) on the reduction of left ventricular mass as measured by echocardiography.\n\nThe secondary objectives of this study are to compare the effects of 2 dosing regimens of Replagal (0.2 mg/kg IV every other week and 0.2 mg/kg IV weekly) on each of the following: exercise tolerance; improvement in disease-specific quality of life in heart failure patients; improvement of heart failure symptoms; magnitude of reduction in Gb3; rate of decline in renal function and improvement in the severity of proteinuria/albuminuria; and safety.\n\nAn alternative treatment regimen of 0.4 mg/kg Replagal IV weekly will also be explored but without formal comparison to the 0.2 mg/kg regimens. The investigation of the safety and efficacy of the 0.4 mg/kg IV weekly regimen is a secondary objective of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years-old;\n* Male:Fabry disease confirmed by deficiency of alfa galactosidase A activity OR Female:Fabry disease confirmed by a mutation of the alfa galactosidase A gene;\n* ERT-naïve;\n* LVM/h \\> 50g/m2.7 for males and \\>47 g/m2.7 for females;\n* Negative pregnancy test at enrollment and contraception use required throughout study for female patients;\n* Signed informed consent;\n\nExclusion Criteria:\n\n* Class IV heart failure;\n* Clinically significant hypertension;\n* Hemodynamically significant valvular stenosis or regurgitation;\n* Morbid obesity;\n* Known autosomal dominant sarcoplasmic contractile protein gene mutation;\n* Treatment with any investigational drug or device within the 30 days;\n* Unable to comply with the protocol as determined by the Investigator;\n* Positive for hepatitis B, hepatitis C or HIV'}, 'identificationModule': {'nctId': 'NCT00864851', 'briefTitle': 'Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multi-Center, Open-Label, Randomized Study Evaluating the Safety and Efficacy of Three Dosing Regimens of Replagal Enzyme Replacement Therapy in Adult Patients With Fabry Disease', 'orgStudyIdInfo': {'id': 'TKT028'}, 'secondaryIdInfos': [{'id': '2007-005543-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Replagal 0.2 mg/kg, IV, every other week', 'description': 'Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.', 'interventionNames': ['Biological: Replagal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Replagal 0.2 mg/kg, IV, weekly', 'description': 'Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.', 'interventionNames': ['Biological: Replagal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Replagal 0.4 mg/kg, IV, weekly', 'description': 'Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.', 'interventionNames': ['Biological: Replagal']}], 'interventions': [{'name': 'Replagal', 'type': 'BIOLOGICAL', 'otherNames': ['algasidase alfa'], 'description': 'Intravenous (IV) infusion for 12 months', 'armGroupLabels': ['Replagal 0.2 mg/kg, IV, every other week', 'Replagal 0.2 mg/kg, IV, weekly', 'Replagal 0.4 mg/kg, IV, weekly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'AKDHC Tucson Access Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Unversity School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22152', 'city': 'Springfield', 'state': 'Virginia', 'country': 'United States', 'facility': 'O & O Alpan, LLC', 'geoPoint': {'lat': 38.78928, 'lon': -77.1872}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '128 OO', 'city': 'Prague', 'country': 'Czechia', 'facility': 'The Charles University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': 'FI-20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Central Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Asunción', 'country': 'Paraguay', 'facility': 'Gobemador Irala y Coronel Lopez - Barrio Sojania', 'geoPoint': {'lat': -25.28646, 'lon': -57.647}}, {'zip': '31-066', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '04-628', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Kardiologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'SI 2380', 'city': 'Slovenj Gradec', 'country': 'Slovenia', 'facility': 'General Hospital Slovenj Gradec', 'geoPoint': {'lat': 46.51088, 'lon': 15.08377}}, {'zip': 'M6 8HD', 'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}