Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-27 @ 10:51 AM
Study NCT ID:
NCT00835068
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2009-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Marketing Observational Study of Reformulated BeneFIX
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002836', 'term': 'Hemophilia B'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.', 'otherNumAtRisk': 57, 'otherNumAffected': 21, 'seriousNumAtRisk': 57, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'BeneFIX (Previously Untreated Participants)', 'description': 'Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Branchial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Mucosal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vitamin D increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthma exercise induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Factor IX inhibition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemophilic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital genitourinary abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}, {'id': 'OG001', 'title': 'BeneFIX (Previously Untreated Participants)', 'description': 'Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'Treatment-related AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Year 3.5', 'description': 'A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of BeneFIX.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}, {'id': 'OG001', 'title': 'BeneFIX (Previously Untreated Participants)', 'description': 'Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 3.5 up to 4.75', 'description': 'AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of BeneFIX. Previously untreated participants were not evaluable for this outcome measure due to discontinuation prior to safety amendment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}, {'id': 'OG001', 'title': 'BeneFIX (Previously Untreated Participants)', 'description': 'Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'FIX inhibitor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Allergic reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RBC agglutination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lack of efficacy/ low recovery', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombotic event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Number of Bleeding Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'Prophylaxis (n=28)', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}]}]}, {'title': 'On demand (n=21)', 'categories': [{'measurements': [{'value': '695', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Year 4.75', 'description': "Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'n' signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category.", 'unitOfMeasure': 'bleeding episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: participants with basal FIX activity less than or equal to (\\<=) 1 percent (%) with real exposure days in diary at least 70% of planned exposure days for prophylaxis period, and without FIX inhibitor before or during study (no FIX inhibitor history at baseline; FIX inhibitor titer \\<0.6 Bethesda Unit \\[BU\\] during follow up).'}, {'type': 'SECONDARY', 'title': 'Number of Bleeding Episodes Requiring Treatment by Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'bleeding episodes', 'counts': [{'value': '955', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'Prophylaxis: 1 Injection (n = 261)', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'On demand: 1 Injection (n = 694)', 'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis: 2 Injection (n = 261)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'On demand: 2 Injection (n = 694)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis: 3 Injection (n = 261)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'On demand: 3 Injection (n = 694)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis: >=4 Injection (n = 261)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'On demand: >=4 Injection (n = 694)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Number of injections (1, 2, 3 or greater than or equal to \\[\\>= 4\\]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme.', 'unitOfMeasure': 'bleeding episodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'bleeding episodes', 'denomUnitsSelected': 'Participants', 'populationDescription': "Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'number of bleeding episodes analyzed' signifies episodes evaluable for this measure. 'n' signifies those bleeding episodes with injection data available during specified period."}, {'type': 'SECONDARY', 'title': 'Total Consumption of BeneFIX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}, {'id': 'OG001', 'title': 'BeneFIX (Previously Untreated Participants)', 'description': 'Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '434751.0', 'spread': '446077.9', 'groupId': 'OG000'}, {'value': '15000.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance.', 'unitOfMeasure': 'International Unit (IU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of BeneFIX. Participants with at least one follow-up visit were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Efficacy by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'Latest assessment: Missing Values', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Very Good', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Good', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Missing Values', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Very Good', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Good', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Missing Values', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Very Good', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Good', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Dose Per Injection of BeneFIX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'Prophylaxis (n=28)', 'categories': [{'measurements': [{'value': '45.3', 'spread': '11.41', 'groupId': 'OG000'}]}]}, {'title': 'On demand (n=21)', 'categories': [{'measurements': [{'value': '49.0', 'spread': '14.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'IU/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'n' signifies participants evaluable for this measure during the specified treatment period."}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Efficacy by Physician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'Latest assessment: Very Good', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Good', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Very Good', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Good', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Moderate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Very Good', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Good', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Ease of Use by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}], 'classes': [{'title': 'Latest assessment: Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Very Good', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Good', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Latest assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Missing Value', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Very Good', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Good', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Worst assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Missing Values', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Very Good', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Good', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Best assessment: Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}, {'id': 'FG001', 'title': 'BeneFIX (Previously Untreated Participants)', 'description': 'Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BeneFIX (Previously Treated Participants)', 'description': 'Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.'}, {'id': 'BG001', 'title': 'BeneFIX (Previously Untreated Participants)', 'description': 'Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.36', 'spread': '16.237', 'groupId': 'BG000'}, {'value': '1.30', 'groupId': 'BG001'}, {'value': '22.98', 'spread': '16.353', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least one dose of BeneFIX.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2009-02-02', 'resultsFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-11', 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment', 'timeFrame': 'Baseline up to Year 3.5', 'description': 'A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment', 'timeFrame': 'Year 3.5 up to 4.75', 'description': 'AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.'}, {'measure': 'Number of Participants With Events of Special Interest', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.'}], 'secondaryOutcomes': [{'measure': 'Number of Bleeding Episodes', 'timeFrame': 'Baseline up to Year 4.75', 'description': "Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'n' signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category."}, {'measure': 'Number of Bleeding Episodes Requiring Treatment by Injection', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Number of injections (1, 2, 3 or greater than or equal to \\[\\>= 4\\]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme.'}, {'measure': 'Total Consumption of BeneFIX', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance.'}, {'measure': 'Subjective Assessment of Efficacy by Participant', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.'}, {'measure': 'Dose Per Injection of BeneFIX', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category.'}, {'measure': 'Subjective Assessment of Efficacy by Physician', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician.'}, {'measure': 'Subjective Assessment of Ease of Use by Participant', 'timeFrame': 'Baseline up to Year 4.75', 'description': 'Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemophilia B', 'observational', 'post marketing study'], 'conditions': ['Hemophilia B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3090X1-4409&StudyName=Post%20Marketing%20Observational%20Study%20of%20reformulated%20BeneFIX', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.', 'detailedDescription': 'No sampling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemophilia B patients already receiving or starting treatment with reformulated BeneFIX', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.\n* Subjects who have dated and signed the informed consent form.\n\nExclusion Criteria:\n\n* Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.\n* Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).'}, 'identificationModule': {'nctId': 'NCT00835068', 'briefTitle': 'Post Marketing Observational Study of Reformulated BeneFIX', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Post Marketing Observational Study Of Reformulated BeneFIX', 'orgStudyIdInfo': {'id': '3090X1-4409'}, 'secondaryIdInfos': [{'id': 'B1821007'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'BeneFIX', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician', 'armGroupLabels': ['BeneFIX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73011', 'city': 'Chamberry', 'state': 'Cedex', 'country': 'France', 'facility': 'Pfizer Investigational Site'}, {'zip': '78157', 'city': 'Le Chesnay', 'state': 'Cedex', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21070', 'city': 'Dijon', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '94275', 'city': 'leKremlin-Bicetre', 'country': 'France', 'facility': 'Pfizer Investigational Site'}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '95160', 'city': 'Montmorency', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.98826, 'lon': 2.3434}}, {'zip': '34 34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'F-75015', 'city': 'Paris', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42277', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}