Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-02-20 @ 1:34 PM
Study NCT ID:
NCT02137850
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2014-03-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '866-867-7178', 'title': 'Clinical Reporting Office (2834)', 'phoneExt': '(+1)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 28, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 51, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 34}, {'id': 'EG002', 'title': 'Immune Tolerance Induction (ITI)', 'description': 'Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anaesthetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anti factor VIII antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 72, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Factor VIII inhibition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 80, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 75, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tooth loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 35, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vaccine complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anti factor VIII antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arteriovenous fistula operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Device issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Enterobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Factor VIII inhibition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia haemophilus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Post procedural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Spinal epidural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Therapy non-responder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tongue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tooth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urethral repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urogenital fistula repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vaccination site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of the treatment up to 7 years', 'description': 'Number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) was reported during the main and extension phase of the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on safety analysis set (SAS). The SAS consist of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG002', 'title': 'Immune Tolerance Induction (ITI)', 'description': 'Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '644', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Medical events of special interest', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Number of adverse events including serious adverse events and medical events of special interest reported during the main and extension phase of the trial. An adverse event (AE) is any untoward medical occurrence in a patient administered a product, and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is an experience that at any dose results in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect and important medical events that may not result in death, be life threatening or require hospitalisation. Medical event of special interest (MESI) is an event which, in the evaluation of safety, has a special focus.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on SAS. The SAS consists of all participants exposed to N8-GP.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Number of participants with confirmed high titre inhibitors (defined as inhibitor titre above 5 Bethesda Units (BU) was reported during the main and extension phase of the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on safety analysis set (SAS). The SAS consist of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms.'}, {'type': 'SECONDARY', 'title': 'Number of Breakthrough Bleeding Episodes During Prophylaxis With N8-GP (Annualised Bleeding Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '3.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'The number of bleeding episodes per year reported during the prophylactic treatment with N8-GP was reported.', 'unitOfMeasure': 'bleeds/patient/year', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported group. This outcome is applicable only for the reported arms.'}, {'type': 'SECONDARY', 'title': 'Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None")', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'units': 'Bleeds', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG002', 'title': 'Immune Tolerance Induction (ITI)', 'description': 'Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Haemostatic effect of turoctocog alfa pegol for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hours after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms. Number of bleeding episodes in each category is reported.', 'unitOfMeasure': 'Bleeding episodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bleeds', 'denomUnitsSelected': 'Bleeds', 'populationDescription': 'Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Consumption of N8-GP for Prophylaxis (International Unit Per Kilogram (IU/Kg))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '7.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Average dose consumption in IU/kg during main and extension phase is reported.', 'unitOfMeasure': 'IU/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported arm.'}, {'type': 'SECONDARY', 'title': 'Consumption of N8-GP for Prophylaxis (Number of Injections)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '236.6', 'spread': '208.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Number of injections consumption per patient during main and extension phase is reported.', 'unitOfMeasure': 'Injections/patient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported arm.'}, {'type': 'SECONDARY', 'title': 'Consumption of N8-GP for Treatment of Bleeding Episodes (International Unit Per Kilogram Per Bleed (IU/kg/Bleed))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '112.9', 'spread': '113.4', 'groupId': 'OG000'}, {'value': '92.1', 'spread': '71.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for treatment of bleeding episodes (IU/kg/bleed) is reported. Average dose consumption in IU/kg/bleed during main and extension phase is reported.', 'unitOfMeasure': 'IU/kg/bleed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. This outcome is applicable only for the reported arms.'}, {'type': 'SECONDARY', 'title': 'Consumption of N8-GP for Treatment of Bleeding Episodes (Number of Injections)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for treatment of bleeding episodes (number of injections) is reported. Number of average injections required for treatment of per bleed is reported.', 'unitOfMeasure': 'Injections/bleed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP.'}, {'type': 'SECONDARY', 'title': 'Total Consumption of N8-GP Per Patient (Prevention and Treatment of Bleeding Episodes) Annualised Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'OG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2108.6', 'spread': '2697.6', 'groupId': 'OG000'}, {'value': '5394.9', 'spread': '1887.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Total consumption of N8-GP per patient (prevention and treatment of bleeding episodes) annualised value is presented. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Consumption used for treatment per year per patient (IU/kg/year/patient) is reported.', 'unitOfMeasure': 'IU/kg/year/patient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms.'}, {'type': 'SECONDARY', 'title': 'Outcome of ITI, Assessed by a Predefined 4-point ITI Outcome Scale ("Success", "Partial Success", "Failure", "Other")', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerance Induction (ITI)', 'description': 'Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Partial success', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': "The outcome of ITI was evaluated by predefined 4-point outcome of ITI scale ('success', 'partial success', 'failure', 'other'). Success: An inhibitor titre less than (\\<) 0.6 BU. A normalised FVIII recovery, defined as greater than or equal to (≥) 66 percentage (%) of expected incremental recovery. An N8-GP half-life (t½) ≥9 hours after a 72-hour treatment-free washout period. Partial success: Reduction in inhibitor titre to less than or equal to (≤) 5 BU. Clinical effect of N8-GP therapy as judged by the investigator. Failure: Failure to attain defined success or partial success within 24 months of uninterrupted ITI with N8-GP. Inhibitor decrease less than (\\<) 20% after one year of ITI treatment. Other: Not fulfilling the above criteria. Number of participants in each category is reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were based on full analysis set (FAS). This outcome is applicable only for the reported arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-prophylaxis', 'description': 'At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'FG001', 'title': 'Prophylaxis', 'description': 'For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.'}, {'id': 'FG002', 'title': 'Immune Tolerance Induction (ITI)', 'description': 'Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.'}], 'periods': [{'title': 'Main Phase: Pre-Prophylaxis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Main Phase: Prophylaxis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '44 participants were switched from pre-prophylaxis to other two groups during main phase (42 participants were switched to prophylaxis group and 2 participants were switched to immune tolerance induction (ITI) group). Out of 2 participants in immune tolerance induction (ITI) group, 1 participant was again switched from the ITI group to the prophylaxis group and additional 26 participants directly started the Prophylaxis period.', 'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Switched to ITI without completing main phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Early site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Immune Tolerance Induction', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '2 participants were switched from pre-prophylaxis and 6 participants were switched from prophylaxis to immune tolerance induction (ITI) group.', 'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Undergone minor surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Extension Phase: Prophylaxis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Early site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted in 14 countries as follows: Australia (2), Austria (2), Bulgaria (1), Canada (1), Germany (1), Greece (2), Israel (1), Italy (1), Japan (3), Malaysia (3), Spain (2), Taiwan (1), Thailand (3), United States (8).', 'preAssignmentDetails': 'A total of 81 participants were exposed to Turoctocog alfa pegol (N8-GP). Trial consists of main phase: pre-prophylaxis, prophylaxis \\& immune tolerance induction (ITI) and extension phase: prophylaxis period until end of treatment. Pre-prophylaxis was optional and allowed participants to receive treatment until 24 months of age/upon reaching 20EDs, whichever came first. Other participants directly started on prophylaxis treatment at visit 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants received pre-prophylaxis treatment of N8-GP 60 IU/kg intravenous injection as slow start prophylaxis and on-demand treatment of bleeding episodes until they were 24 months of age or until 20 exposure days (ED) on pre-prophylaxis, whichever came first in the main phase. After which they switched to prophylaxis treatment. In prophylaxis, participants received N8-GP 60 IU/kg intravenous injection twice weekly with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. In the extension phase, subjects were to continue the prophylaxis dosing regimen as prescribed at the end of the main phase.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants that started the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-15', 'size': 2082752, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-20T03:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2014-03-28', 'resultsFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2014-05-12', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-10-29', 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII)', 'timeFrame': 'From start of the treatment up to 7 years', 'description': 'Number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) was reported during the main and extension phase of the trial.'}], 'secondaryOutcomes': [{'measure': 'Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Number of adverse events including serious adverse events and medical events of special interest reported during the main and extension phase of the trial. An adverse event (AE) is any untoward medical occurrence in a patient administered a product, and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is an experience that at any dose results in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect and important medical events that may not result in death, be life threatening or require hospitalisation. Medical event of special interest (MESI) is an event which, in the evaluation of safety, has a special focus.'}, {'measure': 'Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU)', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Number of participants with confirmed high titre inhibitors (defined as inhibitor titre above 5 Bethesda Units (BU) was reported during the main and extension phase of the trial.'}, {'measure': 'Number of Breakthrough Bleeding Episodes During Prophylaxis With N8-GP (Annualised Bleeding Rate)', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'The number of bleeding episodes per year reported during the prophylactic treatment with N8-GP was reported.'}, {'measure': 'Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None")', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Haemostatic effect of turoctocog alfa pegol for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hours after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms. Number of bleeding episodes in each category is reported.'}, {'measure': 'Consumption of N8-GP for Prophylaxis (International Unit Per Kilogram (IU/Kg))', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Average dose consumption in IU/kg during main and extension phase is reported.'}, {'measure': 'Consumption of N8-GP for Prophylaxis (Number of Injections)', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Number of injections consumption per patient during main and extension phase is reported.'}, {'measure': 'Consumption of N8-GP for Treatment of Bleeding Episodes (International Unit Per Kilogram Per Bleed (IU/kg/Bleed))', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for treatment of bleeding episodes (IU/kg/bleed) is reported. Average dose consumption in IU/kg/bleed during main and extension phase is reported.'}, {'measure': 'Consumption of N8-GP for Treatment of Bleeding Episodes (Number of Injections)', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Consumption of N8-GP for treatment of bleeding episodes (number of injections) is reported. Number of average injections required for treatment of per bleed is reported.'}, {'measure': 'Total Consumption of N8-GP Per Patient (Prevention and Treatment of Bleeding Episodes) Annualised Value', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': 'Total consumption of N8-GP per patient (prevention and treatment of bleeding episodes) annualised value is presented. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Consumption used for treatment per year per patient (IU/kg/year/patient) is reported.'}, {'measure': 'Outcome of ITI, Assessed by a Predefined 4-point ITI Outcome Scale ("Success", "Partial Success", "Failure", "Other")', 'timeFrame': 'From start of the treatment up to 8.9 years', 'description': "The outcome of ITI was evaluated by predefined 4-point outcome of ITI scale ('success', 'partial success', 'failure', 'other'). Success: An inhibitor titre less than (\\<) 0.6 BU. A normalised FVIII recovery, defined as greater than or equal to (≥) 66 percentage (%) of expected incremental recovery. An N8-GP half-life (t½) ≥9 hours after a 72-hour treatment-free washout period. Partial success: Reduction in inhibitor titre to less than or equal to (≤) 5 BU. Clinical effect of N8-GP therapy as judged by the investigator. Failure: Failure to attain defined success or partial success within 24 months of uninterrupted ITI with N8-GP. Inhibitor decrease less than (\\<) 20% after one year of ITI treatment. Other: Not fulfilling the above criteria. Number of participants in each category is reported."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A']}, 'referencesModule': {'references': [{'pmid': '37597724', 'type': 'DERIVED', 'citation': 'Kenet G, Young G, Chuansumrit A, Matsushita T, Yadav V, Zak M, Male C. The immunogenicity, safety, and efficacy of N8-GP in previously untreated patients with severe hemophilia A: pathfinder6 end-of-trial results. J Thromb Haemost. 2023 Nov;21(11):3109-3116. doi: 10.1016/j.jtha.2023.07.030. Epub 2023 Aug 18.'}, {'pmid': '35858373', 'type': 'DERIVED', 'citation': 'Male C, Konigs C, Dey S, Matsushita T, Millner AH, Zak M, Young G, Kenet G. The safety and efficacy of N8-GP (turoctocog alfa pegol) in previously untreated pediatric patients with hemophilia A. Blood Adv. 2023 Feb 28;7(4):620-629. doi: 10.1182/bloodadvances.2022007529.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Male, age below 6 years of age at the time of signing informed consent\n* Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results\n* No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable)\n\nExclusion Criteria:\n\n* Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products\n* Previous participation in this trial. Participation is defined as first dose administered of trial product\n* Receipt of any investigational medicinal product within 30 days before screening\n* Congenital or acquired coagulation disorder other than haemophilia A\n* Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol\n* Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation"}, 'identificationModule': {'nctId': 'NCT02137850', 'acronym': 'pathfinder™6', 'briefTitle': 'Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A', 'orgStudyIdInfo': {'id': 'NN7088-3908'}, 'secondaryIdInfos': [{'id': '2013-004025-88', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1148-1897', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'REec-2014-0898', 'type': 'REGISTRY', 'domain': 'Spanish Register of Clinical Studies (REec)'}, {'id': 'JapicCTI-142577', 'type': 'OTHER', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 EDs (exposure days)', 'interventionNames': ['Drug: turoctocog alfa pegol']}], 'interventions': [{'name': 'turoctocog alfa pegol', 'type': 'DRUG', 'otherNames': ['NNC 0129-0000-1003', 'N8-GP'], 'description': 'For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis', 'armGroupLabels': ['50 EDs (exposure days)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016-7710', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona H&T Phoenix Child Hosp', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles - Endocrinology", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868-3835', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hosp Of Orange", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90502-2004', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Hospital at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Nemours Chld Clnc Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Nemours Child Orlando Hem/Onc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St Joseph's Hospital Foundation", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University_Atlanta_1', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College Of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St. Luke's Mountain States Tumor Institute", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Med. 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