Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT00708435
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2008-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Armenia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': 'Use email contact', 'title': 'Clinical Trial Disclosure Manager', 'organization': 'CSL Behring'}, 'certainAgreement': {'otherDetails': 'CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.', 'description': 'The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed \'as treated\'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.', 'eventGroups': [{'id': 'EG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight', 'otherNumAtRisk': 103, 'otherNumAffected': 46, 'seriousNumAtRisk': 103, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight', 'otherNumAtRisk': 109, 'otherNumAffected': 40, 'seriousNumAtRisk': 109, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mental status change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung carcinoma cell type unspecified stage iv', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '63.6', 'upperLimit': '81.3'}, {'value': '65.4', 'groupId': 'OG001', 'lowerLimit': '56.2', 'upperLimit': '74.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in effective hemostasis (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '19.9', 'pValueComment': 'Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.', 'estimateComment': 'Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.', 'groupDescription': 'The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.', 'statisticalMethod': '95% confidence interval', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with hemostasis.", 'testedNonInferiority': True, 'nonInferiorityComment': "The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \\>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.\n\nThe sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 and 4 hours after the end of infusion', 'description': 'Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where \'effective\' was a hemostatic efficacy rating of "excellent" or "good," and \'non-effective\' was a hemostatic efficacy rating of "poor/none".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '52.6', 'upperLimit': '71.8'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '15.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in the decrease of INR (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.6', 'ciLowerLimit': '39.4', 'ciUpperLimit': '65.9', 'pValueComment': 'Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.', 'estimateComment': 'Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.', 'groupDescription': 'The analysis of the percentage of participants who had a rapid decrease of the INR was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with a rapid decrease of the INR.', 'statisticalMethod': '95% confidence interval', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with a rapid decrease of the INR.", 'testedNonInferiority': True, 'nonInferiorityComment': "The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \\>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.\n\nThe sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after end of infusion', 'description': 'A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '64.7', 'upperLimit': '82.2'}, {'value': '67.3', 'groupId': 'OG001', 'lowerLimit': '58.3', 'upperLimit': '76.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 and 6 hours after the start of infusion', 'description': 'Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where \'effective\' was a hemostatic efficacy rating of "excellent" or "good," and \'non-effective\' was a hemostatic efficacy rating of "poor/none".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}], 'classes': [{'title': 'Factor II', 'categories': [{'measurements': [{'value': '2.00', 'spread': '0.879', 'groupId': 'OG000'}]}]}, {'title': 'Factor VII', 'categories': [{'measurements': [{'value': '2.15', 'spread': '2.958', 'groupId': 'OG000'}]}]}, {'title': 'Factor IX', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.711', 'groupId': 'OG000'}]}]}, {'title': 'Factor X', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.871', 'groupId': 'OG000'}]}]}, {'title': 'Protein C', 'categories': [{'measurements': [{'value': '2.04', 'spread': '0.958', 'groupId': 'OG000'}]}]}, {'title': 'Protein S', 'categories': [{'measurements': [{'value': '2.17', 'spread': '1.661', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before infusion and up to 3 h after the start of infusion', 'description': 'The incremental IVR \\[(IU/dL)/(IU/kg)\\] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = \\[maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)\\]/{\\[exact dose of component in drug administered (IU)\\]/\\[body weight (kg)\\]}.', 'unitOfMeasure': '(IU/dL)/(IU/kg body weight)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'title': 'Factor II, pre-infusion (n = 98; 103)', 'categories': [{'measurements': [{'value': '20.1', 'spread': '14.56', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '22.39', 'groupId': 'OG001'}]}]}, {'title': 'Factor II, 0.5 h after infusion start (n = 88; 90)', 'categories': [{'measurements': [{'value': '87.5', 'spread': '44.48', 'groupId': 'OG000'}, {'value': '31.9', 'spread': '22.55', 'groupId': 'OG001'}]}]}, {'title': 'Factor II, 24 h after infusion start (n = 92; 99)', 'categories': [{'measurements': [{'value': '77.1', 'spread': '22.06', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '19.55', 'groupId': 'OG001'}]}]}, {'title': 'Factor VII, pre-infusion (n = 98; 103)', 'categories': [{'measurements': [{'value': '25.9', 'spread': '35.01', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '23.45', 'groupId': 'OG001'}]}]}, {'title': 'Factor VII, 0.5h after infusion start (n = 88; 90)', 'categories': [{'measurements': [{'value': '60.5', 'spread': '45.23', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '26.18', 'groupId': 'OG001'}]}]}, {'title': 'Factor VII, 24 h after infusion start (n = 92; 99)', 'categories': [{'measurements': [{'value': '114.8', 'spread': '165.28', 'groupId': 'OG000'}, {'value': '101.3', 'spread': '79.01', 'groupId': 'OG001'}]}]}, {'title': 'Factor IX, pre-infusion (n = 98; 103)', 'categories': [{'measurements': [{'value': '36.1', 'spread': '22.56', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '27.56', 'groupId': 'OG001'}]}]}, {'title': 'Factor IX, 0.5 h after infusion start (n = 88; 90)', 'categories': [{'measurements': [{'value': '76.8', 'spread': '35.47', 'groupId': 'OG000'}, {'value': '47.7', 'spread': '26.78', 'groupId': 'OG001'}]}]}, {'title': 'Factor IX, 24 h after infusion start (n = 92; 99)', 'categories': [{'measurements': [{'value': '88.5', 'spread': '35.65', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '29.95', 'groupId': 'OG001'}]}]}, {'title': 'Factor X, pre-infusion (n = 98; 102)', 'categories': [{'measurements': [{'value': '13.0', 'spread': '11.25', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '18.83', 'groupId': 'OG001'}]}]}, {'title': 'Factor X, 0.5 h after infusion start (n = 88; 90)', 'categories': [{'measurements': [{'value': '99.8', 'spread': '56.07', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '20.40', 'groupId': 'OG001'}]}]}, {'title': 'Factor X, 24 h after infusion start (n = 92; 99)', 'categories': [{'measurements': [{'value': '83.7', 'spread': '27.05', 'groupId': 'OG000'}, {'value': '58.2', 'spread': '21.78', 'groupId': 'OG001'}]}]}, {'title': 'Protein C, pre-infusion (n = 98; 103)', 'categories': [{'measurements': [{'value': '39.3', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '18.84', 'groupId': 'OG001'}]}]}, {'title': 'Protein C, 0.5 h after infusion start (n = 88; 90)', 'categories': [{'measurements': [{'value': '110.3', 'spread': '47.37', 'groupId': 'OG000'}, {'value': '50.9', 'spread': '24.78', 'groupId': 'OG001'}]}]}, {'title': 'Protein C, 24h after infusion start (n = 92; 98)', 'categories': [{'measurements': [{'value': '90.3', 'spread': '27.19', 'groupId': 'OG000'}, {'value': '82.8', 'spread': '24.34', 'groupId': 'OG001'}]}]}, {'title': 'Protein S, pre-infusion (n = 97; 102)', 'categories': [{'measurements': [{'value': '27.8', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': 'Protein S, 0.5 h after infusion start (n = 88; 89)', 'categories': [{'measurements': [{'value': '59.4', 'spread': '28.56', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '20.45', 'groupId': 'OG001'}]}]}, {'title': 'Protein S, 24 h after infusion start (n = 91; 97)', 'categories': [{'measurements': [{'value': '47.8', 'spread': '16.54', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '16.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From preinfusion until 24 h after the start of infusion', 'description': 'Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.', 'unitOfMeasure': 'percentage of normal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With INR Correction at Various Times After the Start of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'title': '0.5 h', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 h', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3 h', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '6 h', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '12 h', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': '24 h', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.', 'description': 'The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With INR Correction at Various Times After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'title': '2.5 h', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '3 h', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5 h', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '8 h', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '14 h', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': '26 h', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.', 'description': 'The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Transfusion of Red Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of infusion until 24 h after the start of infusion', 'description': 'Red blood cells were packed red blood cells (PRBCs).', 'unitOfMeasure': 'Units of PRBCs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Use of Other Blood Products and Hemostatic Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of infusion until 24 h after the start of infusion', 'description': 'Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.', 'unitOfMeasure': 'Units of blood products', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': '45-Day All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until Day 45', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \\> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'."}, {'type': 'SECONDARY', 'title': 'Overall Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'OG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly treatment-related TEAE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.', 'description': 'Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.'}, {'id': 'FG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "These data are 'on-study' results collected up to the subject's Day 45 visit.", 'groupId': 'FG000', 'numSubjects': '82'}, {'comment': "These data are 'on-study' results collected up to the subject's Day 45 visit.", 'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Death / Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Intervention by primary care physician', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refused hospitalization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Beriplex® P/N', 'description': 'Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight'}, {'id': 'BG001', 'title': 'Fresh Frozen Plasma', 'description': 'Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 to < 75 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': '≥ 75 years', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intention-to-treat population comprised all subjects who were (1) eligible for the study and had (2) signed informed consent and were randomized to 1 of the 2 treatment groups regardless of whether the subjects received study product. In the ITT population, subjects were analyzed "as randomized".'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'dispFirstSubmitDate': '2011-07-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-01', 'studyFirstSubmitDate': '2008-07-01', 'dispFirstSubmitQcDate': '2011-07-12', 'resultsFirstSubmitDate': '2013-06-07', 'studyFirstSubmitQcDate': '2008-07-01', 'dispFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-07', 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed', 'timeFrame': 'At 1 and 4 hours after the end of infusion', 'description': 'Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where \'effective\' was a hemostatic efficacy rating of "excellent" or "good," and \'non-effective\' was a hemostatic efficacy rating of "poor/none".'}, {'measure': 'Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)', 'timeFrame': '30 minutes after end of infusion', 'description': 'A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding', 'timeFrame': 'At 3 and 6 hours after the start of infusion', 'description': 'Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where \'effective\' was a hemostatic efficacy rating of "excellent" or "good," and \'non-effective\' was a hemostatic efficacy rating of "poor/none".'}, {'measure': 'Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex', 'timeFrame': 'Before infusion and up to 3 h after the start of infusion', 'description': 'The incremental IVR \\[(IU/dL)/(IU/kg)\\] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = \\[maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)\\]/{\\[exact dose of component in drug administered (IU)\\]/\\[body weight (kg)\\]}.'}, {'measure': 'Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S', 'timeFrame': 'From preinfusion until 24 h after the start of infusion', 'description': 'Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.'}, {'measure': 'Percentage of Participants With INR Correction at Various Times After the Start of Infusion', 'timeFrame': 'From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.', 'description': 'The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.'}, {'measure': 'Percentage of Participants With INR Correction at Various Times After Randomization', 'timeFrame': 'From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.', 'description': 'The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.'}, {'measure': 'Transfusion of Red Blood Cells', 'timeFrame': 'From the start of infusion until 24 h after the start of infusion', 'description': 'Red blood cells were packed red blood cells (PRBCs).'}, {'measure': 'Use of Other Blood Products and Hemostatic Agents', 'timeFrame': 'From the start of infusion until 24 h after the start of infusion', 'description': 'Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.'}, {'measure': '45-Day All-cause Mortality', 'timeFrame': 'Until Day 45'}, {'measure': 'Overall Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.', 'description': 'Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.'}]}, 'conditionsModule': {'keywords': ['Anticoagulant reversal', 'Prothrombin', 'Complex', 'Concentrate', 'Coagulopathy', 'induced by', 'coumarin', 'derivatives', 'Kcentra'], 'conditions': ['Blood Coagulation Disorders', 'Acute Major Bleeding']}, 'referencesModule': {'references': [{'pmid': '23935011', 'type': 'RESULT', 'citation': 'Sarode R, Milling TJ Jr, Refaai MA, Mangione A, Schneider A, Durn BL, Goldstein JN. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013 Sep 10;128(11):1234-43. doi: 10.1161/CIRCULATIONAHA.113.002283. Epub 2013 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects ≥ 18 years\n* Subjects who have received oral vitamin K-antagonist therapy\n* Subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (Hb) level ≥ 2g/dL, bleeding requiring blood product transfusion\n* INR ≥ 2 within 3 hours before start of study treatment\n* Informed consent has been obtained\n\nExclusion Criteria:\n\n* Expected survival of less than 3 days, or expected surgery in less than 1 day\n* Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control the acute bleeding event\n* Use of unfractionated or low molecular weight heparin use from 24 hours prior to enrollment or expected need within 24 hours after start of infusion\n* For patients with ICH: Glasgow coma score (GCS) \\< 7; intracerebral hematoma volume \\> 30cc as assessed by ABC/21; for subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm; for subarachnoid hemorrhage: any evidence of hydrocephalus; infratentorial ICH location; epidural hematomas; intraventricular extension of hemorrhage; modified Rankin score (mRS) of \\>3 prior to ICH\n* History of thrombotic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within 3 months of enrollment\n* Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies\n* Suspected or confirmed sepsis at time of enrollment\n* Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study\n* Large blood vessel rupture (e.g. in advanced cancer patient)\n* Pre-existing progressive fatal disease with a life expectancy of less than 2 months\n* Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia\n* Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study\n* Presence or history of hypersensitivity to components of the study medication\n* Pregnant or breast-feeding women\n* Prior inclusion in this study or any other CSL Behring-sponsored Beriplex study'}, 'identificationModule': {'nctId': 'NCT00708435', 'briefTitle': 'Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Coumarin Derivatives in Subjects With Acute Major Bleeding', 'orgStudyIdInfo': {'id': 'BE1116_3002'}, 'secondaryIdInfos': [{'id': '1462', 'type': 'OTHER', 'domain': 'CSL Behring'}, {'id': '2007-007861-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beriplex® P/N', 'interventionNames': ['Biological: Beriplex® P/N (Kcentra)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fresh frozen plasma', 'interventionNames': ['Biological: Fresh frozen plasma']}], 'interventions': [{'name': 'Beriplex® P/N (Kcentra)', 'type': 'BIOLOGICAL', 'otherNames': ['Kcentra'], 'description': 'Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight', 'armGroupLabels': ['Beriplex® P/N']}, {'name': 'Fresh frozen plasma', 'type': 'BIOLOGICAL', 'description': 'Intravenous Infusion, dosage depending on baseline INR and body weight', 'armGroupLabels': ['Fresh frozen plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35248-3280', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Franciso', 'state': 'California', 'country': 'United States', 'facility': 'Study Site'}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 39.68372, 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