Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT01758432
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2012-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C580915', 'term': 'PRT064445'}, {'id': 'C522181', 'term': 'apixaban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '650-246-7000', 'title': 'Head of Clinical Development', 'organization': 'Portola Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'Conducted in healthy volunteers at Clinical Research Organization', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '~7 weeks', 'description': 'Only subjects who received at least one dose of study drug were included in the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.', 'otherNumAtRisk': 18, 'otherNumAffected': 14, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min) 420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ocular hyperaemmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vessel puncture site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vessel puncture site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.06', 'spread': '10.801', 'groupId': 'OG000'}, {'value': '-67.79', 'spread': '7.731', 'groupId': 'OG001'}, {'value': '-78.51', 'spread': '3.815', 'groupId': 'OG002'}, {'value': '-95.04', 'spread': '1.375', 'groupId': 'OG003'}, {'value': '-94.03', 'spread': '1.870', 'groupId': 'OG004'}, {'value': '-93.07', 'spread': '1.765', 'groupId': 'OG005'}, {'value': '-92.82', 'spread': '1.267', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-95.74', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-130.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-129.86', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-165.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-167.94', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-135.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 2 minutes following the end of andexanet/placebo administration', 'description': 'Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)', 'unitOfMeasure': 'Percent change in anti-fXa activity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis'}, {'type': 'SECONDARY', 'title': 'Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '28.11', 'spread': '36.871', 'groupId': 'OG000'}, {'value': '76.58', 'spread': '47.729', 'groupId': 'OG001'}, {'value': '137.50', 'spread': '67.528', 'groupId': 'OG002'}, {'value': '120.95', 'spread': '91.301', 'groupId': 'OG003'}, {'value': '222.56', 'spread': '95.671', 'groupId': 'OG004'}, {'value': '196.29', 'spread': '65.406', 'groupId': 'OG005'}, {'value': '191.77', 'spread': '122.385', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85559.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '105508.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '182753.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '193684.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '178055', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '169709.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 2 minutes following the end of andexanet/placebo administration', 'description': 'Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.', 'unitOfMeasure': 'Percent change in thrombin generation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '45 subjects who received andexanet or placebo were included in the PD analysis'}, {'type': 'SECONDARY', 'title': 'Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '-5', 'spread': '14', 'groupId': 'OG000'}, {'value': '-51', 'spread': '12', 'groupId': 'OG001'}, {'value': '-54', 'spread': '7', 'groupId': 'OG002'}, {'value': '-72', 'spread': '7', 'groupId': 'OG003'}, {'value': '-79', 'spread': '6', 'groupId': 'OG004'}, {'value': '-89', 'spread': '3', 'groupId': 'OG005'}, {'value': '-84', 'spread': '6', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.58', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.79', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Least Squares Means (Difference)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.71', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 2 minutes following the end of andexanet/placebo administration', 'description': 'Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay.', 'unitOfMeasure': '% change in unbound apixaban concentrat.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 subjects who received apixaban were included in the apixaban pharmacokinetics (PK) analysis'}, {'type': 'SECONDARY', 'title': 'Andexanet Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Andexanet not administered (placebo group)', 'groupId': 'OG000'}, {'value': '21200', 'spread': '2400', 'groupId': 'OG001'}, {'value': '42800', 'spread': '5620', 'groupId': 'OG002'}, {'value': '81400', 'spread': '10900', 'groupId': 'OG003'}, {'value': '93300', 'spread': '18400', 'groupId': 'OG004'}, {'value': '88000', 'spread': '9010', 'groupId': 'OG005'}, {'value': '90800', 'spread': '29600', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 subjects who received andexanet were included in the andexanet PK analysis'}, {'type': 'SECONDARY', 'title': 'Andexanet Time of Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Andexanet was not administered (placebo group)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.08'}, {'value': '0.15', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.30'}, {'value': '0.27', 'groupId': 'OG003', 'lowerLimit': '0.26', 'upperLimit': '0.29'}, {'value': '0.43', 'groupId': 'OG004', 'lowerLimit': '0.25', 'upperLimit': '0.52'}, {'value': '0.27', 'groupId': 'OG005', 'lowerLimit': '0.26', 'upperLimit': '0.31'}, {'value': '0.28', 'groupId': 'OG006', 'lowerLimit': '0.272', 'upperLimit': '0.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '36 subjects who received andexanet were included in the andexanet PK analysis'}, {'type': 'SECONDARY', 'title': 'Andexanet Total Volume of Distribution (Vss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Andexanet not administered (placebo group)', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '6.18', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '6.26', 'spread': '0.742', 'groupId': 'OG003'}, {'value': '5.11', 'spread': '1.64', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Vss calculations do not take into account the 45 minute intervals between doses.', 'groupId': 'OG005'}, {'value': '4.01', 'spread': '0.951', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 subjects who received andexanet were included in the andexanet PK analysis'}, {'type': 'SECONDARY', 'title': 'Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Andexanet was not administered (placebo group)', 'groupId': 'OG000'}, {'value': '23400', 'spread': '3460', 'groupId': 'OG001'}, {'value': '49200', 'spread': '3960', 'groupId': 'OG002'}, {'value': '93500', 'spread': '15500', 'groupId': 'OG003'}, {'value': '131000', 'spread': '20500', 'groupId': 'OG004'}, {'value': '155000', 'spread': '16200', 'groupId': 'OG005'}, {'value': '213000', 'spread': '33900', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 subjects who received andexanet were included in the andexanet PK analysis'}, {'type': 'SECONDARY', 'title': 'Andexanet Total Systemic Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Andexanet not administered (placebo group)', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '0.634', 'groupId': 'OG001'}, {'value': '4.29', 'spread': '0.331', 'groupId': 'OG002'}, {'value': '4.60', 'spread': '0.814', 'groupId': 'OG003'}, {'value': '4.70', 'spread': '0.887', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not determined as CL', 'groupId': 'OG005'}, {'value': '4.30', 'spread': '0.608', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 subjects who received andexanet were included in the andexanet PK analysis'}, {'type': 'SECONDARY', 'title': 'Andexanet Apparent Terminal Elimination Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'OG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'OG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'OG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'OG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'OG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'OG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Andexanet was not administered (placebo group)', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '5.12', 'spread': '1.66', 'groupId': 'OG002'}, {'value': '5.02', 'spread': '2.02', 'groupId': 'OG003'}, {'value': '4.35', 'spread': '1.40', 'groupId': 'OG004'}, {'value': '5.79', 'spread': '2.00', 'groupId': 'OG005'}, {'value': '6.45', 'spread': '0.41', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electro chemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 subjects who received andexanet were included in the andexanet PK analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'FG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'FG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'FG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'FG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'FG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'FG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject recruitment occurred at investigative site in the US between November 2012 through October 2013', 'preAssignmentDetails': 'Apixaban was administered orally at 5 mg twice daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment (andexanet:placebo, 6:3) intravenously at different doses/dose regimens on Day 6, all bolus doses administered such that they ended at 3 hours after the last dose of apixaban.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Module 1 Placebo', 'description': 'Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.'}, {'id': 'BG001', 'title': 'Module 1 ( 90 mg)', 'description': '90 mg andexanet IV bolus administered over 3 minutes (\\~30 mg/min)'}, {'id': 'BG002', 'title': 'Module 1 (210 mg)', 'description': '210 mg andexanet IV bolus administered over 10 minutes (\\~30 mg/min)'}, {'id': 'BG003', 'title': 'Module 1 (420 mg)', 'description': '420 mg andexanet IV bolus administered over 15 minutes (\\~30 mg/min)'}, {'id': 'BG004', 'title': 'Module 1 (420 mg Bolus + 180 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) \\[total 600 mg\\]'}, {'id': 'BG005', 'title': 'Module 1 (420 mg Bolus + 180 mg Bolus)', 'description': '420 mg andexanet/placebo IV bolus administered over \\~14 minutes (\\~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over\\~ 6 minutes (\\~30 mg/min) \\[total 600 mg\\]'}, {'id': 'BG006', 'title': 'Module 1 (420 mg Bolus + 480 mg Infusion)', 'description': '420 mg andexanet IV bolus administered over \\~14 minutes (\\~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) \\[total 900 mg\\]'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '7.69', 'groupId': 'BG000'}, {'value': '33.7', 'spread': '8.48', 'groupId': 'BG001'}, {'value': '35.0', 'spread': '7.32', 'groupId': 'BG002'}, {'value': '33.8', 'spread': '5.78', 'groupId': 'BG003'}, {'value': '31.7', 'spread': '9.50', 'groupId': 'BG004'}, {'value': '32.5', 'spread': '8.60', 'groupId': 'BG005'}, {'value': '31.8', 'spread': '6.97', 'groupId': 'BG006'}, {'value': '33.2', 'spread': '7.42', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'description': '54 subjects were enrolled in this study.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '46', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '54 subjects were enrolled in this study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.\n\nModule 1, NCT01758432 (54 subjects with 7cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2017-09-19', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2012-12-18', 'dispFirstSubmitQcDate': '2017-09-19', 'resultsFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2012-12-31', 'dispFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-13', 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration', 'timeFrame': 'Baseline to 2 minutes following the end of andexanet/placebo administration', 'description': 'Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration', 'timeFrame': 'Baseline to 2 minutes following the end of andexanet/placebo administration', 'description': 'Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.'}, {'measure': 'Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration', 'timeFrame': 'Baseline to 2 minutes following the end of andexanet/placebo administration', 'description': 'Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay.'}, {'measure': 'Andexanet Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data.'}, {'measure': 'Andexanet Time of Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.'}, {'measure': 'Andexanet Total Volume of Distribution (Vss)', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.'}, {'measure': 'Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach'}, {'measure': 'Andexanet Total Systemic Clearance (CL)', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf'}, {'measure': 'Andexanet Apparent Terminal Elimination Half-life (t1/2)', 'timeFrame': 'Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.', 'description': 'Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electro chemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '29296829', 'type': 'DERIVED', 'citation': 'Siegal D, Lu G, Leeds JM, Karbarz M, Castillo J, Mathur V, Hutchaleelaha A, Sinha U, Kitt M, McClure M, Hollenbach SJ, Curnutte JT, Conley PB, Crowther M. Safety, pharmacokinetics, and reversal of apixaban anticoagulation with andexanet alfa. Blood Adv. 2017 Sep 22;1(21):1827-1838. doi: 10.1182/bloodadvances.2017007112. eCollection 2017 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.', 'detailedDescription': 'A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men or women between the ages of 18 and 45 years old\n\nExclusion Criteria:\n\n* History (including family history) or symptoms of, or risk factors for bleeding\n* History (including family history) of or risk factors for a hypercoagulable or thrombotic condition\n* Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants\n* History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing.'}, 'identificationModule': {'nctId': 'NCT01758432', 'briefTitle': 'Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers', 'orgStudyIdInfo': {'id': '12-502 Module 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Module 1 (90 mg bolus)', 'description': '90 mg PRT064445 given as a single IV', 'interventionNames': ['Combination Product: PRT064445/Apixaban', 'Combination Product: Placebo/Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Module 1 (210 mg bolus)', 'description': '210 mg PRT064445 given as a single IV bolus', 'interventionNames': ['Combination Product: PRT064445/Apixaban', 'Combination Product: Placebo/Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Module 1 (420 mg bolus)', 'description': '420 mg PRT064445 given as a single IV bolus', 'interventionNames': ['Combination Product: PRT064445/Apixaban', 'Combination Product: Placebo/Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Module 1 (420 mg bolus + 180 mg infusion) 4 mg/min', 'description': '600 mg PRT064445 given as follows: 420 mg IV over \\~14 minutes (\\~30 mg/min), followed by a continuous infusion of 180 mg (4 mg/min over 45 minutes)', 'interventionNames': ['Combination Product: PRT064445/Apixaban', 'Combination Product: Placebo/Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Module 1 (420 mg bolus + 180 mg bolus) 30mg/min', 'description': '600 mg PRT064445 given as follows: up to 420 mg IV over \\~14 minutes (\\~30 mg/min), followed by a second bolus of 180 mg IV over \\~6 minutes (\\~30 mg/min), 45 minutes after completion of the bolus', 'interventionNames': ['Combination Product: PRT064445/Apixaban', 'Combination Product: Placebo/Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Module 1 (420 mg bolus + 480 mg infusion) 4mg/min', 'description': '900 mg PRT064445 given as follows: 420 mg IV, followed by a continuous infusion of 480 mg (4 mg/min over 120 minutes', 'interventionNames': ['Combination Product: PRT064445/Apixaban', 'Combination Product: Placebo/Apixaban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Module 1 Placebo', 'description': 'Placebo administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PRT064445/Apixaban', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Andexanet'], 'armGroupLabels': ['Module 1 (210 mg bolus)', 'Module 1 (420 mg bolus + 180 mg bolus) 30mg/min', 'Module 1 (420 mg bolus + 180 mg infusion) 4 mg/min', 'Module 1 (420 mg bolus + 480 mg infusion) 4mg/min', 'Module 1 (420 mg bolus)', 'Module 1 (90 mg bolus)']}, {'name': 'Placebo/Apixaban', 'type': 'COMBINATION_PRODUCT', 'armGroupLabels': ['Module 1 (210 mg bolus)', 'Module 1 (420 mg bolus + 180 mg bolus) 30mg/min', 'Module 1 (420 mg bolus + 180 mg infusion) 4 mg/min', 'Module 1 (420 mg bolus + 480 mg infusion) 4mg/min', 'Module 1 (420 mg bolus)', 'Module 1 (90 mg bolus)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Module 1 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portola Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}