Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-22 @ 12:24 AM
Study NCT ID:
NCT01913405
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2013-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005169', 'term': 'Factor VIII'}, {'id': 'C000609799', 'term': 'BAX 855'}], 'ancestors': [{'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'Agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication. The sponsor requires a review of results communication (e .g. for confidential information) \\>= 30 days prior to submission and may request an additional delay of \\<=180 days (e .g. for intellectual property protection).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the entire study period (2 years and 9 months). For each participant the duration of treatment and therefore the entire study period depended on the nature of each participants invasive procedure (ranged from 43 days to 162 days).', 'description': 'Adverse Events (AEs) were recorded throughout the entire study period from screening to completion/termination. AEs that occurred during or after study treatment are summarized here, AEs that occurred prior to study treatment were listed separately and are not included.', 'eventGroups': [{'id': 'EG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed.", 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 8, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Peritonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}], 'seriousEvents': [{'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 19.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Hemostatic Efficacy Assessment Score (GHEA) - Composed of 3 Individual Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}, {'units': 'Surgeries', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Group', 'description': 'All participants treated with BAX855 with available GHEA score.'}, {'id': 'OG001', 'title': 'Major Orthopedic Surgery', 'description': 'All participants treated with BAX855 for major orthopedic surgery.'}, {'id': 'OG002', 'title': 'Major Non-orthopedic Surgery', 'description': 'All participants treated with BAX855 for major non-orthopedic surgery.'}, {'id': 'OG003', 'title': 'Minor Surgery', 'description': 'All participants treated with BAX855 for minor surgery.'}, {'id': 'OG004', 'title': 'Per Protocol Analysis Group', 'description': 'All participants treated with BAX855 with all 3 hemostatic efficacy assessments available. Only subjects who met all study entry criteria and who had no major protocol violation that impacted hemostatic efficacy assessment were included in this group.'}], 'classes': [{'title': 'Treatment success (GHEA score excellent or good)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '80.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '65.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '36.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '77.9', 'upperLimit': '100.0'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '80.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '65.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '36.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '77.9', 'upperLimit': '100.0'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '11.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '34.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '63.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '22.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hemostatic efficacy assessments were performed intraoperatively, postoperatively on day 1 (approximately 24 hours after surgery) and perioperatively at day 14 or discharge (whichever was first).', 'description': 'GHEA=Sum of 1-3 ratings: Excellent: 7-9 (no category \\<2), Good: 5-7 (no category \\<1), Fair: 3-4 (no category \\<1) 1. Intraoperative and 2. Postoperative (postoperative day 1) hemostatic efficacy assessments: Excellent=3: Blood Loss (BL) ≤ than expected for procedure type in non-hemophilic population (NHP) (≤100%), Good=2: BL ≤50% more than expect. for procedure type in NHP (101-150%), Fair=1: BL \\>50% more than expect. for procedure type in NHP (\\>150%), None=0: Significant bleeding-requiring rescue therapy (RT) 3. Perioperative hemostatic efficacy assessment (day 14 or discharge, whatever is first): Excellent=3: BL and required blood transfusions (BT) less than or similar (≤100%) to that expected for procedure type in NHP, Good=2: BL ≤50% more (101-150%) and BT less than or similar to that expected for procedure type in NHP, Fair=1: BL \\>50% more (\\>150%) and BT greater than expected in NHP, None=0: Significant bleeding-requiring RT, BT substantially greater than expected in NHP', 'unitOfMeasure': 'Percentage of surgeries', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'Full analysis group comprises groups major orthopedic and non-orthopedic and minor surgery. Main analysis was done on the full analysis group (at least one hemostatic assessment available) and supportive analysis was done on the per protocol analysis group (all hemostatic assessments available).'}, {'type': 'SECONDARY', 'title': 'Intraoperative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Group', 'description': 'All participants treated with BAX855 with at least one available hemostatic assessment.'}, {'id': 'OG001', 'title': 'Major Orthopedic Surgery', 'description': 'All participants treated with BAX855 for major orthopedic surgery.'}, {'id': 'OG002', 'title': 'Major Non-orthopedic Surgery', 'description': 'All participants treated with BAX855 for major non-orthopedic surgery.'}, {'id': 'OG003', 'title': 'Minor Surgery', 'description': 'All participants treated with BAX855 for minor surgery.'}], 'classes': [{'title': 'Actual blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '30'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '30'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '50'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Predicted average blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '150'}, {'value': '150', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '150'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '50'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Difference from predicted average blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '135'}, {'value': '125', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '140'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Predicted maximum blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '300'}, {'value': '300', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '300'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '150'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'Difference from predicted maximum blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '280'}, {'value': '275', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '290'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '100'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of surgery until end of surgery.', 'description': 'Actual intraoperative blood loss was assessed at the end of surgery and was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected intraoperative blood loss was predicted preoperatively by the investigator/surgeon.', 'unitOfMeasure': 'Milliliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.'}, {'type': 'SECONDARY', 'title': 'Postoperative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Group', 'description': 'All participants treated with BAX855 with at least one available hemostatic assessment.'}, {'id': 'OG001', 'title': 'Major Orthopedic Surgery', 'description': 'All participants treated with BAX855 for major orthopedic surgery.'}, {'id': 'OG002', 'title': 'Major Non-orthopedic Surgery', 'description': 'All participants treated with BAX855 for major non-orthopedic surgery.'}, {'id': 'OG003', 'title': 'Minor Surgery', 'description': 'All participants treated with BAX855 for minor surgery.'}], 'classes': [{'title': 'Actual blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '825'}, {'value': '750', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '1100'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '33.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Predicted average blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '300'}, {'value': '213.5', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '700'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Difference from predicted average blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'groupId': 'OG000', 'lowerLimit': '-125', 'upperLimit': '4'}, {'value': '-50', 'groupId': 'OG001', 'lowerLimit': '-400', 'upperLimit': '-15'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '-7.5', 'upperLimit': '16.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '196'}]}]}, {'title': 'Predicted maximum blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '600'}, {'value': '450', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '1200'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Difference from predicted maximum blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '148'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '300'}, {'value': '34', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '67.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '196'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From completion of surgery until 24 hours after surgery.', 'description': 'Actual post-operative blood loss assessed at postoperative day 1 was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected postoperative blood loss was predicted pre-operatively by the investigator/surgeon.', 'unitOfMeasure': 'Milliliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.'}, {'type': 'SECONDARY', 'title': 'Overall Perioperative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Group', 'description': 'All participants treated with BAX855 with at least one available hemostatic assessment.'}, {'id': 'OG001', 'title': 'Major Orthopedic Surgery', 'description': 'All participants treated with BAX855 for major orthopedic surgery.'}, {'id': 'OG002', 'title': 'Major Non-orthopedic Surgery', 'description': 'All participants treated with BAX855 for major non-orthopedic surgery.'}, {'id': 'OG003', 'title': 'Minor Surgery', 'description': 'All participants treated with BAX855 for minor surgery.'}], 'classes': [{'title': 'Actual blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '305'}, {'value': '246', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '1210'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '50'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Predicted average blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '800'}, {'value': '675', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '1000'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'Difference from predicted average blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-50', 'upperLimit': '20'}, {'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-210', 'upperLimit': '25'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Predicted maximum blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '1500'}, {'value': '1500', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '1500'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '150'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'Difference from predicted maximum blood loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '250'}, {'value': '122.5', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '400'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '64'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of surgery until discharge or day 14, whichever occurred first.', 'description': 'Actual overall perioperative blood loss (assessed at the end of surgery, at postoperative day 1 and until discharge or day 14 - whichever is first) was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected perioperative blood loss was predicted pre-operatively by the investigator/surgeon.', 'unitOfMeasure': 'Milliliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.'}, {'type': 'SECONDARY', 'title': 'Transfusion Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Group', 'description': 'All participants treated with BAX855 with at least one available hemostatic assessment.'}, {'id': 'OG001', 'title': 'Major Orthopedic Surgery', 'description': 'All participants treated with BAX855 for major orthopedic surgery.'}, {'id': 'OG002', 'title': 'Major Non-orthopedic Surgery', 'description': 'All participants treated with BAX855 for major non-orthopedic surgery.'}, {'id': 'OG003', 'title': 'Minor Surgery', 'description': 'All participants treated with BAX855 for minor surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '438.0', 'spread': '152.86', 'groupId': 'OG000'}, {'value': '384.0', 'spread': '132.49', 'groupId': 'OG001'}, {'value': '600.0', 'spread': 'NA', 'comment': 'only 1 participant analyzed', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From initiation of the surgery to 24 hours after completion of the surgery.', 'description': 'Volume of blood, red blood cells, platelets, and other blood products transfused. Only packed red blood cells were transfused in this study.', 'unitOfMeasure': 'Milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery. Only participants who received blood transfusions are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Bleeding Episodes and Additional Need for Surgical Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Group', 'description': 'All participants treated with BAX855 with at least one available hemostatic assessment.'}, {'id': 'OG001', 'title': 'Major Orthopedic Surgery', 'description': 'All participants treated with BAX855 for major orthopedic surgery.'}, {'id': 'OG002', 'title': 'Major Non-orthopedic Surgery', 'description': 'All participants treated with BAX855 for major non-orthopedic surgery.'}, {'id': 'OG003', 'title': 'Minor Surgery', 'description': 'All participants treated with BAX855 for minor surgery.'}], 'classes': [{'title': 'Bleeding episodes site mucosal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes site joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes site gastrointestinal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes site muscle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes cause spontaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes cause inury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes severity mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes severity moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bleeding episodes severity severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Additional need for surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Intra- and post-operative period, until the last intensified treatment after hospital discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks)', 'description': "Any clinically relevant bleeding episodes (as assessed by the investigator) as well as the need for any further surgical interventions were recorded. If the subject had not resumed his previous treatment after discharge, the occurrence and treatment of bleeding episodes were recorded in the subject's diary.", 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'Only surgeries/participants that have encountered bleeding episodes are reported for the analysis of bleeding episodes (5 surgeries in 5 participants) and all surgeries/participants are reported for the analysis of the need for surgical intervention.'}, {'type': 'SECONDARY', 'title': 'Consumption of BAX855', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Analysis Group', 'description': 'All participants treated with BAX855 with at least one available hemostatic assessment.'}, {'id': 'OG001', 'title': 'Major Orthopedic Surgery', 'description': 'All participants treated with BAX855 for major orthopedic surgery.'}, {'id': 'OG002', 'title': 'Major Non-orthopedic Surgery', 'description': 'All participants treated with BAX855 for major non-orthopedic surgery.'}, {'id': 'OG003', 'title': 'Minor Surgery', 'description': 'All participants treated with BAX855 for minor surgery.'}], 'classes': [{'title': 'Total weight adjusted BAX855 consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '562.076', 'spread': '343.7305', 'groupId': 'OG000'}, {'value': '746.103', 'spread': '320.4581', 'groupId': 'OG001'}, {'value': '507.881', 'spread': '161.8075', 'groupId': 'OG002'}, {'value': '122.673', 'spread': '20.0076', 'groupId': 'OG003'}]}]}, {'title': 'Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.492', 'spread': '15.7678', 'groupId': 'OG000'}, {'value': '69.442', 'spread': '14.4532', 'groupId': 'OG001'}, {'value': '56.852', 'spread': '14.8899', 'groupId': 'OG002'}, {'value': '50.928', 'spread': '12.2700', 'groupId': 'OG003'}]}]}, {'title': 'Postoperative Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.195', 'spread': '13.6755', 'groupId': 'OG000'}, {'value': '37.082', 'spread': '16.0160', 'groupId': 'OG001'}, {'value': '31.141', 'spread': '7.5641', 'groupId': 'OG002'}, {'value': '20.762', 'spread': 'NA', 'comment': 'Standard deviation not calculated as only 1 surgery analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Postoperative Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.409', 'spread': '24.8718', 'groupId': 'OG000'}, {'value': '62.005', 'spread': '25.4147', 'groupId': 'OG001'}, {'value': '50.698', 'spread': '29.2373', 'groupId': 'OG002'}, {'value': '45.388', 'spread': '12.0692', 'groupId': 'OG003'}]}]}, {'title': 'Postoperative Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51.697', 'spread': '27.7558', 'groupId': 'OG000'}, {'value': '52.445', 'spread': '27.4771', 'groupId': 'OG001'}, {'value': '50.076', 'spread': '30.9322', 'groupId': 'OG002'}]}]}, {'title': 'Postoperative Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45.023', 'spread': '24.2793', 'groupId': 'OG000'}, {'value': '47.139', 'spread': '27.1069', 'groupId': 'OG001'}, {'value': '39.943', 'spread': '17.0764', 'groupId': 'OG002'}]}]}, {'title': 'Postoperative Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.593', 'spread': '12.2194', 'groupId': 'OG000'}, {'value': '38.009', 'spread': '13.6782', 'groupId': 'OG001'}, {'value': '32.345', 'spread': '5.3374', 'groupId': 'OG002'}]}]}, {'title': 'Postoperative Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.240', 'spread': '15.1497', 'groupId': 'OG000'}, {'value': '32.333', 'spread': '15.1071', 'groupId': 'OG001'}, {'value': '31.775', 'spread': '21.6822', 'groupId': 'OG002'}]}]}, {'title': 'Postoperative Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.135', 'spread': '13.3132', 'groupId': 'OG000'}, {'value': '35.198', 'spread': '12.8578', 'groupId': 'OG001'}, {'value': '30.415', 'spread': '19.7589', 'groupId': 'OG002'}]}]}, {'title': 'Postoperative Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.955', 'spread': '6.0531', 'groupId': 'OG000'}, {'value': '24.866', 'spread': '5.7495', 'groupId': 'OG001'}, {'value': '17.223', 'spread': 'NA', 'comment': 'Standard deviation not calculated as only 1 surgery analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Postoperative Day 8+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Surgeries', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '136.808', 'spread': '139.3781', 'groupId': 'OG000'}, {'value': '136.808', 'spread': '139.3781', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From initial loading dose until discharge for daily weight-adjusted dose and from first infusion (PK/IR) until end of study for total weight-adjusted dose.', 'description': 'Daily and total weight-adjusted consumption of BAX855 per subject.', 'unitOfMeasure': 'IU/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery. Number of surgeries/participants with BAX855 consumption varies on each postoperative day.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Analysis Group', 'description': 'All participants who underwent a pharmacokinetic assessment with BAX855 infusion.'}], 'classes': [{'title': 'One-stage clotting assay', 'categories': [{'measurements': [{'value': '2743.3', 'spread': '751.83', 'groupId': 'OG000'}]}]}, {'title': 'Chromogenic assay', 'categories': [{'measurements': [{'value': '3201.8', 'spread': '1019.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 was administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period. The area under the plasma concentration/time curve from time 0 to infinity (AUC 0-inf) and the area under the first movement curve from time 0 to infinity (AUMC 0-inf) was calculated as the sum of AUC and AUMC from time 0 to the time of the last quantifiable concentration plus a tail area correction calculated as Ct/λz and Ct/λz(t+1/λz), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and λz is the terminal or disposition rate constant. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.', 'unitOfMeasure': 'IU*h/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours Post-infusion (AUC0-96h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmocokinetic Analysis Group', 'description': 'All participants who underwent a pharmacokinetic assessment with BAX855 infusion.'}], 'classes': [{'title': 'One-stage clotting assay', 'categories': [{'measurements': [{'value': '2701.3', 'spread': '719.52', 'groupId': 'OG000'}]}]}, {'title': 'Chromogenic assay', 'categories': [{'measurements': [{'value': '3153.7', 'spread': '980.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour (h) washout period a single dose of BAX855 will be administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period. The area under the plasma concentration/time curve from time 0 to 96 hours postinfusion (AUC 0-96h) was computed using the linear trapezoidal rule. For the calculation of AUC 0-96h the levels at 96 hours were linearly interpolated/extrapolated from the 2 nearest sampling time points. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.', 'unitOfMeasure': 'IU*h/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Terminal Half-life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Analysis Group', 'description': 'All participants who underwent a pharmacokinetic assessment with BAX855 infusion.'}], 'classes': [{'title': 'One-stage clotting assay', 'categories': [{'measurements': [{'value': '14.63', 'spread': '3.179', 'groupId': 'OG000'}]}]}, {'title': 'Chromogenic assay', 'categories': [{'measurements': [{'value': '14.53', 'spread': '3.137', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Terminal or disposition half-life (HL) was calculated as log e(2)/λz where the terminal or disposition rate constant (λz) was estimated as the slope of a log-linear least squares regression model. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Mean Residence Time (MRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Analysis Group', 'description': 'All participants who underwent a pharmacokinetic assessment with BAX855 infusion.'}], 'classes': [{'title': 'One-stage clotting assay', 'categories': [{'measurements': [{'value': '19.26', 'spread': '4.901', 'groupId': 'OG000'}]}]}, {'title': 'Chromogenic assay', 'categories': [{'measurements': [{'value': '18.68', 'spread': '4.160', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Mean residence time (MRT) was calculated as total area under the moment curve divided by the total area under the curve. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Analysis Group', 'description': 'All participants who underwent a pharmacokinetic assessment with BAX855 infusion.'}], 'classes': [{'title': 'One-stage clotting assay', 'categories': [{'measurements': [{'value': '0.02347', 'spread': '0.006821', 'groupId': 'OG000'}]}]}, {'title': 'Chromogenic assay', 'categories': [{'measurements': [{'value': '0.02042', 'spread': '0.006041', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Systemic clearance (CL) was calculated as the dose in IU/kg divided by the total AUC. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. h = hours', 'unitOfMeasure': 'dL/(kg*h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Apparent Volume of Distribution at Steady State (Vss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Analysis Group', 'description': 'All participants who underwent a pharmacokinetic assessment with BAX855 infusion.'}], 'classes': [{'title': 'One-stage clotting assay', 'categories': [{'measurements': [{'value': '0.4316', 'spread': '0.09633', 'groupId': 'OG000'}]}]}, {'title': 'Chromogenic assay', 'categories': [{'measurements': [{'value': '0.3673', 'spread': '0.09559', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Apparent steady state volume of distribution (Vss) was calculated as dose multiplied with AUMC(0-inf) divided by AUC(0-inf) to square. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.', 'unitOfMeasure': 'dL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Incremental Recovery(IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Analysis Group', 'description': 'All participants who underwent a pharmacokinetic assessment with BAX855 infusion.'}], 'classes': [{'title': 'IR at 15 min post infusion - one-stage clotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.106', 'spread': '0.3823', 'groupId': 'OG000'}]}]}, {'title': 'IR at 15 min post infusion - chromogenic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.721', 'spread': '0.5981', 'groupId': 'OG000'}]}]}, {'title': 'IR at Cmax - one-stage clotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.123', 'spread': '0.4041', 'groupId': 'OG000'}]}]}, {'title': 'IR at Cmax - chromogenic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.677', 'spread': '0.5960', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Incremental recovery (IR) was calculated as C post infusion minus C pre-infusion divided by the dose. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.', 'unitOfMeasure': '(IU/dL):(IU/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'For measurement at 15 min post-infusion only 23 surgeries in 18 participants were available for analysis.'}, {'type': 'SECONDARY', 'title': 'Development of Inhibitory Antibodies to Factor VIII (FVIII)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'Immunogenicity assessment using FVIII inhibitor by Nijmegen method. A 72-hour washout period is required prior to immunogenicity tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.'}, {'type': 'SECONDARY', 'title': 'Development of Treatment Emerging Binding Antibodies to Factor VIII (FVIII), Treatment Emergent Binding Antibodies to PEGylated Recombinant FVIII (BX855), and Treatment Emerging Binding Antibodies to Polyethylene Glycol (PEG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'title': 'Treatment emerging binding antibodies to FVIII IgG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment emerging binding antibodies to FVIII IgM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment emerging binding antibodies to BAX855IgG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment emerging binding antibodies to BAX855IgM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment emerging binding antibodies to PEG IgG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment emerging binding antibodies to PEG IgM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'A 72-hour washout period is required prior to immunogenicity tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.'}, {'type': 'SECONDARY', 'title': 'Development of Treatment Emerging Anti-chinese Hamster Ovary (CHO) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'A 72-hour washout period is required prior to immunogenicity tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Thrombotic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe Allergic Reactions (e.g. Anaphylaxis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.'}, {'type': 'SECONDARY', 'title': 'Other Investigational Product (IP) - Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Vital Signs - Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'title': 'Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.60', 'groupId': 'OG000', 'lowerLimit': '36.30', 'upperLimit': '36.70'}]}]}, {'title': '15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.60', 'groupId': 'OG000', 'lowerLimit': '36.20', 'upperLimit': '36.70'}]}]}, {'title': 'Change at 15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in body temperature were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.', 'unitOfMeasure': '°Celsius', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Vital Signs - Systolic and Diastolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'title': 'Systolic BP: Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '115.0', 'upperLimit': '125.0'}]}]}, {'title': 'Systolic BP: 15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '115.0', 'groupId': 'OG000', 'lowerLimit': '110.0', 'upperLimit': '125.0'}]}]}, {'title': 'Systolic BP: Change at 15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '4.0'}]}]}, {'title': 'Diastolic BP: Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '69.0', 'upperLimit': '80.0'}]}]}, {'title': 'Diastolic BP: 15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '70.0', 'upperLimit': '80.0'}]}]}, {'title': 'Diastolic BP: Change at 15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in systolic and diastolic blood pressure (mmHg) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Vital Signs - Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'title': 'Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '16.0'}]}]}, {'title': '15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '16.0'}]}]}, {'title': 'Change at 15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in Respiratory rate were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.', 'unitOfMeasure': 'breaths/minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Vital Signs - Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'classes': [{'title': 'Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '68.0', 'upperLimit': '74.0'}]}]}, {'title': '15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '77.0'}]}]}, {'title': 'Change at 15 minutes post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Surgeries', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in the pulse rate (beats/minute) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Routine Laboratory Parameters- Hematology and Chemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}, {'units': 'Surgeries', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemoglobin: Abnormal Ncs at Screening - Abnormal cs at EOS', 'description': 'Hematology: The hemoglobin result was abnormal not clinically significant at the screening assessment and changed to abnormal clinically significant at the end of study assessment.'}, {'id': 'OG001', 'title': 'Hematocrit: Abnormal Ncs at Screening - Abnormal cs at EOS', 'description': 'Hematology: The hematocrit result was abnormal not clinically significant at the screening assessment and changed to abnormal clinically significant at the end of study assessment.'}, {'id': 'OG002', 'title': 'Erythrocytes: Normal at Screening - Abnormal cs at EOS', 'description': 'Hematology: The Erythrocytes result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.'}, {'id': 'OG003', 'title': 'Eosinophils/Leucocytes: Normal at Screening Abnormal cs at EOS', 'description': 'Hematology: The Eosinophils/Leucocytes result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.'}, {'id': 'OG004', 'title': 'ALT: Normal at Screening - Abnormal cs at EOS', 'description': 'Chemistry: The ALT result was normal at the screening assessment and changed to abnormal clinically significant at the end of study assessment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Throughout the entire study period from screening to completion/termination (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'Changes in clinical chemistry and hematology parameters from a normal or abnormal not clinically significant (ncs) result at screening to an abnormal and clinically significant (cs) result at the end of study assessment (EOS) are listed. Changes did occur in the following laboratory parameters: Alanine Aminotransferase (ALT) (U/L), Hemoglobin (g/L), Hematocrit, Erythrocytes(TI/L), Eosinophils/Leucocytes.', 'unitOfMeasure': 'Surgeries', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgeries', 'denomUnitsSelected': 'Surgeries', 'populationDescription': 'The outcome measure data include surgical enrollments with results both at screening and at the end of the study for each assay.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Twelve study sites have enrolled participants in seven countries (US, Russia, UK, Bulgaria, Lithuania, Spain, Switzerland). There were 30 surgical enrollments in a total of 23 unique participants. Seven unique participants enrolled more than once, of whom five received study product for more than one surgical procedure.', 'preAssignmentDetails': 'A total of 23 participants provided informed consent and were screened for study participation. Of these, 22 unique participants (29 surgical enrollments) were exposed to study product. One participant discontinued prior to surgery and one subject discontinued after surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and nature of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-100% FVIII trough level, and minor surgery will target an initial 30-60% FVIII trough level. Intra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and nature of the surgery performed."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '13.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2013-06-27', 'resultsFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2013-07-30', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-10', 'studyFirstPostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Hemostatic Efficacy Assessment Score (GHEA) - Composed of 3 Individual Ratings', 'timeFrame': 'Hemostatic efficacy assessments were performed intraoperatively, postoperatively on day 1 (approximately 24 hours after surgery) and perioperatively at day 14 or discharge (whichever was first).', 'description': 'GHEA=Sum of 1-3 ratings: Excellent: 7-9 (no category \\<2), Good: 5-7 (no category \\<1), Fair: 3-4 (no category \\<1) 1. Intraoperative and 2. Postoperative (postoperative day 1) hemostatic efficacy assessments: Excellent=3: Blood Loss (BL) ≤ than expected for procedure type in non-hemophilic population (NHP) (≤100%), Good=2: BL ≤50% more than expect. for procedure type in NHP (101-150%), Fair=1: BL \\>50% more than expect. for procedure type in NHP (\\>150%), None=0: Significant bleeding-requiring rescue therapy (RT) 3. Perioperative hemostatic efficacy assessment (day 14 or discharge, whatever is first): Excellent=3: BL and required blood transfusions (BT) less than or similar (≤100%) to that expected for procedure type in NHP, Good=2: BL ≤50% more (101-150%) and BT less than or similar to that expected for procedure type in NHP, Fair=1: BL \\>50% more (\\>150%) and BT greater than expected in NHP, None=0: Significant bleeding-requiring RT, BT substantially greater than expected in NHP'}], 'secondaryOutcomes': [{'measure': 'Intraoperative Blood Loss', 'timeFrame': 'From initiation of surgery until end of surgery.', 'description': 'Actual intraoperative blood loss was assessed at the end of surgery and was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected intraoperative blood loss was predicted preoperatively by the investigator/surgeon.'}, {'measure': 'Postoperative Blood Loss', 'timeFrame': 'From completion of surgery until 24 hours after surgery.', 'description': 'Actual post-operative blood loss assessed at postoperative day 1 was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected postoperative blood loss was predicted pre-operatively by the investigator/surgeon.'}, {'measure': 'Overall Perioperative Blood Loss', 'timeFrame': 'From start of surgery until discharge or day 14, whichever occurred first.', 'description': 'Actual overall perioperative blood loss (assessed at the end of surgery, at postoperative day 1 and until discharge or day 14 - whichever is first) was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected perioperative blood loss was predicted pre-operatively by the investigator/surgeon.'}, {'measure': 'Transfusion Requirements', 'timeFrame': 'From initiation of the surgery to 24 hours after completion of the surgery.', 'description': 'Volume of blood, red blood cells, platelets, and other blood products transfused. Only packed red blood cells were transfused in this study.'}, {'measure': 'Occurrence of Bleeding Episodes and Additional Need for Surgical Intervention', 'timeFrame': 'Intra- and post-operative period, until the last intensified treatment after hospital discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks)', 'description': "Any clinically relevant bleeding episodes (as assessed by the investigator) as well as the need for any further surgical interventions were recorded. If the subject had not resumed his previous treatment after discharge, the occurrence and treatment of bleeding episodes were recorded in the subject's diary."}, {'measure': 'Consumption of BAX855', 'timeFrame': 'From initial loading dose until discharge for daily weight-adjusted dose and from first infusion (PK/IR) until end of study for total weight-adjusted dose.', 'description': 'Daily and total weight-adjusted consumption of BAX855 per subject.'}, {'measure': 'Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞)', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 was administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period. The area under the plasma concentration/time curve from time 0 to infinity (AUC 0-inf) and the area under the first movement curve from time 0 to infinity (AUMC 0-inf) was calculated as the sum of AUC and AUMC from time 0 to the time of the last quantifiable concentration plus a tail area correction calculated as Ct/λz and Ct/λz(t+1/λz), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and λz is the terminal or disposition rate constant. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.'}, {'measure': 'Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours Post-infusion (AUC0-96h)', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour (h) washout period a single dose of BAX855 will be administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period. The area under the plasma concentration/time curve from time 0 to 96 hours postinfusion (AUC 0-96h) was computed using the linear trapezoidal rule. For the calculation of AUC 0-96h the levels at 96 hours were linearly interpolated/extrapolated from the 2 nearest sampling time points. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.'}, {'measure': 'Pharmacokinetics (PK) - Terminal Half-life (T1/2)', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Terminal or disposition half-life (HL) was calculated as log e(2)/λz where the terminal or disposition rate constant (λz) was estimated as the slope of a log-linear least squares regression model. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.'}, {'measure': 'Pharmacokinetics (PK) - Mean Residence Time (MRT)', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Mean residence time (MRT) was calculated as total area under the moment curve divided by the total area under the curve. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.'}, {'measure': 'Pharmacokinetics (PK) - Clearance (CL)', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Systemic clearance (CL) was calculated as the dose in IU/kg divided by the total AUC. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. h = hours'}, {'measure': 'Pharmacokinetics (PK) - Apparent Volume of Distribution at Steady State (Vss)', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Apparent steady state volume of distribution (Vss) was calculated as dose multiplied with AUMC(0-inf) divided by AUC(0-inf) to square. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.'}, {'measure': 'Pharmacokinetics (PK) - Incremental Recovery(IR)', 'timeFrame': 'PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.', 'description': 'Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period. Incremental recovery (IR) was calculated as C post infusion minus C pre-infusion divided by the dose. Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results.'}, {'measure': 'Development of Inhibitory Antibodies to Factor VIII (FVIII)', 'timeFrame': 'Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'Immunogenicity assessment using FVIII inhibitor by Nijmegen method. A 72-hour washout period is required prior to immunogenicity tests.'}, {'measure': 'Development of Treatment Emerging Binding Antibodies to Factor VIII (FVIII), Treatment Emergent Binding Antibodies to PEGylated Recombinant FVIII (BX855), and Treatment Emerging Binding Antibodies to Polyethylene Glycol (PEG)', 'timeFrame': 'Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'A 72-hour washout period is required prior to immunogenicity tests.'}, {'measure': 'Development of Treatment Emerging Anti-chinese Hamster Ovary (CHO) Antibodies', 'timeFrame': 'Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'A 72-hour washout period is required prior to immunogenicity tests.'}, {'measure': 'Occurrence of Thrombotic Events', 'timeFrame': 'Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).'}, {'measure': 'Incidence of Severe Allergic Reactions (e.g. Anaphylaxis)', 'timeFrame': 'Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).'}, {'measure': 'Other Investigational Product (IP) - Related Adverse Events', 'timeFrame': 'Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).'}, {'measure': 'Clinically Significant Changes in Vital Signs - Body Temperature', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in body temperature were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.'}, {'measure': 'Clinically Significant Changes in Vital Signs - Systolic and Diastolic Blood Pressure (BP)', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in systolic and diastolic blood pressure (mmHg) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.'}, {'measure': 'Clinically Significant Changes in Vital Signs - Respiratory Rate', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in Respiratory rate were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.'}, {'measure': 'Clinically Significant Changes in Vital Signs - Pulse Rate', 'timeFrame': 'Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.', 'description': 'Changes in the pulse rate (beats/minute) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.'}, {'measure': 'Clinically Significant Changes in Routine Laboratory Parameters- Hematology and Chemistry', 'timeFrame': 'Throughout the entire study period from screening to completion/termination (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).', 'description': 'Changes in clinical chemistry and hematology parameters from a normal or abnormal not clinically significant (ncs) result at screening to an abnormal and clinically significant (cs) result at the end of study assessment (EOS) are listed. Changes did occur in the following laboratory parameters: Alanine Aminotransferase (ALT) (U/L), Hemoglobin (g/L), Hematocrit, Erythrocytes(TI/L), Eosinophils/Leucocytes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '27328112', 'type': 'RESULT', 'citation': 'Brand B, Gruppo R, Wynn TT, Griskevicius L, Lopez Fernandez MF, Chapman M, Dvorak T, Pavlova BG, Abbuehl BE. Efficacy and safety of pegylated full-length recombinant factor VIII with extended half-life for perioperative haemostasis in haemophilia A patients. Haemophilia. 2016 Jul;22(4):e251-8. doi: 10.1111/hae.12963. Epub 2016 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant requires an elective major or minor surgical, dental or other invasive procedure (e.g. biopsy, endoscopy).\n* Participant and/or legal representative has/have provided signed informed consent.\n* Participant has severe hemophilia A (Factor VIII (FVIII) level \\<1%) as confirmed by the central lab at screening or a documented FVIII activity level \\<1%.\n* Participant was previously treated with FVIII concentrates with ≥150 documented exposure days (EDs).\n* Participant is currently receiving prophylaxis or on-demand therapy with FVIII concentrate.\n* Participant has a Karnofsky performance score of ≥60 at screening.\n* Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥200 cells/mm\\^3, as confirmed by central laboratory at screening.\n* Participant is Hepatitis C virus negative (HCV-) by antibody or PCR testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis as assessed by the investigator.\n* Participant is willing and able to comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n* Participant has detectable FVIII inhibitory antibodies (≥0.4 Bethesda Unit (BU) using the Nijmegen modification of the Bethesda assay) at screening as determined by the central laboratory or at any timepoint prior to screening (≥0.4 BU using the Nijmegen modification of the Bethesda assay or ≥0.6 BU using the Bethesda assay).\n* History of ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).\n* Participant has a platelet count \\<100 x 10\\^9/L, as confirmed by central laboratory at screening.\n* Participant has severe renal impairment (serum creatinine \\> 2.0 mg/dL), as confirmed by central laboratory at screening.\n* Participant has severe chronic hepatic dysfunction (eg ≥5 X upper limit of normal alanine aminotransferase (ALT), as confirmed by the central laboratory at screening, or a documented International Normalized Ratio (INR) \\> 1.5).\n* Participant has a known hypersensitivity towards mouse or hamster proteins, polysorbate 80 or to PEG.\n* Participant is currently using or has recently (\\< 30 days) used pegylated drugs (other than BAX 855) prior to study participation or is scheduled to use such drugs during trial participation.\n* Participant is currently participating in another clinical drug (other than BAX 855) or device study or use of another investigational product or device within 30 days prior to study entry.\n* Participant has a diagnosis of an inherited or acquired hemostatic defect other than hemophilia A.\n* Participant is currently receiving, or scheduled to receive during the course of the study, an immunomodulating drug (eg, systemic corticosteroid agent at a dose equivalent to hydrocortisone \\>10 mg/day, or alpha interferon) other than anti-retroviral chemotherapy.\n* Participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance.'}, 'identificationModule': {'nctId': 'NCT01913405', 'briefTitle': 'Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures', 'orgStudyIdInfo': {'id': '261204'}, 'secondaryIdInfos': [{'id': '2013-001359-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAX855', 'description': "Pre-operative loading dose: Single loading dose, pre-surgery administered based on each study participant's individual PK results as well as target trough level for type and character of surgery, dental or invasive procedure being performed. In general, major surgery will target an 80-150% FVIII trough level, and minor surgery will target an initial 30-100% FVIII trough level.\n\nIntra-operative and post-operative dosing of BAX855 must be based on pre-dosage measurements of FVIII and the type and character of the surgery performed.", 'interventionNames': ['Biological: PEGylated Recombinant factor VIII (rFVIII)']}], 'interventions': [{'name': 'PEGylated Recombinant factor VIII (rFVIII)', 'type': 'BIOLOGICAL', 'otherNames': ['BAX 855', 'ADYNOVATE'], 'description': 'Lyophilized powder and solvent for solution for injection', 'armGroupLabels': ['BAX855']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Bleeding and Clotting Disorders Institute', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospitals & Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Sciences Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'SHAT of Oncohaematology Diseases', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9003', 'city': 'Varna', 'country': 'Bulgaria', 'facility': "MHAT 'Sv. Marina', EAD", 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santariskiu Clinics, Public Institution', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '610000', 'city': 'Kirov', 'country': 'Russia', 'facility': 'FSHI "Kirov SR Institute of Hematology and Blood Transfusion FMBA"', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitaetsspital Zuerich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '79044', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'SI Institute of Blood Pathology and Transfusion Medicine of AMSU', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3JH', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': "Royal Manchester Children's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}