Viewing Study NCT01527357

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Ignite Creation Date: 2025-12-24 @ 7:08 PM
Ignite Modification Date: 2026-01-05 @ 2:37 AM
Study NCT ID: NCT01527357
Status: COMPLETED
Last Update Posted: 2019-12-18
First Post: 2012-01-26
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Fibrocaps™ in Surgical Bleeding
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}, {'id': 'D005781', 'term': 'Gelatin Sponge, Absorbable'}, {'id': 'D005339', 'term': 'Fibrin Foam'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015503', 'term': 'Surgical Sponges'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@mnk.com', 'phone': '800-556-3314', 'title': 'Medical Information Call Center', 'organization': 'Mallinckrodt Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From time of surgery (Day 1) through Day 29 (End of Study)', 'description': 'Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.', 'eventGroups': [{'id': 'EG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.', 'otherNumAtRisk': 480, 'deathsNumAtRisk': 480, 'otherNumAffected': 426, 'seriousNumAtRisk': 480, 'deathsNumAffected': 8, 'seriousNumAffected': 81}, {'id': 'EG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.', 'otherNumAtRisk': 239, 'deathsNumAtRisk': 239, 'otherNumAffected': 214, 'seriousNumAtRisk': 239, 'deathsNumAffected': 2, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 257}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 134}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 32}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Infectious peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Subdiaphragmatic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Post procedural bile leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Small-for-size liver syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vascular graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anaesthetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anastomotic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastrointestinal disorder postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pancreatic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Postoperative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pseudomeningocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastroduodenal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Localised intraabdominal fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Small intestinal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lymphorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Silent myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Unintentional medical device removal by patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gallbladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatitis C antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population consists of all participants who were randomized, received study treatment, and had a TTH assessment. Number analyzed is the number of participants in the efficacy population who receive each type of surgery.'}, {'type': 'PRIMARY', 'title': 'Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '2.50'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '5.00'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'PRIMARY', 'title': 'Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '2.50'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'PRIMARY', 'title': 'Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '3.50'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'SECONDARY', 'title': 'Restricted Mean TTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'title': 'Spinal Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Hepatic Resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Soft Tissue Dissection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 5 minutes', 'description': "Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population. Number analyzed is the number of participants with data available for analysis in each surgery type.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '426', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 29 days', 'description': 'An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, defined as all participants who were randomized and received study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes', 'description': 'If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Required Red Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'OG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 29 days', 'description': 'Red blood cells are defined as including World Health Organization (WHO) DRUG terms of "Blood cells, packed human", "Blood, whole", "Red blood cells", "Red blood cells, concentrated" and "Red blood cells, leucocyte depleted".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'FG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '482'}, {'groupId': 'FG001', 'numSubjects': '239'}]}, {'type': 'Efficacy Population', 'achievements': [{'comment': 'Two participants did not receive study treatment.', 'groupId': 'FG000', 'numSubjects': '480'}, {'groupId': 'FG001', 'numSubjects': '239'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '465'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No Day 29 Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did Not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled from May 2012 to April 2013 at 57 investigative sites (United States, n = 28; United Kingdom, n = 12; The Netherlands, n = 11; and Belgium, n = 6), and were randomized 2:1 to receive treatment with Fibrocaps plus gelatin sponge or gelatin sponge alone.', 'preAssignmentDetails': 'After screening, 719 eligible participants had surgery in 1 of 4 surgical indications (i.e., spinal, hepatic, vascular, or soft tissue dissection) on Day 1 according to local standard practice, and received treatment with the investigational product assigned.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.'}, {'id': 'BG001', 'title': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '14.44', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '14.12', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '14.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '422', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '632', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 721}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2014-04-14', 'completionDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2012-01-26', 'dispFirstSubmitQcDate': '2014-05-07', 'resultsFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2012-02-06', 'dispFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-05', 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.'}, {'measure': 'Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.'}, {'measure': 'Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.'}, {'measure': 'Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection', 'timeFrame': 'Within 5 minutes', 'description': 'The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.'}], 'secondaryOutcomes': [{'measure': 'Restricted Mean TTH', 'timeFrame': 'Within 5 minutes', 'description': "Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment."}, {'measure': 'Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Within 29 days', 'description': 'An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date.'}, {'measure': 'Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes', 'timeFrame': 'At 5 minutes', 'description': 'If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.'}, {'measure': 'Number of Participants Who Required Red Blood Cells', 'timeFrame': 'Within 29 days', 'description': 'Red blood cells are defined as including World Health Organization (WHO) DRUG terms of "Blood cells, packed human", "Blood, whole", "Red blood cells", "Red blood cells, concentrated" and "Red blood cells, leucocyte depleted".'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fibrin sealant', 'thrombin', 'fibrinogen', 'hemostasis'], 'conditions': ['Mild or Moderate Surgical Bleeding']}, 'referencesModule': {'references': [{'pmid': '26254451', 'type': 'DERIVED', 'citation': 'Gupta N, Chetter I, Hayes P, O-Yurvati AH, Moneta GL, Shenoy S, Pribble JP, Zuckerman LA. Randomized trial of a dry-powder, fibrin sealant in vascular procedures. J Vasc Surg. 2015 Nov;62(5):1288-95. doi: 10.1016/j.jvs.2015.05.038. Epub 2015 Aug 5.'}, {'pmid': '25458801', 'type': 'DERIVED', 'citation': 'Bochicchio GV, Gupta N, Porte RJ, Renkens KL, Pattyn P, Topal B, Troisi RI, Muir W, Chetter I, Gillen DL, Zuckerman LA, Frohna PA. The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis. J Am Coll Surg. 2015 Jan;220(1):70-81. doi: 10.1016/j.jamcollsurg.2014.09.019. Epub 2014 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.\n\nThe investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document\n2. Is undergoing one of the 4 surgical procedures described\n3. Is at least 18 years old at time of consent\n4. If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding\n5. If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse\n6. Has not received blood transfusion between screening and study treatment\n7. Has mild to moderate surgical bleeding\n8. Does not have intra-operative complications\n9. Has not used a topical hemostat containing thrombin prior to study treatment\n10. Has an approximate bleeding site surface area of less than or equal to 100 cm\\^2\n\nExclusion Criteria:\n\n1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors\n2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)\n3. Has known allergy to gelatin sponge\n4. Is unwilling to receive blood products\n5. Has liver enzymes appropriate for the study, considering their disease\n6. Has appropriate level of platelets per liter (PLT/L) during screening\n7. Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities during screening that are not explained by current drug treatment (e.g., warfarin, heparin)'}, 'identificationModule': {'nctId': 'NCT01527357', 'acronym': 'FINISH-3', 'briefTitle': 'A Study of Fibrocaps™ in Surgical Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis', 'orgStudyIdInfo': {'id': 'FC-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fibrocaps + Gelatin Sponge', 'description': 'Single application of Fibrocaps plus gelatin sponge.', 'interventionNames': ['Biological: Fibrocaps', 'Biological: Gelatin sponge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gelatin Sponge', 'description': 'Single application of gelatin sponge alone.', 'interventionNames': ['Biological: Gelatin sponge']}], 'interventions': [{'name': 'Fibrocaps', 'type': 'BIOLOGICAL', 'otherNames': ['PRO-0601', 'Fibrin sealant'], 'description': 'Human fibrinogen and thrombin powder, for topical administration.', 'armGroupLabels': ['Fibrocaps + Gelatin Sponge']}, {'name': 'Gelatin sponge', 'type': 'BIOLOGICAL', 'otherNames': ['Gelfoam', 'Spongostan'], 'description': 'Absorbable gelatin sponge for topical administration.', 'armGroupLabels': ['Fibrocaps + Gelatin Sponge', 'Gelatin Sponge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardio-Thoracic Surgeons, PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Vascular Interventional Specialists of Orange County', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research, LLC', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Neurological Institute', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '81303', 'city': 'Durango', 'state': 'Colorado', 'country': 'United States', 'facility': 'Spine Colorado', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Spine Group', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Orthopedics', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Borgess Research Institute', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Health System', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'William Muir MD Spine Surgery', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '100032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian Hospital/Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The University of Oklahoma - Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University Hospital & Clinics', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'University of North Texas Health Sciences Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '84070', 'city': 'Sandy City', 'state': 'Utah', 'country': 'United States', 'facility': "Physician's Research Options", 'geoPoint': {'lat': 40.59161, 'lon': -111.8841}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Overlake Hospital Medical Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99208', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Orthopaedic Specialists, P.S.', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 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{'lat': 51.58656, 'lon': 4.77596}}, {'zip': '7513 ER', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Centre Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3075 EA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '0', 'city': 'Velp', 'country': 'Netherlands', 'facility': 'Rijnstate Arnhem', 'geoPoint': {'lat': 51.995, 'lon': 5.97361}}, {'zip': 'B15 2WB', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Addenbrookes Hospital Vascular Department', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'DN2 5LT', 'city': 'Doncaster', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Doncaster Royal Infirmary', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE5 9RS', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mallinckrodt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mallinckrodt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}