Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01422304
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': "Initial public presentation of the Investigator's results will occur only together with the other sites unless permission is obtained from Sponsor. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. In case of disagreement concerning appropriateness of materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues, prior to submission for publication/presentation.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days post study drug administration', 'description': 'Adverse event tables include participants in APaT population', 'eventGroups': [{'id': 'EG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.', 'otherNumAtRisk': 596, 'otherNumAffected': 491, 'seriousNumAtRisk': 596, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).', 'otherNumAtRisk': 588, 'otherNumAffected': 499, 'seriousNumAtRisk': 588, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 75, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 74, 'numAffected': 74}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 129, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 148, 'numAffected': 146}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 138, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 154, 'numAffected': 139}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 67, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 74, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 55, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 50, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 112, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 124, 'numAffected': 101}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 64, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 66, 'numAffected': 65}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 224, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 259, 'numAffected': 234}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 47, 'numAffected': 45}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 84, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 60, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 55, 'numAffected': 54}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 90, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 86, 'numAffected': 84}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 38, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 61, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 54, 'numAffected': 53}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tooth loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Femoral nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Incision site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Postoperative wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral nerve lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Reversible ischaemic neurological deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Supportive care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 596, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 588, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.29', 'estimateComment': 'Relative risk is Sugammadex versus Usual Care', 'groupDescription': 'Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance \\< or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin \\[LMWH\\], including unfractionated heparin \\[UFH\\], or not including either LMWH or UFH)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 hours post study drug administration', 'description': 'Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a "suspected, unanticipated adverse event of bleeding" (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant\'s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'title': '10 minutes (Sugammadex n=525, Usual Care n=507)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '22.4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '5.9'}, {'value': '-0.1', 'spread': '13.6', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '0.4'}]}]}, {'title': '60 minutes (Sugammadex n=523, Usual Care n=505)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '22.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (GMR) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '3.7', 'ciUpperLimit': '7.3', 'estimateComment': 'Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \\[GMR - 1\\]\\*100).', 'groupDescription': 'Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \\< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR (%)', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '2.8', 'estimateComment': 'Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \\[GMR - 1\\]\\*100).', 'groupDescription': 'Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \\< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 and 60 minutes post study drug administration', 'description': 'Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in APaT population who had baseline and at least one post baseline aPTT measurement within defined assessment window (10 or 60 minutes post study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'title': '10 minutes (Sugammadex n=526, Usual Care n=507)', 'categories': [{'measurements': [{'value': '8.0', 'spread': '63.4', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': '60 minutes (Sugammadex n=524, Usual Care n=505)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '79.8', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '23.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '1.3', 'ciUpperLimit': '4.7', 'estimateComment': 'Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \\[GMR - 1\\]\\*100).', 'groupDescription': 'Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \\< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.9', 'estimateComment': 'Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \\[GMR - 1\\]\\*100).', 'groupDescription': 'Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \\< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 and 60 minutes post study drug administration', 'description': "Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = \\[PT-Test/PT-Normal\\]\\^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in APaT population who had baseline and at least one post baseline PT(INR) measurement within defined assessment window (10 or 60 minutes post study drug).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '1.8', 'estimateComment': 'Risk difference (%) = Sugammadex incidence - Usual Care incidence', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a "suspected, unanticipated adverse event of bleeding" (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant\'s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '0.5', 'estimateComment': 'Risk difference (%) = Sugammadex incidence - Usual Care incidence', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 hours post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '1.2', 'estimateComment': 'Risk difference (%) = Sugammadex incidence - Usual Care incidence', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.5', 'estimateComment': 'Risk difference (%) = Sugammadex incidence - Usual Care incidence', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postoperative Drainage Volume Within 24 Hours After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '464', 'spread': '367.5', 'groupId': 'OG000'}, {'value': '476', 'spread': '375.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-45.0', 'ciUpperLimit': '30.5', 'estimateComment': 'Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.', 'groupDescription': 'Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.', 'statisticalMethod': 'Generalized Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post study drug administration', 'description': 'The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Requiring Any Postoperative Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '2.0', 'estimateComment': 'Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site', 'groupDescription': 'Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From end of study drug administration through approximately 120 hours after study drug administration', 'description': 'The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous \\[i.e., predose\\] transfusion for participants who had received a previous transfusion) was determined.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Transfusion Volume in Participants Who Required Postoperative Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '335', 'spread': '74', 'groupId': 'OG000'}, {'value': '345', 'spread': '84.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.24', 'estimateComment': 'GMR is Sugammadex versus Usual Care', 'groupDescription': 'Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.', 'statisticalMethod': 'Generalized Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From end of study drug administration through approximately 120 hours after study drug administration', 'description': 'Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous \\[i.e., predose\\] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to "normal" volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume.', 'unitOfMeasure': 'mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in APaT population who received a transfusion unit that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous \\[i.e., predose\\] transfusion for participants who had received a previous transfusion)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postoperative Changes in Hgb Concentrations Using the Bleeding Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.7', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '-17.4', 'spread': '17.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '3.1', 'estimateComment': 'Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.', 'groupDescription': 'Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.', 'statisticalMethod': 'Generalized Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Visit 3 (24-48 hours post study drug administration)', 'description': 'The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 - Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '3.1', 'estimateComment': 'Risk difference (%) = Sugammadex incidence - Usual Care incidence', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 hours post study drug administration', 'description': 'This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized', 'groupId': 'FG000', 'numSubjects': '598'}, {'comment': 'Randomized', 'groupId': 'FG001', 'numSubjects': '600'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '595'}, {'comment': '1 given sugammadex; thus All Participants as Treated (APaT) Ns are 596 Sugammadex, 588 Usual Care', 'groupId': 'FG001', 'numSubjects': '589'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '574'}, {'groupId': 'FG001', 'numSubjects': '563'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Never Entered Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Did Not Meet Protocol Eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '1184', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugammadex', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of neostigmine/glycopyrrolate \\[or neostigmine/atropine\\] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline \\[NaCl 0.9%\\] to match volume of sugammadex that would have been administered).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '66.7', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '326', 'groupId': 'BG000'}, {'value': '340', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Activated Partial Thromboplastin Time (aPTT)', 'classes': [{'categories': [{'measurements': [{'value': '31.14', 'spread': '4.38', 'groupId': 'BG000'}, {'value': '31.01', 'spread': '4.14', 'groupId': 'BG001'}, {'value': '31.08', 'spread': '4.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'n=556, 535, 1091 for Sugammadex, Usual Care and Total, respectively', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prothrombin Time (International Normalized Ratio) (PT[INR])', 'classes': [{'categories': [{'measurements': [{'value': '1.121', 'spread': '0.159', 'groupId': 'BG000'}, {'value': '1.114', 'spread': '0.132', 'groupId': 'BG001'}, {'value': '1.117', 'spread': '0.147', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'n=557, 535, 1092 for Sugammadex, Usual Care and Total, respectively', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2012-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2011-08-22', 'resultsFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-19', 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative Drainage Volume Within 24 Hours After Study Drug Administration', 'timeFrame': 'Up to 24 hours post study drug administration', 'description': 'The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.'}, {'measure': 'Number of Participants Requiring Any Postoperative Transfusion', 'timeFrame': 'From end of study drug administration through approximately 120 hours after study drug administration', 'description': 'The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous \\[i.e., predose\\] transfusion for participants who had received a previous transfusion) was determined.'}, {'measure': 'Total Transfusion Volume in Participants Who Required Postoperative Transfusion', 'timeFrame': 'From end of study drug administration through approximately 120 hours after study drug administration', 'description': 'Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous \\[i.e., predose\\] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to "normal" volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume.'}, {'measure': 'Postoperative Changes in Hgb Concentrations Using the Bleeding Index', 'timeFrame': 'Baseline and Visit 3 (24-48 hours post study drug administration)', 'description': 'The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 - Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline.'}, {'measure': 'Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration', 'timeFrame': 'Up to 72 hours post study drug administration', 'description': 'This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration', 'timeFrame': 'Up to 24 hours post study drug administration', 'description': 'Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a "suspected, unanticipated adverse event of bleeding" (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant\'s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration', 'timeFrame': 'Baseline, 10 and 60 minutes post study drug administration', 'description': 'Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood.'}, {'measure': 'Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration', 'timeFrame': 'Baseline, 10 and 60 minutes post study drug administration', 'description': "Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = \\[PT-Test/PT-Normal\\]\\^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood."}, {'measure': 'Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a "suspected, unanticipated adverse event of bleeding" (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant\'s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding.'}, {'measure': 'Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration', 'timeFrame': 'Up to 24 hours post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.'}, {'measure': 'Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.'}, {'measure': 'Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis).'}, {'measure': 'Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration', 'timeFrame': 'Up to 14 days post study drug administration', 'description': 'This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neuromuscular Blockade', 'Arthroplasty, Replacement, Hip', 'Arthroplasty, Replacement, Knee', 'Blood Coagulation', 'Antithrombotic Agents']}, 'referencesModule': {'references': [{'pmid': '25208233', 'type': 'RESULT', 'citation': 'Rahe-Meyer N, Fennema H, Schulman S, Klimscha W, Przemeck M, Blobner M, Wulf H, Speek M, McCrary Sisk C, Williams-Herman D, Woo T, Szegedi A. Effect of reversal of neuromuscular blockade with sugammadex versus usual care on bleeding risk in a randomized study of surgical patients. Anesthesiology. 2014 Nov;121(5):969-77. doi: 10.1097/ALN.0000000000000424.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on coagulation parameters in participants undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular blockage induced by rocuronium or vecuronium.', 'detailedDescription': 'Participants will be randomized to sugammadex or usual care in a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be American Society of Anesthesiologists (ASA) Class 1, 2, or 3\n* Must be scheduled for a hip fracture surgery or joint (hip or knee) replacement surgery under general anesthesia including the use of rocuronium or vecuronium for neuromuscular blockade\n* Must be:\n\n * Currently receiving thromboprophylactic (anti-clotting) therapy with low molecular weight heparin (LMWH) or unfractionated heparin (UFH), or\n * Planned to initiate thromboprophylactic therapy with LMWH or UFH prior to or during surgery, or\n * Currently receiving ongoing thromboprophylactic therapy with a vitamin K antagonist that has been temporarily substituted with peri-operative LMWH or UFH, and/or\n * Currently receiving ongoing thromboprophylactic therapy with low-dose aspirin or other antiplatelet therapy\n* Platelet count above the lower limit of normal range\n* Appropriate candidate for rapid reversal of neuromuscular blockade\n* Sexually active females must agree to use a medically accepted method of contraception through seven days after receiving protocol-specified medication\n\nExclusion Criteria:\n\n* Anatomical malformations that may lead to difficult intubation\n* Neuromuscular disorder that may affect neuromuscular blockade\n* History of a coagulation disorder, bleeding diathesis, systemic lupus erythematosus or antiphospholipid syndrome\n* History or evidence of active abnormal bleeding or blood clotting within 30 days prior to screening\n* Significant hepatic dysfunction\n* Severe renal insufficiency\n* History or family history of malignant hyperthermia\n* Hypersensitivity or hypersensitivity-like reaction to sugammadex, muscle relaxants, or other medications used during general anesthesia\n* Planned intravenous administration of toremifene and/or fusidic acid within 24 hours before or within 24 hours after study medication\n* Recent, severe trauma\n* Body Mass Index (BMI) \\> 35\n* Any contraindication to administration of sugammadex or neostigmine/glycopyrrolate (or neostigmine/atropine)\n* Pregnant or intends to become pregnant between randomization and the Day 30 follow-up visit\n* Breast-feeding\n* Previously treated with sugammadex or participated in a sugammadex clinical trial\n* Has an active hip/knee infection and is scheduled for revision surgery'}, 'identificationModule': {'nctId': 'NCT01422304', 'briefTitle': 'Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Controlled, Parallel-group, Double-blind Trial of Sugammadex or Usual Care (Neostigmine or Spontaneous Recovery) for Reversal of Rocuronium- or Vecuronium-induced Neuromuscular Blockade in Patients Receiving Thromboprophylaxis and Undergoing Hip Fracture Surgery or Joint (Hip/Knee) Replacement (Protocol No. P07038)', 'orgStudyIdInfo': {'id': 'P07038'}, 'secondaryIdInfos': [{'id': '2011-001201-27', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-8616-059', 'type': 'OTHER', 'domain': 'Merck protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex', 'description': 'Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive sugammadex and placebo to neostigmine, and participants assigned to planned spontaneous recovery will receive sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure.', 'interventionNames': ['Drug: Sugammadex', 'Drug: Placebo to neostigmine']}, {'type': 'EXPERIMENTAL', 'label': 'Usual Care', 'description': 'Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive neostigmine and placebo to sugammadex, and participants assigned to planned spontaneous recovery will receive placebo to sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure.', 'interventionNames': ['Drug: neostigmine and glycopyrrolate or atropine', 'Drug: Placebo to sugammadex']}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'otherNames': ['SCH 900616, MK-8616'], 'description': 'Sugammadex 4 mg/kg intravenously', 'armGroupLabels': ['Sugammadex']}, {'name': 'neostigmine and glycopyrrolate or atropine', 'type': 'DRUG', 'description': 'Neostigmine and glycopyrrolate or neostigmine and atropine administered intravenously per usual practice and per the product labels', 'armGroupLabels': ['Usual Care']}, {'name': 'Placebo to neostigmine', 'type': 'DRUG', 'description': 'Normal saline (NaCl 0.9%)', 'armGroupLabels': ['Sugammadex']}, {'name': 'Placebo to sugammadex', 'type': 'DRUG', 'description': 'Normal saline (NaCl 0.9%)', 'armGroupLabels': ['Usual Care']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}