Viewing Study NCT03346057

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Ignite Creation Date: 2025-12-24 @ 6:43 PM
Ignite Modification Date: 2025-12-29 @ 11:09 PM
Study NCT ID: NCT03346057
Status: COMPLETED
Last Update Posted: 2020-10-08
First Post: 2017-11-15
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D014673', 'term': 'Vecuronium Bromide'}], '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': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, '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': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 21 days post treatment', 'description': 'All-Cause Mortality reported for all randomized participants (N = 344: Sugammadex 2 mg/kg: n = 111, Sugammadex 4 mg/kg: n = 112, Sugammadex 16 mg/kg: n = 68, and Neostigmine + Glycopyrrolate: n = 53). Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 111, 'otherNumAffected': 89, 'seriousNumAtRisk': 105, 'deathsNumAffected': 1, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 112, 'otherNumAffected': 89, 'seriousNumAtRisk': 107, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 60, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 53, 'otherNumAffected': 41, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Postoperative hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 66, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 67, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 38, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gallbladder abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, 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0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'OG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'OG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'OG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}, {'value': '7.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '-0.8', 'groupDescription': 'Miettinen \\& Nurminen method stratified by neuromuscular blocking agent (NMBA) and American Society of Anesthesiologists (ASA) class was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.058', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '0.2', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.730', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '8.6', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 35 minutes post-administration', 'description': 'The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate \\<60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as determined by investigator judgment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'OG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'OG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'OG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '8.8', 'groupId': 'OG002'}, {'value': '21.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.9', 'ciLowerLimit': '-28.8', 'ciUpperLimit': '-4.0', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.036', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.2', 'ciLowerLimit': '-26.1', 'ciUpperLimit': '-0.8', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.158', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.9', 'ciLowerLimit': '-27.6', 'ciUpperLimit': '3.6', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 35 minutes post-administration', 'description': 'The percentage of participants experiencing treatment-emergent sinus tachycardia events was identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not have been considered an AE, as determined by investigator judgment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'OG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'OG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'OG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.637', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '4.0', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.134', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '1.5', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.577', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '5.8', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value', 'statisticalMethod': 'Stratified Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 35 minutes post-administration', 'description': 'The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'OG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'OG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'OG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}], 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '88.8', 'groupId': 'OG001'}, {'value': '92.6', 'groupId': 'OG002'}, {'value': '88.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.2', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '18.5', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '13.1', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '17.7', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days', 'description': "As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'OG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'OG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'OG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}, {'value': '5.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '14.3', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '9.3', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '12.7', 'groupDescription': 'Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days', 'description': 'As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'OG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'OG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'OG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}], 'classes': [{'title': 'With one or more ECIs', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}, {'value': '3.9', 'groupId': 'OG003'}]}]}, {'title': 'Adjudicated Hypersensitivity', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Adjudicated Anaphylaxis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Clinically Relevant Bradycardia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Clinically Relevant Tachycardia', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Other Clinically Relevant Cardiac Arrhythmia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Drug Induced Liver Injury', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '3.8', 'groupDescription': 'The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 2 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '8.4', 'groupDescription': 'The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 4 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '11.1', 'groupDescription': 'The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 16 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \\& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days', 'description': 'As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. A participant could have experienced more than one type of ECI.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'FG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'FG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'FG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Ineligible For Study - Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Renal Insufficiency - Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Randomization Mistake - Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of 344 participants randomized to the study, 331 received at least one dose of study treatment (All Treated Population) and were evaluable for all safety analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '344', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose'}, {'id': 'BG001', 'title': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose'}, {'id': 'BG002', 'title': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose'}, {'id': 'BG003', 'title': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '69.4', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '66.6', 'spread': '10.9', 'groupId': 'BG003'}, {'value': '68.5', 'spread': '11.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '135', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '209', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '332', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '325', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participant Stratifications', 'classes': [{'title': 'Rocuronium, ASA Class 3', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}]}, {'title': 'Rocuronium, ASA Class 4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}, {'title': 'Vecuronium, ASA Class 3', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}, {'title': 'Vecuronium, ASA Class 4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by neuromuscular blockade agent (NMBA, rocuronium or vecuronium) and American Society of Anesthesiologists (ASA) Class which ranges from ASA 1 (Normal healthy patient) to ASA 6 (Declared brain-dead patient whose organs are being removed for donor purposes). Higher ASA class with other factors (surgery type, frailty, and deconditioning) help predict greater perioperative risk. Participants were graded as ASA 3 if participants had severe systematic disease and as ASA 4 if participants had severe systematic disease that was a constant threat to the life.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-05', 'size': 847825, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-24T13:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2017-11-15', 'resultsFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events', 'timeFrame': 'Up to approximately 35 minutes post-administration', 'description': 'The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate \\<60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as determined by investigator judgment.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events', 'timeFrame': 'Up to approximately 35 minutes post-administration', 'description': 'The percentage of participants experiencing treatment-emergent sinus tachycardia events was identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not have been considered an AE, as determined by investigator judgment.'}, {'measure': 'Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events', 'timeFrame': 'Up to approximately 35 minutes post-administration', 'description': 'The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment.'}, {'measure': 'Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention', 'timeFrame': 'Up to 7 days', 'description': "As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE."}, {'measure': 'Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention', 'timeFrame': 'Up to 7 days', 'description': 'As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose.'}, {'measure': 'Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention', 'timeFrame': 'Up to 7 days', 'description': 'As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. A participant could have experienced more than one type of ECI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arrhythmia, bradycardia, neuromuscular blocking agents, surgery, tachycardia'], 'conditions': ['Reversal of Neuromuscular Blockade']}, 'referencesModule': {'references': [{'pmid': '34711192', 'type': 'DERIVED', 'citation': 'Herring WJ, Mukai Y, Wang A, Lutkiewicz J, Lombard JF, Lin L, Watkins M, Broussard DM, Blobner M. A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants. BMC Anesthesiol. 2021 Oct 28;21(1):259. doi: 10.1186/s12871-021-01477-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a body mass index (BMI) \\< 40 kg/m2.\n* Is categorized as ASA Physical Status Class 3 or 4, as determined by the Investigator.\n* Has a planned surgical procedure that requires NMB with either rocuronium or vecuronium.\n* Has a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case.\n* If female who is not of reproductive potential, is one of the following: (1) postmenopausal; (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; (3) has a congenital or acquired condition that prevents childbearing; or (4) is undergoing surgical sterilization (e.g., hysterectomy or tubal ligation) as the planned surgical procedure associated with participation in this study.\n* If female who is sexually active and of child-bearing potential, agrees to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Ethics Review Committees/Institutional Review Boards.\n* Is able to provide (or the participant's legally authorized representative, in accordance with local requirements), written informed consent for the trial. The participant or legally authorized representative may also provide consent for Future Biomedical Research.\n\nExclusion Criteria:\n\n* Has a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.\n* Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.\n* Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.\n* Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of \\<30 mL/min.\n* Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.\n* Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.\n* Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration.\n* Has any condition that would contraindicate the administration of study medication.\n* Is pregnant, is attempting to become pregnant, or is lactating.\n* Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial."}, 'identificationModule': {'nctId': 'NCT03346057', 'briefTitle': 'Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in American Society of Anesthesiologists (ASA) Class 3 or 4 Subjects', 'orgStudyIdInfo': {'id': '8616-145'}, 'secondaryIdInfos': [{'id': '2017-000187-15', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-8616-145', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex 2 mg/kg', 'description': 'Sugammadex 2 mg/kg administered as a single intravenous (IV) dose', 'interventionNames': ['Drug: Sugammadex 2 mg/kg', 'Drug: Rocuronium', 'Drug: Vecuronium']}, {'type': 'EXPERIMENTAL', 'label': 'Sugammadex 4 mg/kg', 'description': 'Sugammadex 4 mg/kg administered as a single IV dose', 'interventionNames': ['Drug: Sugammadex 4 mg/kg', 'Drug: Rocuronium', 'Drug: Vecuronium']}, {'type': 'EXPERIMENTAL', 'label': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg administered as a single IV dose', 'interventionNames': ['Drug: Sugammadex 16 mg/kg', 'Drug: Rocuronium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neostigmine + Glycopyrrolate', 'description': 'Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose', 'interventionNames': ['Drug: Neostigmine + Glycopyrrolate', 'Drug: Rocuronium', 'Drug: Vecuronium']}], 'interventions': [{'name': 'Sugammadex 2 mg/kg', 'type': 'DRUG', 'otherNames': ['MK-8616', 'Bridion'], 'description': 'Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex 2 mg/kg for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.', 'armGroupLabels': ['Sugammadex 2 mg/kg']}, {'name': 'Sugammadex 4 mg/kg', 'type': 'DRUG', 'otherNames': ['MK-8616', 'Bridion'], 'description': 'Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 4 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.', 'armGroupLabels': ['Sugammadex 4 mg/kg']}, {'name': 'Sugammadex 16 mg/kg', 'type': 'DRUG', 'otherNames': ['MK-8616', 'Bridion'], 'description': 'Following administration of NMBA (Rocuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 16 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.', 'armGroupLabels': ['Sugammadex 16 mg/kg']}, {'name': 'Neostigmine + Glycopyrrolate', 'type': 'DRUG', 'description': 'Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 μg/kg; 5 mg maximum) and Glycopyrrolate (10 μg/kg; 1 mg maximum) for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.', 'armGroupLabels': ['Neostigmine + Glycopyrrolate']}, {'name': 'Rocuronium', 'type': 'DRUG', 'description': "To achieve NMB, participants received steroidal NMBA Rocuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.", 'armGroupLabels': ['Neostigmine + Glycopyrrolate', 'Sugammadex 16 mg/kg', 'Sugammadex 2 mg/kg', 'Sugammadex 4 mg/kg']}, {'name': 'Vecuronium', 'type': 'DRUG', 'description': "To achieve NMB, participants received steroidal NMBA Vecuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.", 'armGroupLabels': ['Neostigmine + Glycopyrrolate', 'Sugammadex 2 mg/kg', 'Sugammadex 4 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama - Birmingham ( Site 1046)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University Banner Medical Center ( Site 1019)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center ( Site 1029)', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center ( Site 1001)', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital ( Site 1007)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center ( Site 1050)', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University ( Site 1057)', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation ( Site 1005)', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital ( Site 1039)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital, Royal Oak ( Site 1034)', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University Hospital- Columbia MO ( Site 1060)', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Health Care ( Site 1022)', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '07753', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center ( Site 1058)', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Peter's University Hospital [New Brunswick, NJ] ( Site 1017)", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital - Memorial ( Site 1016)', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clin Foundation ( Site 1032)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19140-5103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital ( Site 1004)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center ( Site 1033)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Hermann Drive Surgical Center ( Site 1021)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Zablocki VA Medical Center ( Site 1011)', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '6850', 'city': 'Dornbirn', 'state': 'Voralberg', 'country': 'Austria', 'facility': 'A.O. 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