Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT03861767
Status:
TERMINATED
Last Update Posted:
2024-06-18
First Post:
2019-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
REMAP Trial for Optimizing Surgical Outcomes at UPMC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nealm2@upmc.edu', 'phone': '412-647-1158', 'title': 'Matthew D. Neal, MD FACS', 'organization': 'UPMC'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Recruitment was terminated early and was limited by the COVID-19 pandemic, as such the study is underpowered and could not meet its set goals. No patients fell in the high dose long course group since no participants were randomized to that group'}}, 'adverseEventsModule': {'timeFrame': 'From the time the participant is prescribed the study drug until 90 days after surgery.', 'description': 'There is a category with no participants. The total number of participants at risk is different here because adverse events were monitored for all patients while the measure outcomes were only reported for participants that underwent an operation.\n\nThe numbers from this outcome will never match the numbers from outcome 13 since the reporting description is different. e.i a participant can have an AE in multiple systems but are all unrelated; will be counted here several times but there once.', 'eventGroups': [{'id': 'EG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 10, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 9, 'seriousNumAtRisk': 39, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 5, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 11, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 3, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 10, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription of study drug until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'From time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Time of prescription until 90 days after surgery', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Free Days (HFD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '84.8', 'upperLimit': '89.2'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '86.8', 'upperLimit': '90'}, {'value': '85', 'groupId': 'OG002', 'lowerLimit': '84', 'upperLimit': '85'}, {'value': '88', 'groupId': 'OG003', 'lowerLimit': '85', 'upperLimit': '90'}, {'value': '88', 'groupId': 'OG004', 'lowerLimit': '86.5', 'upperLimit': '90'}, {'value': '89.5', 'groupId': 'OG005', 'lowerLimit': '89', 'upperLimit': '90'}, {'value': '88', 'groupId': 'OG006', 'lowerLimit': '85', 'upperLimit': '90'}, {'value': '87', 'groupId': 'OG007', 'lowerLimit': '84', 'upperLimit': '90'}, {'value': '87', 'groupId': 'OG009', 'lowerLimit': '85', 'upperLimit': '90'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.97', 'groupDescription': 'Low dose groups collapsed and compared to placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004', 'OG005', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.25', 'groupDescription': 'Intermediate dose groups were collapsed and compared to placebo', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.84', 'groupDescription': 'High dose groups were collapsed and compared to placebo', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'description': '90 - the number of days during the index stay minus the number of days readmitted during the 90 days after surgery. Death within 90 days after surgery is recorded as -1 HFD.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-treat analysis. Participants that did not undergo an operation were excluded.'}, {'type': 'SECONDARY', 'title': 'Incidence of ICU Admission After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.52', 'ciUpperLimit': '2.03', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed', 'description': 'The intended measure of this outcome is to get the rate of ICU admission per described group or the number of participants that had an ICU admission within each group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed using intention-to-treat analysis. Participants that did not undergo surgery were excluded'}, {'type': 'SECONDARY', 'title': 'Incidence and Total Number of Reoperation/Reintervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.52', 'ciUpperLimit': '2.00', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'description': 'This outcome is also intended to measure the rate of Reoperation/reintervention within each group or the total number of participants that had a Reoperation/reintervention within each group as shown below', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.49', 'ciUpperLimit': '3.11', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'description': 'The intended measure from this outcome is to also show the rate of Venous thromboembolic events or the number of participants with Venous thromboembolic events within each group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.73', 'ciUpperLimit': '3.62', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30 from the date of the elective surgical procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Site Occurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.71', 'ciUpperLimit': '2.86', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30 from the date of the elective surgical procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'Organ Failure Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.84', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '29.93', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '29.97', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '29.96', 'spread': '0.04', 'groupId': 'OG003'}, {'value': '29.86', 'spread': '0.32', 'groupId': 'OG004'}, {'value': '29.98', 'spread': '0.02', 'groupId': 'OG005'}, {'value': '29.88', 'spread': '0.50', 'groupId': 'OG006'}, {'value': '29.94', 'spread': '0.21', 'groupId': 'OG007'}, {'value': '29.90', 'spread': '0.27', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Beta-coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0011', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.042', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30 from the date of the elective surgical procedure', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '4.00', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '4.1', 'groupId': 'OG003'}, {'value': '2.6', 'spread': '3.4', 'groupId': 'OG004'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG005'}, {'value': '4.3', 'spread': '6.7', 'groupId': 'OG006'}, {'value': '3.3', 'spread': '3.2', 'groupId': 'OG007'}, {'value': '4.2', 'spread': '7.4', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Beta-coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.74', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'ICU (Intensive Care Unit) Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG005'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG006'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG007'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Beta-coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'groupDescription': 'All intervention groups were grouped together and compared to placebo', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded. Only one mortality was observed and thus no statistical analysis was performed'}, {'type': 'SECONDARY', 'title': 'Hospital Readmission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.74', 'ciUpperLimit': '2.86', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Intolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '40', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '106', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.98', 'ciLowerLimit': '1.19', 'ciUpperLimit': '7.44', 'groupDescription': 'All intervention groups were collapsed and compared to placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to day 90 after surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants included. Group with zero participants added for completion'}, {'type': 'SECONDARY', 'title': 'SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '40', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '106', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'title': 'Mild - related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Mild- possibly related', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}]}, {'title': 'Mild - unrelated', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}, {'title': 'Moderate - related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Moderate- possibly related', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Moderate - unrelated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}, {'title': 'Severe - related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Severe- possibly related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Severe - unrelated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'life threatening/disabling - related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'life threatening/disabling - possibly related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'life threatening/disabling - unrelated', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.67', 'ciLowerLimit': '1.34', 'ciUpperLimit': '5.30', 'groupDescription': 'All intervention groups were collapsed and compared to placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to day 90 after surgery', 'description': 'The number of participants here includes the full cohort because adverse events were recorded for all participants while other outcome measures were only recorded for participants that underwent surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants included. Group with zero participants included for completion'}, {'type': 'SECONDARY', 'title': 'Discharge Disposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'title': 'Home', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '85', 'groupId': 'OG009'}]}, {'title': 'Skilled nursing facility/Rehabilitation facility', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}]}, {'title': 'Death/Hospice', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}, {'title': 'Missing data', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.56', 'groupDescription': 'All intervention groups were collapsed into one group and compared with placebo. Patients were compared whether they were discharged home or other.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded'}, {'type': 'SECONDARY', 'title': 'In Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'OG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed using intention-to-trial analysis. Participants that did not undergo an operation were excluded. No in-hospital mortalities were observed and hence no statistical analysis was performed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'FG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '40'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '106'}]}, {'type': 'Underwent Surgery', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '38'}, {'groupId': 'FG007', 'numSubjects': '23'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '98'}]}, {'type': 'Drug Compliance', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '35'}, {'groupId': 'FG007', 'numSubjects': '21'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'comment': 'This total number is for intention-to-treat group. Per-Protocol group is the compliant group - (the group that did not undergo surgery + group that withdrew)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '37'}, {'groupId': 'FG007', 'numSubjects': '25'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '106', 'groupId': 'BG009'}, {'value': '302', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'SPRY: Metformin LD-SC (Low-dose, Short Course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG001', 'title': 'SPRY: Metformin LD-IC (Low-dose, Intermediate Course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG002', 'title': 'SPRY: Metformin LD-LC (Low-dose, Long Course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG003', 'title': 'SPRY: Metformin ID-SC (Intermediate-dose, Short Course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG004', 'title': 'SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG005', 'title': 'SPRY: Metformin ID-LC (Intermediate-dose, Long Course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG006', 'title': 'SPRY: Metformin HD-SC (High-dose, Short Course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG007', 'title': 'SPRY: Metformin HD-IC (High-dose, Intermediate Course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG008', 'title': 'SPRY: Metformin HD-LC (High-dose, Long Course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.\n\nMetformin ER: tablet"}, {'id': 'BG009', 'title': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.\n\nPlacebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '37', 'groupId': 'BG009'}, {'value': '95', 'groupId': 'BG010'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '69', 'groupId': 'BG009'}, {'value': '207', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '70.8', 'spread': '5.1', 'groupId': 'BG002'}, {'value': '67.7', 'spread': '7.3', 'groupId': 'BG003'}, {'value': '68.6', 'spread': '8.4', 'groupId': 'BG004'}, {'value': '71.1', 'spread': '5.8', 'groupId': 'BG005'}, {'value': '67.5', 'spread': '8.2', 'groupId': 'BG006'}, {'value': '70.2', 'spread': '6.5', 'groupId': 'BG007'}, {'value': '67.8', 'spread': '5.7', 'groupId': 'BG009'}, {'value': '68.4', 'spread': '6.7', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '50', 'groupId': 'BG009'}, {'value': '134', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '56', 'groupId': 'BG009'}, {'value': '168', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '106', 'groupId': 'BG009'}, {'value': '295', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '15', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '101', 'groupId': 'BG009'}, {'value': '279', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '30.9', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '4.2', 'groupId': 'BG002'}, {'value': '30.9', 'spread': '5.9', 'groupId': 'BG003'}, {'value': '28.0', 'spread': '4.6', 'groupId': 'BG004'}, {'value': '26.2', 'spread': '5.1', 'groupId': 'BG005'}, {'value': '30.5', 'spread': '10.7', 'groupId': 'BG006'}, {'value': '30.6', 'spread': '6.6', 'groupId': 'BG007'}, {'value': '30.2', 'spread': '6.4', 'groupId': 'BG009'}, {'value': '30.3', 'spread': '6.7', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Risk analysis index score', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '25.2', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '31.0', 'spread': '13.5', 'groupId': 'BG002'}, {'value': '25.6', 'spread': '5.5', 'groupId': 'BG003'}, {'value': '22.8', 'spread': '3.5', 'groupId': 'BG004'}, {'value': '24.2', 'spread': '2.3', 'groupId': 'BG005'}, {'value': '25.5', 'spread': '7.4', 'groupId': 'BG006'}, {'value': '26.1', 'spread': '4.6', 'groupId': 'BG007'}, {'value': '25.8', 'spread': '6.4', 'groupId': 'BG009'}, {'value': '25.8', 'spread': '6.3', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'This is a measure of frailty. Score is prospectively calculated during the preoperative visit and is a score that ranges from 0-81. 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'9', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '34', 'groupId': 'BG009'}, {'value': '82', 'groupId': 'BG010'}]}]}, {'title': 'General surgery/Oncological surgery', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '33', 'groupId': 'BG009'}, {'value': '107', 'groupId': 'BG010'}]}]}, {'title': 'Colorectal surgery', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '36', 'groupId': 'BG010'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}, {'value': '57', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'None of the participants were randomized to the high-dose long course combination of drug dose and preoperative duration.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-17', 'size': 537592, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-06T16:04', 'hasProtocol': True}, {'date': '2023-09-06', 'size': 582372, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-05T12:19', 'hasProtocol': False}, {'date': '2021-09-22', 'size': 263316, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-05T13:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'whyStopped': 'Not enough enrollment due to the COVID19 pandemic.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'dispFirstSubmitDate': '2023-09-08', 'completionDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2019-01-21', 'resultsFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2019-02-28', 'dispFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-24', 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Free Days (HFD)', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'description': '90 - the number of days during the index stay minus the number of days readmitted during the 90 days after surgery. Death within 90 days after surgery is recorded as -1 HFD.'}], 'secondaryOutcomes': [{'measure': 'Incidence of ICU Admission After Surgery', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed', 'description': 'The intended measure of this outcome is to get the rate of ICU admission per described group or the number of participants that had an ICU admission within each group.'}, {'measure': 'Incidence and Total Number of Reoperation/Reintervention', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'description': 'This outcome is also intended to measure the rate of Reoperation/reintervention within each group or the total number of participants that had a Reoperation/reintervention within each group as shown below'}, {'measure': 'Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism', 'timeFrame': 'Day 90 from the date of the elective surgical procedure', 'description': 'The intended measure from this outcome is to also show the rate of Venous thromboembolic events or the number of participants with Venous thromboembolic events within each group'}, {'measure': 'Number of Participants With Surgical Site Infection', 'timeFrame': 'Day 30 from the date of the elective surgical procedure'}, {'measure': 'Number of Participants With Surgical Site Occurrence', 'timeFrame': 'Day 30 from the date of the elective surgical procedure'}, {'measure': 'Organ Failure Free Days', 'timeFrame': 'Day 30 from the date of the elective surgical procedure'}, {'measure': 'Hospital Length of Stay (LOS)', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days'}, {'measure': 'ICU (Intensive Care Unit) Length of Stay (LOS)', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed'}, {'measure': 'Mortality', 'timeFrame': 'Day 90 from the date of the elective surgical procedure'}, {'measure': 'Hospital Readmission Rate', 'timeFrame': 'Day 90 from the date of the elective surgical procedure'}, {'measure': 'Gastrointestinal Intolerance', 'timeFrame': 'From enrollment to day 90 after surgery'}, {'measure': 'SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)', 'timeFrame': 'From enrollment to day 90 after surgery', 'description': 'The number of participants here includes the full cohort because adverse events were recorded for all participants while other outcome measures were only recorded for participants that underwent surgery'}, {'measure': 'Discharge Disposition', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed'}, {'measure': 'In Hospital Mortality', 'timeFrame': 'Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '32994242', 'type': 'DERIVED', 'citation': 'Reitz KM, Seymour CW, Vates J, Quintana M, Viele K, Detry M, Morowitz M, Morris A, Methe B, Kennedy J, Zuckerbraun B, Girard TD, Marroquin OC, Esper S, Holder-Murray J, Newman AB, Berry S, Angus DC, Neal M. Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients. BMJ Open. 2020 Sep 29;10(9):e037690. doi: 10.1136/bmjopen-2020-037690.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to determine the effect of various interventions to improve patient outcome as defined by hospital free days at day 90 for adult patients undergoing elective surgery. Within this project, multiple studies may be conducted.\n\nThe structure of this project permits:\n\n* the testing of multiple treatments at the same time within the same patient\n* the use of early study results to provide better treatment options to future patients\n* the removal of treatments which are shown to be less effective than the other treatments\n* the addition of new treatments\n\nThe first study to be conducted under this project (IRB STUDY19090186) is the Strategies to Promote ResiliencY (SPRY) clinical trial (IRB PRO18060038).\n\nThe SPRY clinical trial will determine the effectiveness of Metformin on improving surgical outcomes among nondiabetic older adults who are scheduled for elective surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'UPMC REMAP\n\nInclusion Criteria:\n\n* Adult patient evaluated pre-operatively for elective surgery at UPMC\n* Minimum lead time before surgery to provide domain specific intervention (range 7-180 days pre-operatively)\n* Age greater to or equal to 18 years of age\n\nExclusion Criteria:\n\n* Death is deemed to be imminent or inevitable\n* Emergency surgical procedure without suitable lead-in time\n* Previous participation in this REMAP within the last 90 days, flagged by elective or emergency surgical encounter at UPMC in the past 90 days\n\nSPRY Domain\n\nInclusion Criteria:\n\n* Age \\>= 60 years\n* Age \\< 60 but evidence of comorbidity risk as represented by a Charlson Comorbidity Index of \\> 2 in 12 months prior to enrollment\n* Able to take an oral medication in non-crushable pill form\n* Women must be post-menopausal, which is defined as not having a menstrual period within the last 12 months\n\nExclusion Criteria:\n\n* The treating clinician believes that participation in the domain would not be in the best interest of the patient\n* Pre-existing diabetes type I or II\n* Women of child-bearing potential\n* Hospital stay \\<24 hours\n* Presently taking metformin or prior use in the past 6 months\n* Evidence of an absolute or relative contraindication to Metformin therapy\n\n * Known allergy to metformin\n * Acute or chronic metabolic acidosis with or without coma\n * Hemodialysis, end-stage renal disease, or Glomerular Filtration Rate (GFR) \\< 45 in the prior 30 days\n * Ongoing treatment with therapy known to have significant drug-drug interaction with metformin (carbonic anhydrase inhibitors, cimetidine, gliptins)\n * History of lactic acidosis\n * History of excessive alcohol intake\n * Severe hepatic dysfunction'}, 'identificationModule': {'nctId': 'NCT03861767', 'acronym': 'UPMCREMAP', 'briefTitle': 'REMAP Trial for Optimizing Surgical Outcomes at UPMC', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC', 'orgStudyIdInfo': {'id': 'STUDY19090186'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin LD-SC (low-dose, short course)', 'description': "LD-SC (low-dose, short course)\n\nParticipants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin LD-IC (low-dose, intermediate course)', 'description': "LD-IC (low-dose, intermediate course)\n\nParticipants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin LD-LC (low-dose, long course)', 'description': "LD-LC (low-dose, long course)\n\nParticipants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin ID-SC (intermediate-dose, short course)', 'description': "ID-SC (intermediate-dose, short course)\n\nParticipants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin ID-IC (intermediate-dose, intermediate course)', 'description': "ID-IC (intermediate-dose, intermediate course)\n\nParticipants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin ID-LC (intermediate-dose, long course)', 'description': "ID-LC (intermediate-dose, long course)\n\nParticipants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin HD-SC (high-dose, short course)', 'description': "HD-SC (high-dose, short course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin HD-IC (high-dose, intermediate course)', 'description': "HD-IC (high-dose, intermediate course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'EXPERIMENTAL', 'label': 'SPRY: Metformin HD-LC (high-dose, long course)', 'description': "HD-LC (high-dose, long course)\n\nAfter a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.", 'interventionNames': ['Drug: Metformin ER']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SPRY: Placebo', 'description': 'Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin ER', 'type': 'DRUG', 'otherNames': ['Metformin Extended Release'], 'description': 'tablet', 'armGroupLabels': ['SPRY: Metformin HD-IC (high-dose, intermediate course)', 'SPRY: Metformin HD-LC (high-dose, long course)', 'SPRY: Metformin HD-SC (high-dose, short course)', 'SPRY: Metformin ID-IC (intermediate-dose, intermediate course)', 'SPRY: Metformin ID-LC (intermediate-dose, long course)', 'SPRY: Metformin ID-SC (intermediate-dose, short course)', 'SPRY: Metformin LD-IC (low-dose, intermediate course)', 'SPRY: Metformin LD-LC (low-dose, long course)', 'SPRY: Metformin LD-SC (low-dose, short course)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.', 'armGroupLabels': ['SPRY: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Matthew D Neal, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Relevant data may be available 1 year following publication', 'ipdSharing': 'YES', 'description': 'De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.', 'accessCriteria': 'Data access is subject to a methodologically sound proposal and the necessary data sharing agreements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthew Neal MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh Medical Center', 'class': 'OTHER'}, {'name': 'Berry Consultants', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matthew Neal MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}