Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
NCT ID:
NCT03861767
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.
The 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.
Frequency Threshold:
1
Time Frame:
From the time the participant is prescribed the study drug until 90 days after surgery.
Study:
NCT03861767
Study Brief:
REMAP Trial for Optimizing Surgical Outcomes at UPMC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SPRY: Metformin LD-IC (Low-dose, Intermediate Course) | LD-IC (low-dose, intermediate course) Participants 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. Metformin ER: tablet | 0 | None | 5 | 20 | 5 | 20 | View |
| SPRY: Metformin LD-LC (Low-dose, Long Course) | LD-LC (low-dose, long course) Participants 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. Metformin ER: tablet | 0 | None | 2 | 5 | 2 | 5 | View |
| SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) | ID-IC (intermediate-dose, intermediate course) Participants 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. Metformin ER: tablet | 0 | None | 6 | 19 | 5 | 19 | View |
| SPRY: Metformin ID-LC (Intermediate-dose, Long Course) | ID-LC (intermediate-dose, long course) Participants 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. Metformin ER: tablet | 0 | None | 2 | 8 | 2 | 8 | View |
| SPRY: Metformin HD-SC (High-dose, Short Course) | HD-SC (high-dose, short course) After 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. Metformin ER: tablet | 0 | None | 12 | 40 | 11 | 40 | View |
| SPRY: Metformin HD-IC (High-dose, Intermediate Course) | HD-IC (high-dose, intermediate course) After 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. Metformin ER: tablet | 0 | None | 4 | 26 | 3 | 26 | View |
| SPRY: Placebo | Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course. Placebo: Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms. | 0 | None | 12 | 106 | 10 | 106 | View |
| SPRY: Metformin LD-SC (Low-dose, Short Course) | LD-SC (low-dose, short course) Participants 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. Metformin ER: tablet | 0 | None | 11 | 39 | 10 | 39 | View |
| SPRY: Metformin ID-SC (Intermediate-dose, Short Course) | ID-SC (intermediate-dose, short course) Participants 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. Metformin ER: tablet | 1 | None | 10 | 39 | 9 | 39 | View |
| SPRY: Metformin HD-LC (High-dose, Long Course) | HD-LC (high-dose, long course) After 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. Metformin ER: tablet | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| From time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Time of prescription until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Time of prescription of study drug until 90 days after surgery | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |