Adverse Events Module

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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 @ 5:00 AM
Ignite Modification Date: 2025-12-26 @ 4:00 AM
NCT ID: NCT02556918
Description: None
Frequency Threshold: 0
Time Frame: one month
Study: NCT02556918
Study Brief: Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo: One pill daily starting one day prior to surgery until discharge from the hospital 1 None 69 101 5 101 View
Sitagliptin Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day. 0 None 80 100 6 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Miocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardiogenic shock NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Re-admittion to ICU NON_SYSTEMATIC_ASSESSMENT General disorders None View
Re-intubation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Surgical Site Bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Readmission due to surgical site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospital readmissions for other reasons NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Loss of appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View