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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:01 AM
NCT ID: NCT02443402
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected through hospital discharge (up to 30 days).
Study: NCT02443402
Study Brief: Sitagliptin in Non-Diabetic Patients 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
Sitagliptin Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin. 0 None 9 32 22 32 View
Placebo Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo. 0 None 7 28 15 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Surgical Site Bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View