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: 2025-12-24 @ 10:01 PM
Ignite Modification Date: 2025-12-25 @ 7:38 PM
NCT ID: NCT02396732
Description: For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.
Frequency Threshold: 0
Time Frame: Up to 2 months
Study: NCT02396732
Study Brief: Aspirin and Enoxaparin for VTE in Trauma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LMWH + ASA Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. 0 None 2 14 1 14 View
LMWH Alone Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. 1 None 4 17 1 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Altered Mental Status SYSTEMATIC_ASSESSMENT General disorders None View
Venous Thromboembolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View