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 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT01504867
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT01504867
Study Brief: LIPS-A: Lung Injury Prevention Study With Aspirin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aspirin This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7. None None 4 195 13 195 View
Placebo This group received matching lactose powder filled capsules on days 1-7. None None 8 195 5 195 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia/Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bleeding Stress Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia due to Upper GI Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Low Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pulseless Electrical Activity SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Skin Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastrointestinal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cerebral Hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mild Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NSTEMI SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nose Bleed SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rectal Bleeding SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Right Hip Resection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urosepsis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Low Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Renal Failure Requiring Dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated Blood Pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View