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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT00351533
Description: None
Frequency Threshold: 5
Time Frame: 28 days from day of study enrollment
Study: NCT00351533
Study Brief: A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enteral Fish Oil 7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily None None 12 41 24 41 View
Enteral Saline 7.5cc 0.9% saline every 6 hours None None 10 49 27 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation with rapid ventricular response None Cardiac disorders None View
Renal failure requiring renal replacement therapy None Renal and urinary disorders None View
Pleural and pericardial effusions None Respiratory, thoracic and mediastinal disorders None View
Critical hypoxemia None Respiratory, thoracic and mediastinal disorders None View
Trombocytopenia None Blood and lymphatic system disorders None View
Fulminant liver failure None Hepatobiliary disorders None View
Right eye blindness after prolonged prone surgery None Eye disorders None View
Recurrent falls None Nervous system disorders None View
Aspiration with reintubation None Respiratory, thoracic and mediastinal disorders None View
Pneumothorax None Respiratory, thoracic and mediastinal disorders None View
Nosocomial sepsis None Infections and infestations None View
PEA arrest None Cardiac disorders None View
Erythema multiforme minor None Skin and subcutaneous tissue disorders None View
Delayed spinal cord contusion and injury None Nervous system disorders None View
Severe hypotension None Vascular disorders None View
Pericardial tamponade None Cardiac disorders None View
Retroperitoneal hematoma None Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Total Infections None Infections and infestations None View