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 @ 11:00 PM
Ignite Modification Date: 2025-12-25 @ 8:29 PM
NCT ID: NCT00391469
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00391469
Study Brief: Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention-hypo Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline None None 547 688 0 688 View
Control-standard Care standard care None None 513 671 0 671 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Re-arrest postrandomization None Cardiac disorders None View
Use of pressers post randomization None Cardiac disorders None View
prehospital deaths None Cardiac disorders None View
death in emergency dept. None Cardiac disorders None View
use of diuretics first 12 h None Cardiac disorders None View
pulmonary edema on first chest X-ray None Cardiac disorders None View
Other Events(If Any):