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 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
NCT ID: NCT04258020
Description: All patients were assessed for adverse events through hospital discharge
Frequency Threshold: 0
Time Frame: Through hospital discharge, and average of 10.9 days.
Study: NCT04258020
Study Brief: Postextubation Management in Patients at Risk for Extubation Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: Alternating BiPAP and HFNC Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration 0 None 0 3 1 3 View
Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View