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 @ 2:49 PM
Ignite Modification Date: 2025-12-25 @ 1:17 PM
NCT ID: NCT01924559
Description: Minimal risk study, N/A.
Frequency Threshold: 0
Time Frame: Minimal risk study, N/A.
Study: NCT01924559
Study Brief: Comparison of Airway Intubation Devices When Using a Biohazard Suit
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SALT & Standard Clothing Residents will intubate manikins using SALT while wearing standard clothing. standard clothing SALT None None 0 37 0 37 View
SALT and Biohazard Gear Residents will intubate manikins using SALT while wearing biohazard gear. Biohazard gear SALT No adverse events None None 0 37 0 37 View
Glidescope & Biohazard Gear Residents will intubate manikins using Glidescope while wearing Biohazard gear. Biohazard gear GlideScope None None 0 37 0 37 View
DL & Standard Clothing Residents will intubate manikin using DL while wearing standard clothing. standard clothing DL None None 0 37 0 37 View
DL & Biohazard Gear Residents will intubate manikins using DL while in Biohazard gear. Biohazard gear DL None None 0 37 0 37 View
Glidescope & Standard Clothing Residents will intubate manikins using Glidescope while wearing standard clothing. standard clothing GlideScope None None 0 37 0 37 View
Serious Events(If Any):
Other Events(If Any):