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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT01592760
Description: Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.
Frequency Threshold: 0
Time Frame: Up to 24 hours post-device use
Study: NCT01592760
Study Brief: Air-Q® SP Versus Air-Q® and I-gel: A Randomized Clinical Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Air-Q SP Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia. None None 0 90 1 90 View
I-gel Subjects randomized to receive an I-gel for airway maintenance under general anesthesia. None None 0 45 1 45 View
Air-Q Subjects randomized to receive air-Q for airway maintenance under general anesthesia. None None 0 90 1 90 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lip swelling/bruise SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Oropharyngeal bruise SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Oropharyngeal heme/blood SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View