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 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:42 PM
NCT ID: NCT03508050
Description: None
Frequency Threshold: 0.06
Time Frame: Adverse event data were collected from the beginning of the surgery through completion of surgery. Moreover, the first PACU thoracic x-ray of each patient was analyzed by a radiologist in order to detect anomalies.
Study: NCT03508050
Study Brief: Clamping the Double Lumen Tube
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Double Lumen Tube Clamp Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation 0 None 0 20 1 15 View
Control Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation 0 None 1 17 7 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Desaturation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
X-ray anomalies SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View