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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT01727505
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01727505
Study Brief: Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Conventional Mechanical Ventilation Period This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation. These data represent the 24 hours of Conventional Mechanical Ventilation. None None 0 25 0 25 View
Volume Guarantee Ventilation Period This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation. These data represent the 24 hours of Volume Guarantee Ventilation. None None 1 26 0 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Increased PaCO2 requiring high frequency ventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):