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 @ 4:13 PM
Ignite Modification Date: 2025-12-25 @ 2:12 PM
NCT ID: NCT04331366
Description: Participants were assessed for the following adverse events: * Decreased oxygen saturation * Increased respiratory rate * Increased heart rate * Low blood pressure * Increased work of breathing * Worsening arterial blood gases (if available) * Inability to tolerate the mouthpiece
Frequency Threshold: 0
Time Frame: Participants were assessed for adverse events on the day of the intervention beginning just prior to treatment with the mouthpiece through 15 minutes after the cessation of PEEP therapy, for a total of up to 30 minutes.
Study: NCT04331366
Study Brief: Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GO2 PEEP MOUTHPIECE Participants receiving treatment with the GO2 PEEP MOUTHPIECE. 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decrease in oxygen saturation after cessation of PEEP therapy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View