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 @ 7:43 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT06228703
Description: Adverse events were monitored throughout the experimental session by direct observation. The study involved healthy volunteers undergoing brief respiratory interventions, with no clinical treatments or follow-up. No differences exist between the study's definitions of adverse events and ClinicalTrials.gov definitions.
Frequency Threshold: 0
Time Frame: From the start of the experimental session until completion of all flow conditions (up to 4 hours)
Study: NCT06228703
Study Brief: The Effects of Different Flow Settings on Lung Impedance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total Study Population This randomized crossover study assigned all participants to receive each of the study treatments in a randomized order. All 26 participants contributed baseline demographic data to this single group. 0 None 0 26 0 26 View
Serious Events(If Any):
Other Events(If Any):