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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT06269003
Description: The study used a non-systematic assessment method, where adverse events were monitored through participants' verbal reports and observing participants' behaviors. No adverse events were reported by participants or observed during the study duration.
Frequency Threshold: 0
Time Frame: Each adverse event or serious adverse event was monitored and assessed throughout the entire duration of the participant's lab visit, from the moment a participant showed up to the lab until the study completed, which lasted approximately 1 hour per participant.
Study: NCT06269003
Study Brief: Responses to Message Source and Presentation Using Psychophysiology
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Expert 1-sided During the reporting period, no adverse events were observed or reported among participants in the expert 1-sided arm. All 28 participants completed the study phase without any clinical complaints, side effects, or complications attributed to the intervention. 0 None 0 28 0 28 View
Expert 2-sided During the reporting period, no adverse events were observed or reported among participants in the expert 2-sided arm. All 28 participants completed the study phase without any clinical complaints, side effects, or complications attributed to the intervention. 0 None 0 28 0 28 View
Peer 1-sided During the reporting period, no adverse events were observed or reported among participants in the peer 1-sided arm. All 27 participants completed the study phase without any clinical complaints, side effects, or complications attributed to the intervention. 0 None 0 27 0 27 View
Peer 2-sided During the reporting period, no adverse events were observed or reported among participants in the peer 2-sided arm. All 28 participants completed the study phase without any clinical complaints, side effects, or complications attributed to the intervention. 0 None 0 28 0 28 View
Serious Events(If Any):
Other Events(If Any):