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 @ 7:36 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT06682403
Description: No adverse event data were collected for this study. Adverse event monitoring was not part of the study design.
Frequency Threshold: 0
Time Frame: None
Study: NCT06682403
Study Brief: Distribution and Randomization of Gun Safety Devices to Measure Uptake and Preferences
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Individual Has a Choice Between Cable Lock and Lock Box Participants in this arm are randomized into it based on NOT taking a cable lock at the hospital when offered AND fill out the survey OR are randomized into this group by filling out the study survey linked in study materials. Choice between cable lock or lock box: Participant will have the option to select a lock box or cable lock shipped to their address after filling out the study survey. 0 None 0 0 0 0 View
Individual Receives Cable Lock as Default Participants in this arm are either automatically assigned due to taking a cable lock at the hospital when offered AND fill out the survey OR are randomized into this group by filling out the study survey linked in study materials. Received cable lock as default: Participants will receive a cable lock as the default safety device option after filling out the survey. If the participant took a cable lock during their hospital visit and noted this in the survey, they will not be shipped a cable lock. If participants did not take a cable lock and noted this in the survey, they will be shipped a cable lock. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):