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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT04178551
Description: This study did not involve an experimental intervention, nor direct intervention with patients. Therefore we did not track adverse events at the patient level.
Frequency Threshold: 0
Time Frame: The intervention for this quality improvement (QI) study was conducted at the site level. Implementation facilitation strategies promoted usual care. Adverse events were not tracked.
Study: NCT04178551
Study Brief: Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Comparison Cohort All other sites in VA not receiving CONDUIT implementation support or participating in other dedicated MOUD implementation activities during the same time period 0 None 0 0 0 0 View
Implementation Facilitation The foundation of CONDUIT's implementation activities are the structured interactions between external facilitation teams and internal facilitation teams. A core set of internal facilitation activities will be used across all facilitation teams, and external facilitation teams will use additional activities based on the needs of their sites or clinical settings. Implementation Facilitation: The foundation of CONDUIT's implementation activities are the structured interactions between external facilitation teams and internal facilitation teams. A core set of internal facilitation activities will be used across all facilitation teams, and external facilitation teams will use additional activities based on the needs of their sites or clinical settings. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):