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: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT04363320
Description: None
Frequency Threshold: 0
Time Frame: up to 24 months
Study: NCT04363320
Study Brief: Fostering MAT Use in Justice Populations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High-Dose NIATx Coaching & ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team * Prescribers participate in 12 monthly (one-hour) scheduled video conference calls 0 None 0 78 0 78 View
Low-Dose NIATx Coaching & ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team * Prescribers participate in 12 monthly (one-hour) scheduled video conference calls 0 None 0 65 0 65 View
High-Dose NIATx Coaching & No ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team 1 None 0 60 0 60 View
Low-Dose NIATx Coaching & No ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team 0 None 0 53 0 53 View
Serious Events(If Any):
Other Events(If Any):