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 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT04248933
Description: None
Frequency Threshold: 0
Time Frame: Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).
Study: NCT04248933
Study Brief: Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Peer-Delivered Behavioral Activation ("Peer Activate") Participants received a peer recovery specialist-delivered behavioral activation (BA) intervention ("Peer Activate") to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention. The Peer Activate intervention consisted of weekly one-hour BA sessions led by a peer recovery specialist (PRS) for up to 12 weekly sessions, with the first five being the core treatment sessions and content, and the subsequent seven designed to reinforce core content. In these sessions, participants received individualized support in learning skills to assist in their retention and persistence in methadone treatment and were guided through exercises aimed at incorporating substance-free, rewarding activities into their daily life. 0 None 11 37 5 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Medical event NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Medical event NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Medical event NON_SYSTEMATIC_ASSESSMENT General disorders None View