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 @ 10:37 PM
Ignite Modification Date: 2025-12-25 @ 8:09 PM
NCT ID: NCT00142935
Description: Fatal Overdoses
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT00142935
Study Brief: Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
As Assigned: Pre-release MMT + Referral Post Release + Payment Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews. None None 0 29 10 26 View
As Assigned: MMT Referral Post Release + Payment Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews. None None 2 28 8 20 View
As Assigned: MMT Referral Post Release Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance. Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews. None None 1 30 8 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatal Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospitalizations SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non-fatal Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ER visits SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View