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 @ 1:28 AM
Ignite Modification Date: 2025-12-25 @ 11:40 PM
NCT ID: NCT04308694
Description: None
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT04308694
Study Brief: Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance 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
Pharmacy-based Methadone Treatment Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program. Pharmacy-based methadone administration and dispensing: Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy. 0 None 1 20 0 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-study related hospitalization for abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):