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 @ 4:45 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT03275350
Description: None
Frequency Threshold: 3
Time Frame: 24 weeks
Study: NCT03275350
Study Brief: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Extended-release Naltrexone (XR-NTX) Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone 2 None 5 55 11 55 View
Treatment as Usual (TAU) Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic 1 None 7 59 7 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory disorders NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neoplasms benign, malignant and unspecified NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Psychiatric disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Injury, poisoning and procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular disorders NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory disorders NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Psychiatric disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nervous system disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View