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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT01372605
Description: Adverse events were collected without classification by specific Adverse Event Terms. Per protocol, hospitalizations were considered other adverse events in this study.
Frequency Threshold: 1
Time Frame: None
Study: NCT01372605
Study Brief: Trial of Collaborative Depression Care Management for HIV Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Collaborative Depression Care Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications None None 1 149 37 149 View
Enhanced Usual Care Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic. None None 2 155 37 155 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Medical hospitalization SYSTEMATIC_ASSESSMENT Immune system disorders None View
Psychiatric hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View