Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT02039856
Description: Patients were not directly involved in this research other than to participate in a survey.
Frequency Threshold: 0
Time Frame: No adverse events were expected for EBQI-supported WH-PACT implementation (target of action is VA employees). However, we did collect data from women Veteran routine primary care patients. Eligible patients were considered low-risk, so a formal suicidality assessment was not included. However, in an abundance of caution, any survey respondent who endorsed feeling down, depressed or hopeless at baseline, 12-months or 24-months received information about VA's suicide hotline.
Study: NCT02039856
Study Brief: Implementation of Women's Health Patient Aligned Care Teams
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EBQI-Supported WH-PACT Implementation Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance. 5 None 0 2720 0 2720 View
Routine WH-PACT Implementation National policy guidance including VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities. 3 None 0 1180 0 1180 View
Serious Events(If Any):
Other Events(If Any):