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 @ 5:36 PM
Ignite Modification Date: 2025-12-25 @ 3:07 PM
NCT ID: NCT03539068
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of study entry until the end of study participation, at WEB-ED completion for baseline, at RCT inclusion, and at final interview (an average of 8 months)
Study: NCT03539068
Study Brief: Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
WEB-ED+ Treatment Arm Veterans who screen positive on one or more mental health screens in WEB-ED will be RCT-eligible. RCT-consenters randomly assigned to the WEB-ED+ Treatment are will receive:: * eHealth interfaces tailored to Veterans' VA and MHV enrollment needs (links for electronic VA enrollment, MHV and MHV premium status enrollment). * Shared decision making (SDM) interfaces: Patient Decision aids (PTSD, depression, alcohol abuse); SDM educational video; videos). * Access to study staff available through a toll-free number to assist both Veterans and providers, including addressing questions, problem-solving about or assisting with stuck points (e.g. getting screening results to the provider). 0 None 0 214 0 214 View
WEB-ED Only Control Arm Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the no intervention control group will receive no further intervention but asked to participate in a subsequent study phase that addresses VA and post-deployment care access 0 None 0 102 0 102 View
Serious Events(If Any):
Other Events(If Any):