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 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:03 AM
NCT ID: NCT04241094
Description: This is a minimal risk study with very few participants. The likelihood of a serious adverse event or death is not likely.
Frequency Threshold: 0
Time Frame: The investigators collected adverse event data for all participants (Veterans and loved ones) from the date of enrollment through date of 3 month follow-up assessment. This included reviewing the medical chart for all veteran participants. For loved ones, the investigators would include adverse events that were explicitly stated by loved ones to study staff (none of these occurred).
Study: NCT04241094
Study Brief: Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Loved One Assisted Treatment The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2. Loved one assisted treatment: The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2. 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):