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 @ 7:15 PM
Ignite Modification Date: 2025-12-25 @ 4:51 PM
NCT ID: NCT00734903
Description: All serious adverse events reported were unrelated to the study and to the study treatments, as determined by our Institutional Review Board (IRB). Adverse events were monitored / reported only in terms of whether they were related or non-related to the study treatments, and not based on specific adverse event terms.
Frequency Threshold: 5
Time Frame: The full study period from each participant's randomization through 3-month followup.
Study: NCT00734903
Study Brief: Women Veterans' Substance Abuse Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A Woman's Path to Recovery (WPR) A gender-focused approach to addiction recovery None None 4 33 0 33 View
12-Step Facilitation (TSF) An evidence-based, non-gender-focused approach to addiction recovery None None 7 33 0 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
adverse events NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):