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 @ 5:07 AM
Ignite Modification Date: 2025-12-26 @ 4:11 AM
NCT ID: NCT04939727
Description: None
Frequency Threshold: 0
Time Frame: Between enrollment (index date) and end of observation period (up to 12 months).
Study: NCT04939727
Study Brief: Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters. 0 None 23 46 3 46 View
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm) Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters. OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS 3 None 46 69 6 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Emergency Department Encounter SYSTEMATIC_ASSESSMENT General disorders None View
Inpatient stay SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Overdose SYSTEMATIC_ASSESSMENT General disorders None View