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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT03258632
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected from the time of study entry until the end of planned study participation which was 12 months.
Study: NCT03258632
Study Brief: Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified. 5 None 19 82 0 82 View
Intervention Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach. Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST): Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach. 3 None 10 73 0 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):