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 @ 10:02 PM
Ignite Modification Date: 2025-12-25 @ 7:39 PM
NCT ID: NCT05560932
Description: None
Frequency Threshold: 0
Time Frame: 2 months
Study: NCT05560932
Study Brief: HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIV Medications and Alcohol Use Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol IMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care). 0 None 0 38 1 38 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General disorders and administration site conditions - Other, specify NON_SYSTEMATIC_ASSESSMENT General disorders None View