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 @ 1:44 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT04035694
Description: Study risks were defined as discomfort with assessment procedures/content, or breach of confidentiality. Measures were taken to provide confidentiality with respect to questionnaire responses and program process data. To minimize the risk of discomfort for participants, participants could skip any question and quit participation at any time. Research staff scanned the incoming data on a regularly basis to record any concerns about any participants. No adverse events were reported.
Frequency Threshold: 0
Time Frame: Research staff members scanned the incoming online questionnaire data on a regularly basis and recorded any problems seen or concerns about any participants over the study timeframe (approx. 3 months).
Study: NCT04035694
Study Brief: Evaluation Study of the Online High School Media Aware Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Participants will receive access to Media Aware. Media Aware Sexual Health - High School: Media Aware is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages. 0 None 0 374 0 374 View
Delayed-Intervention Control Participants will receive their regular health education programming not related to sexual health education or media literacy education. 0 None 0 216 0 216 View
Serious Events(If Any):
Other Events(If Any):