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 @ 4:01 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT04333966
Description: The definitions of adverse and serious adverse events do not differ from the clinicaltrials.gov definition. In this table, parent and teens are combined such that numbers reflect the combined sample size for parents and teens overall. We did not split by parents and teens separately as no adverse events were reported for either group in either arm. Thus, we opted to report by arm and not split by group (parent and teen).
Frequency Threshold: 0
Time Frame: Adverse event data was collected over the life of study participation, which was 6 months.
Study: NCT04333966
Study Brief: Parental Research on Interventions for Social Media
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interactive PBI Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. Interactive Social Networking Site Parent Based Intervention: Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS. 0 None 0 100 0 100 View
Active Control Parents in the active control condition will receive an emailed copy of the Surgeon General's Call toAction: A Guide for Families. Active Control: Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families. 0 None 0 102 0 102 View
Serious Events(If Any):
Other Events(If Any):