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 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:50 PM
NCT ID: NCT05183867
Description: None
Frequency Threshold: 0
Time Frame: data collected up to 4 months on study
Study: NCT05183867
Study Brief: Behavior, Biology and Well-Being Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Minds Program (HMP) App Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. 0 None 0 462 78 462 View
Psychoeducation App Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. 0 None 0 463 64 463 View
Usual Care Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. 0 None 0 232 44 232 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased Symptoms of Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View