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: NCT04992494
Description: Adverse events were systematically assessed using weekly questionnaires during the study intervention. Serious adverse events and all-cause mortality were not monitored/assessed.
Frequency Threshold: 0
Time Frame: 16 weeks
Study: NCT04992494
Study Brief: Treatment for Migraine and Mood (Team-M)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) Mindfulness-based cognitive therapy delivered by Telephone MBCT-Telephone: Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via telephone by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium. The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment. 0 None 0 0 7 8 View
MBCT-V (Mindfulness-Based Cognitive Therapy - Video) Mindfulness-based cognitive therapy delivered by Video MBCT-Video: Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via WebEx video-conferencing by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium. The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment. 0 None 0 0 4 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased severity of migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Flashback SYSTEMATIC_ASSESSMENT General disorders None View
COVID infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsening hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Worsening mood SYSTEMATIC_ASSESSMENT General disorders None View