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 @ 5:30 PM
Ignite Modification Date: 2025-12-24 @ 5:30 PM
NCT ID: NCT03952468
Description: Adverse events as defined in our study were identical to clinicaltrials.gov definitions. Adverse events were collected in several ways: 1) events spontaneously reported by participants, 2) review of medical records preceding each follow up period, 3) systematically assessed through a side effects questionnaire that was administered before and after each TMS or sham TMS session, and 4) systematically assessed through the Treatment History Questionnaire.
Frequency Threshold: 5
Time Frame: Up to one year.
Study: NCT03952468
Study Brief: Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TMS + Brief Cognitive Behavioral Therapy Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Transcranial Magnetic Stimulation: Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex. Brief Cognitive Behavioral Therapy: BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems. 0 None 6 18 11 18 View
Sham TMS + Brief Cognitive Behavioral Therapy Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide Sham Transcranial Magnetic Stimulation Brief Cognitive Behavioral Therapy: BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems. 1 None 5 15 6 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychiatric rehospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medical hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Psychiatric hospitalization due to worsening mental health symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medical hospitalization SYSTEMATIC_ASSESSMENT Vascular disorders None View
Medical hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
ER visit for psychiatric reasons SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headaches SYSTEMATIC_ASSESSMENT General disorders None View
Treatment site discomfort SYSTEMATIC_ASSESSMENT General disorders None View