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 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:26 AM
NCT ID: NCT01370733
Description: Primarily systematic assessments, some reporting was unsolicited although minimal.
Frequency Threshold: 2
Time Frame: All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination.
Study: NCT01370733
Study Brief: Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active sTMS Treatment with the NEST-1 Device NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder. None None 2 103 80 103 View
Sham Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered. None None 1 99 42 99 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization (Suicide Attempt) SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Hospitalization (Risk of Self Harm) SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Hospitalization (Dehydration) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (Unspecified) View
Visual Disturbance SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (Unspecified) View
Dyschezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Non-Specific GI Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Hand/Arm/Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Leg and Foot Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Agitation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Lack of Energy SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View