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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:07 AM
NCT ID: NCT03828734
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were systematically assessed after the 3 hour session for both arms. Each session was 1 week apart. Thus, adverse events were monitored for approximately 1 week.
Study: NCT03828734
Study Brief: Modulation of Cognitive Control Signals in Prefrontal Cortex by Rhythmic Transcranial Magnetic Stimulation
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 to Frontal Cortex Participants receive TMS to frontal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS. 0 None 0 53 25 53 View
TMS to Parietal Cortex Participants receive TMS to parietal cortex while performing a cognitive control task. During every session, participants receive Theta TMS, Alpha TMS, and Arrhythmic TMS. 0 None 0 50 25 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tingling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ringing or buzzing noise SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT General disorders None View
Trouble concentrating SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Flickering lights SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View