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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT04031404
Description: None
Frequency Threshold: 0
Time Frame: Up to 2 months per participant
Study: NCT04031404
Study Brief: Glucose and Non-Invasive Brain 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-EEG After Glucose Drink Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (\~300 mL). During every session, participants receive single pulse TMS to the motor cortex, and complete EEG recordings and a working memory task at several time points. 0 None 0 11 10 11 View
TMS-EEG After Placebo Drink Participants receive TMS to motor cortex following consumption of a water control drink (\~300 mL). During every session, participants receive single pulse TMS to the motor cortex, and complete EEG recordings and a working memory task at several time points. 0 None 0 10 8 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

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