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 @ 9:17 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT03412604
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT03412604
Study Brief: Effect of Modulating Gamma Oscillations Using tACS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
tACS Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 20 sessions on consecutive weekdays. The tACS intervention (20 sessions) will be preceded and followed by amyloid, microglia and tau PET imaging as well as a clinical/cognitive evaluation. The assessment of the effect of stimulation on microglia activation, amyloid deposition and tau deposition will constitute a primary outcome measure. Assessment of adverse effects will be also evaluated as a secondary outcome. The effect of brain stimulation on brain connectivity will be assessed by EEG and MRI and cognitive function. Transcranial Alternating Current Stimulation (tACS): tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region. 0 None 1 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sensation Under Electrodes SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Scalp Pain SYSTEMATIC_ASSESSMENT General disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT General disorders None View
Skin Irritation SYSTEMATIC_ASSESSMENT General disorders None View
Sensations Under Electrodes SYSTEMATIC_ASSESSMENT General disorders None View
Visual Changes SYSTEMATIC_ASSESSMENT General disorders None View
Mood Change SYSTEMATIC_ASSESSMENT General disorders None View