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 @ 3:48 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT05772702
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
Study: NCT05772702
Study Brief: Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Closed-loop tACS Closed-loop individual alpha tACS daily for five consecutive days. 0 None 0 26 21 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp/neck pain SYSTEMATIC_ASSESSMENT General disorders None View
Muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View