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 @ 4:30 PM
Ignite Modification Date: 2025-12-25 @ 2:23 PM
NCT ID: NCT05445466
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected up to 3 months after tES treatment (10 sessions over 1 week) was completed.
Study: NCT05445466
Study Brief: Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical 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
Active HD-tDCS tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions). High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment 0 None 0 5 1 5 View
Active Control (Alpha, 10 Hz) Passive sham control; Two, twenty-minute sessions of passive sham control to the OFC for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions). High-Definition Transcranial Alternate-Current Stimulation: Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment 0 None 0 4 0 4 View
Personalized Beta-Gamma tACS tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions). High-Definition Personalized Beta-Gamma Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment 0 None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye Fatigue/Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View