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 @ 12:12 AM
Ignite Modification Date: 2025-12-25 @ 10:13 PM
NCT ID: NCT03799458
Description: None
Frequency Threshold: 0
Time Frame: adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
Study: NCT03799458
Study Brief: High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury
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 Stimulation Active HD-tDCS will be delivered while subjects perform sensory training tasks. Active High-definition transcranial direct current stimulation (HD-tDCS): Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates. 0 None 0 21 3 21 View
Imaging Only 40 subjects will undergo initial testing only as a healthy control group. 0 None 0 37 0 37 View
Sham Stimulation Sham HD-tDCS will be delivered while subjects perform sensory training tasks. Sham High-definition transcranial direct current stimulation (HD-tDCS): Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates 0 None 0 21 2 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nightmares NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View