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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT03372460
Description: Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
Frequency Threshold: 0
Time Frame: Up to three months
Study: NCT03372460
Study Brief: tDCS Plus Virtual Reality for PTSD
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 stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context. 0 None 2 26 18 26 View
Sham Stimulation Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context. 0 None 2 28 18 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exacerbation of chronic gastrointestinal illness NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Syncopal episode NON_SYSTEMATIC_ASSESSMENT General disorders None View
Treatment-emergent suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neck pain SYSTEMATIC_ASSESSMENT General disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT General disorders None View
Tingling SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ringing or buzzing in ears SYSTEMATIC_ASSESSMENT General disorders None View
Sleepy, drowsy, or fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Head pain SYSTEMATIC_ASSESSMENT General disorders None View
Burning SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Change in mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Changes in concentration SYSTEMATIC_ASSESSMENT General disorders None View
Flickering lights SYSTEMATIC_ASSESSMENT General disorders None View
Blurry vision SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness or lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View