Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:31 AM
Ignite Modification Date: 2025-12-26 @ 1:06 AM
NCT ID: NCT03632434
Description: In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
Frequency Threshold: 0
Time Frame: Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
Study: NCT03632434
Study Brief: Transcranial Direct Current Stimulation Therapy for Major 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
tDCS 6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes. transcranial direct current stimulation: tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from. 0 None 0 26 26 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Skin redness SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT General disorders None View
Tingling SYSTEMATIC_ASSESSMENT General disorders None View
Burning sensation SYSTEMATIC_ASSESSMENT General disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT General disorders None View
Trouble concentrating SYSTEMATIC_ASSESSMENT General disorders None View
Acute mood change SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tingling in face SYSTEMATIC_ASSESSMENT General disorders None View
Blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Altered breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Flash of light in vision SYSTEMATIC_ASSESSMENT Eye disorders None View