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 @ 2:44 PM
Ignite Modification Date: 2025-12-25 @ 1:13 PM
NCT ID: NCT03805659
Description: Safety Population included all subjects who received at least one intervention.
Frequency Threshold: 0
Time Frame: Informed consent through study completion, approximately 28 weeks.
Study: NCT03805659
Study Brief: HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HD-tDCS Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). Adverse events reported in this group include relevant medical occurrences from the 10 sessions of HD-tDCS through post-intervention follow-up. HD-tDCS: High-Dose transcranial Direct Current Stimulation 0 None 1 4 2 4 View
Sham Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). Adverse events reported in this group include relevant medical occurrences from the 10 sessions of sham through post-intervention follow-up. Sham: Sham sessions (no electric current) 0 None 0 4 1 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding at electrode site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Erythema at collar bone post MEG SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headaches SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fall SYSTEMATIC_ASSESSMENT Social circumstances None View
Increased panic attacks SYSTEMATIC_ASSESSMENT Psychiatric disorders None View