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 @ 3:08 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT02746705
Description: side effect by active and sham participants, with number of participants occurring and total number of occurrences across sessions.
Frequency Threshold: 0
Time Frame: 4 Weeks
Study: NCT02746705
Study Brief: Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation (tDCS): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models Cognitive Training Program 0 None 0 17 15 17 View
Sham Transcranial Direct Current Stimulation (tDCS) Sham Transcranial Direct Current Stimulation: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Cognitive Training Program 0 None 0 14 12 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tingling at electrode site NON_SYSTEMATIC_ASSESSMENT General disorders None View
Itching at electrode site NON_SYSTEMATIC_ASSESSMENT General disorders None View
headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Facial muscle twitching NON_SYSTEMATIC_ASSESSMENT General disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT General disorders None View
Localized head pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Forgetfulness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty concentrating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heat sensation at electrode site NON_SYSTEMATIC_ASSESSMENT General disorders None View