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 @ 9:33 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT03724032
Description: Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.
Frequency Threshold: 0
Time Frame: During the 2-weeks of HD-tDCS treatment
Study: NCT03724032
Study Brief: Investigation and Modulation of the Mu-opioid Mechanisms in TMD (in Vivo)
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 TMD Patients TMD patients who received active HD-tDCS treatment for 10 days 0 None 0 4 4 4 View
Sham TMD Patients TMD patients who complete 10 sham treatments 0 None 0 4 4 4 View
Healthy Volunteers Healthy Volunteers did not receive treatment. 0 None 0 15 0 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Investigations None View
Scalp Pain SYSTEMATIC_ASSESSMENT Investigations None View
Scalp Burn sensation (mild) SYSTEMATIC_ASSESSMENT Investigations None View
Tingling SYSTEMATIC_ASSESSMENT Investigations None View
sleepiness SYSTEMATIC_ASSESSMENT Investigations None View