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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:39 PM
NCT ID: NCT03874351
Description: None
Frequency Threshold: 0
Time Frame: Three months (through the two-month neurostimulation period plus 30 days after the last stimulation).
Study: NCT03874351
Study Brief: A Study of Home-Delivered Neurostimulation for Migraine
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 tDCS The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA). non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. 0 None 0 11 1 11 View
Sham tDCS Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time. non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. 0 None 0 11 1 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View