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: 2025-12-26 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 11:46 AM
NCT ID: NCT02674516
Description: None
Frequency Threshold: 0
Time Frame: 48 hours after the end of the first stimulation session
Study: NCT02674516
Study Brief: The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anodal Stimulation Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period. Transcranial direct current stimulation 0 None 0 13 12 13 View
Sham Stimulation The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds. Sham transcranial direct current stimulation 0 None 0 11 8 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Itchiness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Burning SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mild warmth SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pinching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Iron taste SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View