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 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:16 PM
NCT ID: NCT03361293
Description: None
Frequency Threshold: 0
Time Frame: 56 days
Study: NCT03361293
Study Brief: Cognitive Training and tDCS for Children With FASD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cognitive Training and Sham tDCS 5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode) 0 None 0 19 19 19 View
Cognitive Training and Active tDCS 5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training 0 None 0 19 19 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Scalp discomfort SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tingling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Unusual feelings, attitudes, emotions SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Itchiness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty paying attention SYSTEMATIC_ASSESSMENT General disorders None View
Tooth pain SYSTEMATIC_ASSESSMENT General disorders None View
Change in hearing SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Twitching / muscle movement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Forgetfullness SYSTEMATIC_ASSESSMENT General disorders None View
Balance problem SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Change in dominant hand function SYSTEMATIC_ASSESSMENT Nervous system disorders None View