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 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT03437512
Description: None
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT03437512
Study Brief: Non-invasive Brain Stimulation in Adults Who Stutter
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 and Fluency Training Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days). Anodal tDCS: 20 minutes of 2mA anodal stimulation. Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes 0 None 0 12 12 12 View
Sham tDCS and Fluency Training Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days). Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds. 0 None 0 11 10 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tingling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Warm sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT General disorders None View
Trouble concentrating SYSTEMATIC_ASSESSMENT General disorders None View
Acute mood change SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nervousness SYSTEMATIC_ASSESSMENT General disorders None View
Changes in visual sensations SYSTEMATIC_ASSESSMENT General disorders None View