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 @ 1:41 AM
Ignite Modification Date: 2025-12-25 @ 11:57 PM
NCT ID: NCT02158494
Description: * Category - the medical terminology for the adverse event or unanticipated problem category from the Safety Profiler list of Common Terminology Criteria for Adverse Events (http://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx) * AE Detail - a detailed description of the severity of the category from the Safety Profiler list of Common Terminology Criteria for Adverse Events (http://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx)
Frequency Threshold: 5
Time Frame: 26 weeks
Study: NCT02158494
Study Brief: Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neurostimulation Balance and gait training using neurostimulation modulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Balance and Gait Training using neurostimulation modulation.: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII. 0 None 3 22 11 22 View
Minimally Perceivable Stimulation Balance and gait training using non-zero, minimally perceivable stimulation. 2-week in lab training (ITP), (2 in-lab training sessions and 1 home training session daily) followed by 12 weeks of training at home (HTP) (3 home training sessions daily), and a 12-week withdrawal period (no training). Balance and Gait Training using neurostimulation modulation.: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII. 0 None 1 21 8 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders None View
Gallbladder Obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Urinary Tract Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostate cancer SYSTEMATIC_ASSESSMENT Renal and urinary disorders Serious Adverse Even View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General Pain SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Kidney Stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diabetic Shock SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vomiting and Diahrrea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View