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 @ 4:17 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT02252666
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02252666
Study Brief: Exploring the Use of Non-invasive Neuromodulation Combined With Exercise in People With Advanced Multiple Sclerosis (MS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neuromodulation Rehabilitation Balance, posture and gait activities; therapeutic exercise for isolated muscle control; transfer training; and relaxation training using neurostimulation modulation. 2-week in lab intervention training, training at home and periodic return for follow-up testing and instruction on the next phase of the intervention. Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII. 0 None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Trigeminal Neuralgia (TN) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Osteoarthritis Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View