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 @ 10:07 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT01749735
Description: None
Frequency Threshold: 0
Time Frame: No adverse events were observed
Study: NCT01749735
Study Brief: Transcranial Direct Current Stimulation (tDCS) and Motor Training for Traumatic Brain Injury (TBI) Survivors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Armeo Training With Continuous tDCS Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks. Armeo training: Upper extremity training with the use of a weight support device and virtual reality. None None 0 2 1 2 View
Armeo Training With Sham tDCS Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks. Armeo training: Upper extremity training with the use of a weight support device and virtual reality. None None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arm Pain SYSTEMATIC_ASSESSMENT General disorders None View