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 @ 4:13 AM
Ignite Modification Date: 2025-12-26 @ 3:12 AM
NCT ID: NCT02243020
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02243020
Study Brief: VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vagus Nerve Stimulation (VNS) + Rehabilitation (1) This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. Vagus Nerve Stimulation (VNS) None None 0 8 4 8 View
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation. Vagus Nerve Stimulation (VNS) None None 3 9 4 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shortness of Breath and Dysphagia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain/Bruising from implant surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View