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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT00583804
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00583804
Study Brief: Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord 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
Implanted Individuals Individuals implanted with stimulator/sensor device. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. Note that all subjects received the implanted device and used the device in the laboratory and at home throughout the course of the study. Therefore there is only a single Arm for adverse events - all subjects received the intervention and stimulation. None None 0 10 2 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Device infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View