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 @ 10:57 PM
Ignite Modification Date: 2025-12-25 @ 8:25 PM
NCT ID: NCT02224469
Description: None
Frequency Threshold: 0
Time Frame: 8.5 years
Study: NCT02224469
Study Brief: First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ECoG (electrocorticography) sensing Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology 2 None 5 6 5 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
disease related respiratory failure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
low oxygen NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Numbness in ear cup NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased medical fitness NON_SYSTEMATIC_ASSESSMENT General disorders None View
High blood pressure, high heart rate and fever NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension, anemia and thrombocytopenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
High inflammatory values NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hearing loss NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
pain in the neck NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Occasional jaw lock NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bladder infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lower well being NON_SYSTEMATIC_ASSESSMENT General disorders None View