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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT02772302
Description: Participants with Disorders of Consciousness or Locked in Syndrome were enrolled in the Neuro-ICU where adverse events, related or unrelated to the intervention/device were systematically monitored through regular investigator assessment and regular laboratory testing.
Frequency Threshold: 0
Time Frame: During mindBEAGLE assessment in the intensive care unit, which lasted up to 4 hours.
Study: NCT02772302
Study Brief: Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
mindBEAGLE Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface 0 None 1 10 0 10 View
Healthy Controls healthy subjects with no history of neurological disease 0 None 0 10 0 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):