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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT00786032
Description: An adverse events (AE) can be any unfavorable or unintended sign, or symptom associated with the use of the device, including psychological signs or symptoms. Examples of adverse events may include one of the following:An effect of the investigational product and An accident or injury related to the device
Frequency Threshold: 2.1
Time Frame: Adverse events were collected from Screening until 3 months past the last follow-up visit. The period of collection 1 year and 10 months.
Study: NCT00786032
Study Brief: A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BCI Device All participants will use the BCI System as a means of communication. Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles. None None 12 27 6 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Medical device complication and disease progression. NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View
Fall or overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Gastrointestinal tube insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Respite care NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall or procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Therapy cessation and gastrointestinal tube insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Unevaluable event NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (12.0) View