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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:50 PM
NCT ID: NCT02881151
Description: Adverse events are presented in a single group because the study was designed to assess any adverse events during the study as a whole, not whether adverse events were associated with any particular study phase.
Frequency Threshold: 0
Time Frame: 1 year (treatment phase plus continuation phase)
Study: NCT02881151
Study Brief: Deep Brain Stimulation for the Treatment of Traumatic Brain 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
Treatment Subjects will be treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that will be undertaken to assess for any possible therapeutic effect. Deep brain stimulation: Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. 0 None 2 6 4 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection of DBS device SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Wound site bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower extremity pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cognitive difficulty SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unintended stimulator deactivation SYSTEMATIC_ASSESSMENT Product Issues None View
Gait disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View