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 @ 7:49 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT00367003
Description: None
Frequency Threshold: 0
Time Frame: Data for Adverse Events and Severe Adverse Events was collected during follow up time of the Primary Outcome (up to 24 weeks post intervention).
Study: NCT00367003
Study Brief: Deep Brain Stimulation for Treatment Resistant Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Deep Brain Stimulation Participants with treatment resistant depression will have a device implanted for deep brain stimulation. Deep Brain Stimulation: The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary. 0 None 6 28 14 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT General disorders None View
Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cap Erosion with dehissence of suture line SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Axiety requiring hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
DBS system revision as a result of dislodgement SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Car accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View