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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:42 AM
NCT ID: NCT00640133
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected beginning after DBS device implantation and continued throughout each patient's participation in the study up to four years post-implantation and up to one year after exiting the protocol.
Study: NCT00640133
Study Brief: Effectiveness of Deep Brain Stimulation for Treating People With Treatment Resistant Obsessive-Compulsive Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active DBS Participants will receive deep brain stimulation. Active DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout. 0 None 3 15 10 15 View
Sham DBS Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter. Sham DBS: In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS. 0 None 1 12 7 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Symptom worsening SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Motor effect (fall) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Periorbital swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Symptom worsening SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypomania SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alcohol-related event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post-surgical discomfort/pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pocket stimulation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
GI discomfort/symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache/migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tiredness/severe fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View