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 @ 12:32 PM
Ignite Modification Date: 2025-12-25 @ 12:10 PM
NCT ID: NCT01608061
Description: An independent Clinical Events Committee (CEC) reviewed all reported adverse events. The CEC was responsible for conducting a review of all adverse events reported for study subjects. The CEC will adjudicate and classify all events for relatedness to the study system, study procedure and study requirements. The CEC will determine if any serious device-related adverse event is an unanticipated adverse device effect (UADE).
Frequency Threshold: 5
Time Frame: Adverse events were collected from the time of consent until study exit for each subject. Maximum duration was 48 months.
Study: NCT01608061
Study Brief: ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DBS-f Off DBS-f off DBS-f off: deep brain stimulation of the fornix turned off 0 None 8 21 17 21 View
DBS-f on DBS-f on DBS-f on: deep brain stimulation of the fornix 1 None 8 21 19 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Increased rigidity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
myocardial infarction with stent SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Device infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abnormal MRI SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Subdural hematoma SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Lead misplacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Change in Mental Status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Contact Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Delerium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fecal Incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT General disorders None View
Migraine SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Paranoid Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Incontenance SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
visual Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View