Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT01772693
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01772693
Study Brief: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson'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
ExAblate Transcranial MRgFUS ExAblate Transcranial MR guided Focused Ultrasound ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound 0 None 3 20 20 20 View
Sham ExAblate Transcranial MRgFUS Sham treatment with ExAblate MR guided Focused Ultrasound Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound 0 None 1 7 5 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Degenerative knee disease NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cerebelar infarct NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sleep Disorder NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dysgnosia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor worsened NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatique NON_SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysgnosia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dysmetria NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Thalamotomy related View
Imbalance NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysmetria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Numbness/tingling NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unsteady NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sonication related flushing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Visual field defect NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea/Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Imbalance NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Positional pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Imbalance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysgnosia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Numbness/tingling NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sonication related scalp pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sonication related head pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pin Site Pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pigment change in eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision change NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vocal change NON_SYSTEMATIC_ASSESSMENT General disorders None View
Worsening depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Musculoskeletal weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Positional pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Transient Ischemic Attack NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Facial edema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pin site numbness/tingling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pin site pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stereotactic frame bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View