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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:38 AM
NCT ID: NCT02289560
Description: Intraprocedural, at ea. follow-up visit (1 Month, 3 Month, 6 Month, 12 Month and annually through Year 5
Frequency Threshold: 0
Time Frame: Intraprocedural cumulative through 5 Years
Study: NCT02289560
Study Brief: Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transcranial Exablate Transcranial Exablate Transcranial Exablate: Transcranial Exablate 3 None 2 61 52 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Myocardial Infarction. SYSTEMATIC_ASSESSMENT Cardiac disorders Custom View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lethargy SYSTEMATIC_ASSESSMENT General disorders Custom View
Imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Jaw pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom View
Dysgnathia SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom View
Imbalance SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Gait disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Slurred speech SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Custom View
IV site infection SYSTEMATIC_ASSESSMENT Infections and infestations Custom View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Numbness/Tingling SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom View
Headache SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom View
Edema SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom View
Imabalance SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Custom View
Vision problem SYSTEMATIC_ASSESSMENT Eye disorders Custom View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Hemi-body muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Musculoskeletal weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Myoclonus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysmetria SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Numbness/Tingling SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Unclear thinking SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View