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: 2025-12-24 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:11 PM
NCT ID: NCT04236856
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT04236856
Study Brief: CorPath® GRX Neuro Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Robotic Endovascular Procedure Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System. Robotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System. 1 None 40 117 21 117 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vascular Access Site Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion Episode SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Digestive Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Extremity Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fibula Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flow Diverter Endovascular Procedure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intraprocedural Aneurysm Rupture SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Perforated Sigmoid Diverticulitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Relapsed Leukemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Revascularization SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Right radial pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vascular Site Access Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Electrolyte Disorder SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Confusion Episode SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensory Deficit SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Galactorrhea SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hemianopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Urine Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vasospasm SYSTEMATIC_ASSESSMENT Vascular disorders None View