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 @ 12:26 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
NCT ID: NCT02006758
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected over 12 months.
Study: NCT02006758
Study Brief: Observational Study of the EnligHTN Renal Denervation System in Europe
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Uncontrolled Hypertension Participants Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension 1 None 8 68 5 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Myocardial Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Renal Artery Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sustained Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Viral Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
VASC Vessel Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Arterial Hypertension/Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Bacterial Infections of the Skin SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Drug Side Effect SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Urinary Tract Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View