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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:38 PM
NCT ID: NCT01858194
Description: None
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT01858194
Study Brief: REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Renal Sympathetic Denervation Catheter-based Renal Sympathetic Denervation Ablation Arm Renal sympathetic denervation: • The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. • After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion). 0 None 3 9 5 9 View
VT Ablation Alone No further therapy in addition to VT ablation VT ablation alone: Placebo arm will receive standard VT ablation using current techniques 0 None 2 8 3 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Macrohematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
VT recurrence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-sustained VT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
AF with urosepsis SYSTEMATIC_ASSESSMENT General disorders None View
Worsening heart failure/Total artifical heart implant SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pseudoaneurysm at septal aspect of LV apex SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dissection of left external iliac artery SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
LUE Cephalic vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension with pleuritic chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Kidney pain with near syncope SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bradycardia associated with dyspnea on exertion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Jaw pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
VT recurrence SYSTEMATIC_ASSESSMENT Cardiac disorders None View