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 @ 12:46 PM
Ignite Modification Date: 2025-12-25 @ 12:14 PM
NCT ID: NCT03906461
Description: Per protocol, only device or procedure-related serious adverse events were collected and reported. While defined in the protocol, non-serious and non-related adverse event data was not collected in this study. Determination of whether there was a reasonable possibility that an investigational product or device under investigation caused or contributed to an SAE was determined by the investigator.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT03906461
Study Brief: LSI (Lesion Index) Workflow Observational 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
TactiCath SE and LSI Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module. US only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark 1 None 1 143 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Perforation or Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):