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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT03084367
Description: As noted above, the only reportable events were Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects. Subjects were followed for 12 months, with follow-up visits at 1, 6, and 12 months.
Frequency Threshold: 0
Time Frame: Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects were collected and if any occurred, they would likely occur during the procedure when the device is being used. Subjects were followed for 12 months and all complaints promptly reported.
Study: NCT03084367
Study Brief: Physiologic Assessment of Coronary Stenosis Following PCI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results. 0 None 12 467 0 467 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Target Vessel Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ischemia-driven Target Vessel Revascularization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Recurrent Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):