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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT03055832
Description: Any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. Chronic but stable conditions or diseases are not AEs. Changes in a chronic condition or disease consistent with natural disease progression are not AEs. AEs were assessed during procedure, immediately post-procedure, 1 day, 2 weeks, \& 4 weeks post-procedure.
Frequency Threshold: 5
Time Frame: 4 weeks
Study: NCT03055832
Study Brief: Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iLux 2020 System Meibomian Gland Treatment iLux 2020 System: Heating and compression to express clogged meibomian glands 0 None 0 71 5 71 View
LipiFlow Thermal Pulsation System Meibomian Gland Treatment LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands 0 None 0 71 4 71 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other SYSTEMATIC_ASSESSMENT Eye disorders None View