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 @ 11:07 PM
Ignite Modification Date: 2025-12-25 @ 8:40 PM
NCT ID: NCT03789669
Description: Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level. 3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.
Frequency Threshold: 0.15
Time Frame: During the course of the study until termination (3 months)
Study: NCT03789669
Study Brief: A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Unilateral One eye treated with ELITA only, Fellow Eye Not Treated 0 None 0 3 3 3 View
Bilateral One eye treated with ELITA, fellow eye treated with iFS 0 None 0 197 2 197 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Miscreated Flap NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Epithelium in the interface with a loss of 2 or more lines of BSCVA (>10 ETDRS letters) NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View