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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:57 PM
NCT ID: NCT03647267
Description: None
Frequency Threshold: 0.01
Time Frame: 24- weeks
Study: NCT03647267
Study Brief: Effects of Pneumatic Vitreolysis on Vitreomacular Traction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Observation Participants randomized to the observation group will receive a sham injection. Observation: No intervention; sham injection only 0 None 0 22 5 22 View
Pneumatic Vitreolysis Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas. Pneumatic Vitreolysis (C3F8 injection): Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina. 0 None 5 24 10 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Macular hole NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA View
Cataract traumatic (ocular injury) NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Endophthalmitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Retinal tear NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Rhegmatogenous retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Corneal edema NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Nuclear sclerosis NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Posterior vitreous detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Visual disturbances NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Vitreous hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Anterior chamber cell NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Anterior chamber flare NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Conjunctival hyperemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Corneal abrasion NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Epiretinal membrane NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Eye itching NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Macular hole NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Ocular hypertension NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Posterior capsule opacification NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Stye NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Subconjunctival hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Visual flashes NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View
Vitreous debris NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA View