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 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:44 AM
NCT ID: NCT00407602
Description: Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.
Frequency Threshold: 0
Time Frame: 10 years
Study: NCT00407602
Study Brief: Argus® II Retinal Stimulation System Feasibility Protocol
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Single arm with fellow eye as comparator 1 None 13 30 28 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Conjunctival dehiscence SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival erosion NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal melt NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Endophthalmitis - infective NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Epiretinal membrane NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypotony NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Iris rubeosis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratitis - infective NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Migration (extra-ocular) of intraocular silicone oil NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Re-tack NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal detachment - rhegmatogenous NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal detachment - tractional and serous NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal tear NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
360 Circumferential Vitreous Band Traction NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Choroidal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Choroidal effusion NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival congestion NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival cyst NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival dehiscence NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival erosion NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis - inflammatory NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal abrasion NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal dryness NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal epithelial defect NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal fold NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal opacity NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Suture Broken NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal vascularization NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Decrease in light perception NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Elective revision surgery NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Epiphora NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Epiretinal membrane NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fibrosis around retinal tack NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Filamentary keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Foreign Body Sensation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
High IOP NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hyphema NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypotony NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Inflammation - ocular NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Irregular pupil NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratic Precipitates NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nystagmus increase NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular fibrin NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain - ocular NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Pre-retinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Proliferative Vitreoretinopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ptosis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Break/Tear NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal detachment - tractional NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal folds NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Thickening - cystoid macular edema (CME) NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Thickening - without cystic changes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinoschisis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Revision Surgery - tack replacement NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Rubeosis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Scleral graft displacement or reabsorption NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Scleritis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Suture irritation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vitreous hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View