Adverse Events Module

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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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT04485858
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT04485858
Study Brief: First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CorNeat KPro Intraocular implantation of the CorNeat KPro CorNeat KPro: CorNeat KPro will be implanted into the subject's eye where the optic component snaps into the patient's trephined cornea and is sutured to the eye wall using 3 non-degradable sutures and the skirt component is placed under the conjunctiva 0 None 7 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exposure of implant NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Flat AC with bleeding NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fungal infection in the skirt of artificial cornea NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shallow retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dehiscence of prosthesis superiorly NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowth NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Choroidal detachment and exudative detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Covid 19 Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retro prosthetic membrane NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Exposed synthetic skirt of the implant NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
White nodule on the prosthetic skirt NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
left eye ocular pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
fungal infection in the skirt of cornet artificial cornea NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
abnormal serum enzyme levels NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
elevated IOP NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
watery eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Severe headache (crown top right) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Light sensitivity NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
nausea, body rash NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain around eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Choroidal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous Hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Shallow retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hyphema NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Patient had vitrectomy, with PRP laser and Avastin injections done on July 28th due to the non-resol NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dehiscence of prosthesis superiorly due to retraction NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowth NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
During sep. of iris from cornea bleeding began & didnt allow surgeon to place device in good conditi NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival retraction NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Disjunction of the nasal part of the KPRO NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Choroidal detachment and exudative detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View