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: 2025-12-24 @ 7:21 PM
Ignite Modification Date: 2025-12-25 @ 5:00 PM
NCT ID: NCT04081103
Description: None
Frequency Threshold: 0
Time Frame: 2 months
Study: NCT04081103
Study Brief: NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nexagon® (Lufepirsen) High Dose Concentration Nexagon® (lufepirsen) High Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. 0 None 0 12 7 12 View
Nexagon® (Lufepirsen) Low Dose Concentration Nexagon® (lufepirsen) Low Dose Concentration: Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. 0 None 1 12 8 12 View
Vehicle Vehicle: Vehicle is administered topically in the affected eye three (3) times over 28 days. Open-label Nexagon® (lufepirsen): Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. 0 None 0 11 7 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cicatricial ectropion with lateral lagophthalmos and exposed lacrimal gland SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Symblepharon SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Corneal epithelium defect SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Corneal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Corneal thinning SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Ectropion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Hyperplasia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Hypopyon SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Periorbital cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Eyelid scar SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View