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 @ 5:38 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT04498468
Description: None
Frequency Threshold: 0
Time Frame: Up to 42 days
Study: NCT04498468
Study Brief: Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Arm Treatment: Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA) Sustained Release Dexamethasone, 0.4 mg: dexamethasone 0.4mg lacrimal insert 0 None 1 77 19 77 View
Control Arm Control: FCIProlong® made of E-Caprolactone-L-Lactide copolymer (PCL) (FCI Ophthalmics Inc., Pembroke, MA) E-Caprolactone-L-Lactide copolymer (PCL) punctal plug: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment) 0 None 1 77 10 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Day 14 NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Week 6: Raised intraocular pressure (increase by 5-10 mm Hg from baseline) NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Week 6: Raised intraocular pressure (increase by >10 mm Hg from baseline) NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Week 6: Worsening of Corneal Fluorescein staining (increase by ≥2 from baseline) NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Week 6: Worsening of conjunctival lissamine green staining (increase by ≥2 from baseline) NON_SYSTEMATIC_ASSESSMENT Eye disorders None View