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 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT04136366
Description: None
Frequency Threshold: 5
Time Frame: The safety assessment period was up to twenty-four weeks.
Study: NCT04136366
Study Brief: The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ADX-2191 ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks 0 None 0 68 39 68 View
Standard Surgical Care Standard surgical care performed 0 None 1 38 24 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Cystoid macular oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract subcapsular SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular fibrosis SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber inflammation SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular Oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal epithelium defect SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber cell SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypotony of eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Iris adhesions SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber fibrin SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior capsule opacification SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Foreign body in eye SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyphaema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural inflammation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View