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 @ 5:19 AM
Ignite Modification Date: 2025-12-26 @ 4:27 AM
NCT ID: NCT03452527
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
Study: NCT03452527
Study Brief: Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ICON-1 Maintenance Therapy ICON-1 maintenance therapy after initial aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection 0 None 2 7 6 7 View
ICON-1 Combination Therapy ICON-1 combination therapy with aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection 0 None 1 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transient Ischemic Attach (TIA) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Metabolic Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Macular Fibrosis SYSTEMATIC_ASSESSMENT Eye disorders None View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Subretinal Fluid SYSTEMATIC_ASSESSMENT Eye disorders None View
Choroidal Neovascularization SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Detachment of Retinal Pigment Epithelium SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Age Related Macular Degeneration SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelids Pruritus SYSTEMATIC_ASSESSMENT Eye disorders None View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular Oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Metamorphopsia SYSTEMATIC_ASSESSMENT Eye disorders None View
Optic Ischaemic Neuropathy SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Depigmentation SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Pigment Epithelial Tear SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual lmpairement SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous Detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Intraocular Pressure Increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal Reflux Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Drug Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital Herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View