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: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
NCT ID: NCT05202808
Description: Non-serious, ocular AEs are being reported for study eyes only.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT05202808
Study Brief: RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments 0 None 7 335 71 335 View
Control IOL Control IOL: Control treatment group will receive a Control IOL 0 None 2 165 26 165 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inpatient hospitalization following Hip Replacement Surgery SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Inpatient hospitalization for Ventral Hernia Repair Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Inpatient hospitalization due to Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Inpatient hospitalization due to Salmonella Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Inpatient hospitalization due to Obstruction of Gallbladder SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Secondary Surgical Intervention: Non-Study Eye, Macular Hole Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Secondary Surgical Intervention: Intraocular Lens Exchange SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Secondary Surgical Intervention: Iris Repositioning following prolapse SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Secondary Surgical Intervention: Study Eye, Selective Laser Trabeculoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Secondary Surgical Intervention: Non-Study Eye Intraocular Lens Exchange SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Non-Study Eye, Full Thickness Macular Hole SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Amaurosis Fugax SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior Chamber Inflammation SYSTEMATIC_ASSESSMENT Eye disorders None View
Blepharoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Blurry Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Clinically significant cystoid macular edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival Cyst SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Abrasion SYSTEMATIC_ASSESSMENT Eye disorders None View
Cystoid Macular Edema SYSTEMATIC_ASSESSMENT Eye disorders None View
De-centered optic SYSTEMATIC_ASSESSMENT Eye disorders None View
Dot Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Epithelial Defect SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypertensive Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders None View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratoconjunctivitis Sicca, not specified as Sjogrens SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Erosion SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivochalasis SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis Medicamentosa SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival Hyperemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual Symptoms due to Concussion SYSTEMATIC_ASSESSMENT Eye disorders None View
Dot Hemorrhages and Microaneurysms SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eye Syndrome SYSTEMATIC_ASSESSMENT Eye disorders None View
Epiretinal Membrane SYSTEMATIC_ASSESSMENT Eye disorders None View
Epithelial Basement Membrane Dystrophy SYSTEMATIC_ASSESSMENT Eye disorders None View
Erythropsia score 2 (red) any time after Week 3 or Erythropsia score 1 (pink) or 2 (red) at Month 6 SYSTEMATIC_ASSESSMENT Eye disorders None View
Floaters SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache SYSTEMATIC_ASSESSMENT Eye disorders None View
Hordeolum SYSTEMATIC_ASSESSMENT Eye disorders None View
Light Treatment Sensitivity SYSTEMATIC_ASSESSMENT Eye disorders None View
Loss of BCDVA of >= 10 letters (when compared to Preop and/or Postop Week 3 BCDVA) SYSTEMATIC_ASSESSMENT Eye disorders None View
Meibomian Gland Dysfunction SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular Allergies SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular Hypertension SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior Capsular tear SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior Vitreous Detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Raised IOP SYSTEMATIC_ASSESSMENT Eye disorders None View
Raised IOP >=10 mmHg above preop & >=25 mmHg (if present > Week 1), unrelated to mech. pupil. block SYSTEMATIC_ASSESSMENT Eye disorders None View
Rebound Iritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Hole SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Microaneurysm SYSTEMATIC_ASSESSMENT Eye disorders None View
Subconjunctival Abrasion with Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Superficial Punctate Keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Wound leak SYSTEMATIC_ASSESSMENT Eye disorders None View