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 @ 4:14 PM
Ignite Modification Date: 2025-12-25 @ 2:12 PM
NCT ID: NCT01496066
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT01496066
Study Brief: Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
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 Randomized to have the Light Adjustable Lens implanted 1 None 42 403 292 403 View
Monofocal Control IOL Randomized to have the Monofocal control IOL implanted 4 None 10 197 125 197 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Herpetic Keratouveitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Persistent Induced Tritan Color Anomaly SYSTEMATIC_ASSESSMENT Eye disorders None View
Cystoid Macular Edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Endophthalmitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Horseshoe retinal tear with vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypopyon SYSTEMATIC_ASSESSMENT Eye disorders None View
Surgical complication SYSTEMATIC_ASSESSMENT Eye disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blood clots due to lymphoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Broken blood vessel in brain SYSTEMATIC_ASSESSMENT Vascular disorders None View
Broken wrist SYSTEMATIC_ASSESSMENT General disorders None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain with pacemaker SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart surgery SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization due to cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to concussion with subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization due to emphysema/COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization due to infection after knee surgery SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to syncope SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization for colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization due to low blood pressure and syncope SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Liver cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant neuroendocrine tumors SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Vascular disorders None View
Triple bypass surgery SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Secondary surgical intervention SYSTEMATIC_ASSESSMENT Eye disorders None View
Phytotoxic retinal damage causing temporary loss of BSCVA SYSTEMATIC_ASSESSMENT Eye disorders None View
Persistent induced erythropsia SYSTEMATIC_ASSESSMENT Eye disorders None View
Persistent unanticipated increase refractive error SYSTEMATIC_ASSESSMENT Eye disorders None View
Intraoperative capsular tear SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anterior chamber cells SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber flare SYSTEMATIC_ASSESSMENT Eye disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal edema central SYSTEMATIC_ASSESSMENT Eye disorders None View
corneal edema wound SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior capsular opacity SYSTEMATIC_ASSESSMENT Eye disorders None View
Raised IOP not requiring treatment SYSTEMATIC_ASSESSMENT Eye disorders None View
Raised IOP requiring treatment SYSTEMATIC_ASSESSMENT Eye disorders None View
Superficial punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View