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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT03372434
Description: All Serious Adverse Events (device related and non-device related) are reported. Device related non-serious adverse events are reported as Other Adverse Events.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03372434
Study Brief: Clinical Investigation of the Next-Generation Intraocular Lenses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Model ZYR00 Investigational IOL Device 0 None 4 74 3 74 View
Model ZFR00 Investigational IOL device 0 None 5 78 6 78 View
Model ZLB00 Control IOL Device 0 None 13 73 1 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cystoid Macular Edema NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular Hole SYSTEMATIC_ASSESSMENT Eye disorders None View
Bothersome Visual Symptom NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Herpes Zoster Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual symptoms requiring secondary surgical intervention NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Haptic anterior to capsule bag NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Increase in cells likely due to non-compliance with ocular medication regimen NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Hole SYSTEMATIC_ASSESSMENT Eye disorders None View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Patent Foramen Ovale SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angioplasty NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
B-cell Lymphoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Shingles NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Undisclosed illness requiring Hospice care NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bothersome visual symptom NON_SYSTEMATIC_ASSESSMENT Product Issues None View