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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT02890303
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
Study: NCT02890303
Study Brief: A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zepto Capsulotomy This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture \& Vitreous Loss (4% or less) Zepto System: Anterior Capsulotomy using the Zepto System. 0 None 0 100 5 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epithelial Erosion SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular Edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior Capsule Tear SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior Tear without Vitreous Loss SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Elevated IOP SYSTEMATIC_ASSESSMENT Eye disorders None View
Ache in Treatment Eye SYSTEMATIC_ASSESSMENT Eye disorders None View