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 @ 5:47 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT00721968
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00721968
Study Brief: Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1 Treatment Group: iStent + Cataract Surgery Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery None None 0 27 15 27 View
2 Control Group: Cataract Surgery Only Control Group (Group 2): Cataract surgery only None None 0 17 12 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
IOP increase >=10 mmHg versus baseline IOP at any visit None Eye disorders Adverse Event Term View
Posterior Capsule Opacification None Eye disorders Adverse Event Term View
Conjunctivitis None Eye disorders Adverse Event Term View
Iritis None Eye disorders Adverse Event Term View
Punctate Corneal Staining None Eye disorders Adverse Event Term View
BCVA Loss greater than or equal to 1 line after 3 months post-op None Eye disorders Adverse event term View
Eye pain None Eye disorders Adverse Event Term View
Blurry Vision None Eye disorders Adverse Event Term View
Retinal Detachment None Eye disorders Adverse Event Term View
Superficial Punctate Keratitis None Eye disorders Adverse Event Term View
Corneal Abrasion None Eye disorders Adverse Event Term View