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 @ 10:57 PM
Ignite Modification Date: 2025-12-25 @ 8:25 PM
NCT ID: NCT03861169
Description: None
Frequency Threshold: 0
Time Frame: 12 Months
Study: NCT03861169
Study Brief: Study of OMNI System in OAG (GEMINI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iTT/Safety The ITT/Safety population, defined as all enrolled and treated subjects regardless of whether or not they had a protocol deviation, comprised 149 subjects. All safety evaluations were performed on this population. 34 None 2 149 34 149 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Torn rotator cuff subsequent to fainting (Unrelated) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bradycardia (Unrelated) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Posterior capsular tear SYSTEMATIC_ASSESSMENT Eye disorders None View
Loss of 2 lines or more BCVA (10 or more ETDRS letters) at or after 3 months postoperative SYSTEMATIC_ASSESSMENT Eye disorders None View
Chronic anterior uveitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Layered hyphema greater than or equal to 1mm SYSTEMATIC_ASSESSMENT Eye disorders None View
Peripheral Anterior Synechiae >1 clock hour SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Clinically significant cystoid macular edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Increase in C/D ratio of > 0.3 units compared to baseline on slit lamp exam SYSTEMATIC_ASSESSMENT Eye disorders None View
IOP increase requiring management with systemic medication at greater than or equal to 1 month visit SYSTEMATIC_ASSESSMENT Eye disorders None View
IOP increase greater than or equal to 10 mmHg above baseline IOP at greater than or equal to 1M SYSTEMATIC_ASSESSMENT Eye disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Cystoid macular edema (CME) SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Guttae SYSTEMATIC_ASSESSMENT Eye disorders None View
Hordeolum SYSTEMATIC_ASSESSMENT Eye disorders None View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Microhyphema SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular migraine SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior capsular opacification (PCO) SYSTEMATIC_ASSESSMENT Eye disorders None View
Superficial punctate keratitis (SPK) SYSTEMATIC_ASSESSMENT Eye disorders None View