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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT02006693
Description: The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
Frequency Threshold: 5
Time Frame: Up to 26 Months
Study: NCT02006693
Study Brief: Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
XEN® Gel Stent The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. 2 None 12 120 14 120 View
XEN® Gel Stent With Cataract Surgery The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. 2 None 6 98 8 98 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Heart attack SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cataract aggravated SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Retinal disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Implant site dehiscence SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Decompensated cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Broken hip SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Intraocular pressure high SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Intraocular pressure high - fellow eye SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Kidney tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Oral cancer stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Stomach cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Trabeculectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyphema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Trabeculectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
YAG (yttrium-aluminum-garnet) laser surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View