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 @ 3:45 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT02434692
Description: SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
Frequency Threshold: 5
Time Frame: Evaluation over 12 months follow-up period.
Study: NCT02434692
Study Brief: Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Set In this multicenter, open-label, single-arm, interventional clinical trial a total of 24 patients with primary open angle glaucoma were initially enrolled, 22 of whom successfully received the ARGOS-IO implant. Of the two patients, initially enrolled but not implanted with the ARGOS-IO implant, one patient was included due to a misunderstanding of the inclusion and exclusion criteria, which was noticed before the procedure. 23 patients were thus included in the safety evaluation set ("Safety Set"-Group). Due to surgical complications during cataract surgery, an implantation of the ARGOS-IO pressure sensor was not attempted in the second patient. 0 None 9 23 23 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abnormal visual field test SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber fibrin SYSTEMATIC_ASSESSMENT Eye disorders None View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Amaurosis fugax SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal decompensation SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract operation in fellow eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber inflammation SYSTEMATIC_ASSESSMENT Eye disorders None View
Pigment dispersion SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber fibrin SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal endothelial cell loss SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal pigmentation SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Iris prolapse SYSTEMATIC_ASSESSMENT Eye disorders None View
Iris transillumination defect SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Posterior capsule opafication SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual field test abnormal SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctival edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal erosion SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Foreign body sensation in eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Glare SYSTEMATIC_ASSESSMENT Eye disorders None View
Pupils unequal SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders None View