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: 2025-12-26 @ 2:41 PM
Ignite Modification Date: 2025-12-26 @ 2:41 PM
NCT ID: NCT04773106
Description: SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to foetal distress, foetal death or a congenital abnormality or birth defect
Frequency Threshold: 5
Time Frame: Day 360 to Day 1080 (V09 to V13). In Germany the term SAE is defined according to ยง2 Section 5 MPSV.
Study: NCT04773106
Study Brief: Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ARGOS-SC Sensor ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery. ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery. 1 None 7 22 13 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Pain and fluid accumulation in the abdominal cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pleuritis sicca SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization b/o nose surgery (removal of polyps) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Intestinal inflammation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac stent implantation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Death, non-related SYSTEMATIC_ASSESSMENT General disorders None View
Gastroenterological complaints SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bone fracture, upper arm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
COVID-19 infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Increased intraocular pressure SYSTEMATIC_ASSESSMENT Investigations None View
Increased intraocular pressure -non-study eye- SYSTEMATIC_ASSESSMENT Investigations None View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders None View