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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT01618266
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01618266
Study Brief: Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ozurdex® (Dexamethasone Intravitreal Implant) dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment. None None 98 375 252 375 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 16.1 View
Pulmonary Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.1 View
Retinal Ischaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Herpetic Keratitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.1 View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 16.1 View
Acute Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 16.1 View
Coronary Artery Bypass SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 16.1 View
Pulmonary Arterial Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 16.1 View
Prostate tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 16.1 View
Ocular Hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Cataract Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 16.1 View
Vitreous Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 16.1 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.1 View
Macular Fibrosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 16.1 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 16.1 View
Subscapular Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Sudden Falls Due to Legs Giving Way NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 16.1 View
Diabetes SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 16.1 View
Detached Retina SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Cardiopulmonary Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 16.1 View
Macular Degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Benign Prostatic Hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 16.1 View
Infarction SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 16.1 View
Pulmonary Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.1 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular Hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 16.1 View