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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:40 AM
NCT ID: NCT01660802
Description: The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.
Frequency Threshold: 5
Time Frame: None
Study: NCT01660802
Study Brief: Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
700 μg Dexamethasone 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. None None 1 129 69 129 View
Sham Sham administered in the study eye on Day 1. None None 2 130 15 130 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 17.0 View
Cholecystitis Chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 17.0 View
Vitreous Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.0 View
Conjunctival Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17.0 View
Intraocular Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 17.0 View