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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:19 AM
NCT ID: NCT01903720
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01903720
Study Brief: A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch 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® OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months. None None 2 71 44 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View