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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01951066
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01951066
Study Brief: Diabetic Macular Edema Treated With Ozurdex (DMEO)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants None None None 4 20 11 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cataract progression None Eye disorders None View
Emergency room visit because of a possible seizure None Nervous system disorders None View
Mitral valve repair surgery None Cardiac disorders None View
Endophthalmitis None Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Foot Infection None Musculoskeletal and connective tissue disorders None View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders None View
Vision loss None Eye disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Patient had a fall None General disorders None View
Increased Intraocular pressure None Eye disorders None View
Eye soreness None Eye disorders None View
Bruising of eyelid None Eye disorders None View
Blood transfusion due to severe anemia None Blood and lymphatic system disorders None View
Steroid injection in the hip due to arthritis None Musculoskeletal and connective tissue disorders None View
Racing of heart None Cardiac disorders None View