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 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT00764504
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00764504
Study Brief: Reverse Shoulder Prosthesis Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Continued Access Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder. None None 0 249 157 249 View
Primary Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. None None 0 156 116 156 View
Revision Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device. None None 0 162 113 162 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia / Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Broken Device / Component SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Broken Screw SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cancer SYSTEMATIC_ASSESSMENT Immune system disorders None View
Death - Natural Causes SYSTEMATIC_ASSESSMENT Social circumstances None View
Device Instability / Failure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heart Complications SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurological disorder and numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View