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 @ 4:40 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT02052466
Description: None
Frequency Threshold: 5
Time Frame: Minimum 2 years after surgery
Study: NCT02052466
Study Brief: Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reverse TSA Patients Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery. None None 6 30 0 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hip fracture due to fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders EPIC View
A-fib with rapid ventricular response NON_SYSTEMATIC_ASSESSMENT Cardiac disorders EPIC View
Transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Cardiac disorders EPIC View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations EPIC View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations EPIC View
Thiamine deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders EPIC View
Fracture of acromion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders EPIC View
Bladder tumor NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders EPIC View
External artery, common femoral, and profunda endarterectomy NON_SYSTEMATIC_ASSESSMENT Vascular disorders EPIC View
Other Events(If Any):