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 @ 3:35 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT03227692
Description: None
Frequency Threshold: 0
Time Frame: Surgery to 6 month postoperative visit
Study: NCT03227692
Study Brief: Persona TKA With iASSIST Knee System and iASSIST Knee System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Persona With iASSIST Knee Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone. 0 None 0 42 0 42 View
Persona Without iASSIST Knee Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. Persona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. 0 None 1 41 1 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Malignant Lymphoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postoperative Supracondylar Fracture of femur NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View