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 @ 12:03 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT02527161
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT02527161
Study Brief: Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ShapeMatch Cutting Guides With Triathlon Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides. 1 None 48 96 47 96 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-Operative site NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Operative site NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-Operative site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Operative Site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Operative site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Non-operative side NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Non-operative site NON_SYSTEMATIC_ASSESSMENT General disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View