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: 2025-12-25 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:55 PM
NCT ID: NCT00698867
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Study: NCT00698867
Study Brief: A Clinical Investigation of the Discovery™ Elbow 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
Discovery™ Elbow Discovery™ Elbow minimally constrained None None 17 118 32 118 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection requiring intervention NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post-op Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non-elbow Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Failed Ulnar Bushing NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left shoulder arthroplasty due to rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Humeral Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sucutaneous Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
GI Bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loosening of total elbow NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elbow Contracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Resection of Distal Ulna NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fracture Near Operative Site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Patient Fell NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stitch Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Olecranon and Triceps Deficiency NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Motor Vehicle Accident NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lung Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Elbow Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Perforation Anterior Medical Proximal Ulna NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ulnar Neuropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foreign Body Reaction/Excision Olecranon Mass NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elbow Squeaking NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MCP Replacement NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Coagulase Negative Staph Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Posterior Screw Backing Out NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Humeral radiolucency NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Humeral Component Loosening NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Posterior Nerve Palsy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Painful Lateral Elbow NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leukemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Wound Drainage NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Olecranon Impingement NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insidious Onset Edema Elbow NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ectopic Bone Formation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elbow Contracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View