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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT02762903
Description: None
Frequency Threshold: 0
Time Frame: Up to 1 year after surgery.
Study: NCT02762903
Study Brief: Lesser Tuberosity Osteotomy for Subscapularis Repair
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tenotomy Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. TSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures. Shoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. 0 None 0 30 2 30 View
Osteotomy Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. TSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures. Shoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. 0 None 0 30 5 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tear of Supraspinatus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Subacromial impingement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Transient post-operative radial nerve palsy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Subacromial bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trapezius spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View