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 @ 3:02 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT01936259
Description: Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
Frequency Threshold: 0
Time Frame: All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years.
Study: NCT01936259
Study Brief: Comprehensive Shoulder System Nano IDE
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Comprehensive Mini Humeral Stem This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem). 2 None 55 130 118 130 View
Comprehensive Nano Humeral Component This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component). 3 None 41 131 105 131 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Implant or Part Failure or Fracture SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other General (Non-Shoulder Related) Complication SYSTEMATIC_ASSESSMENT General disorders None View
Dislocation / Subluxation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death (Non-Shoulder Related) SYSTEMATIC_ASSESSMENT General disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Shoulder-Related Complication SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nerve Injury SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other General (Non-Shoulder Related) Complication SYSTEMATIC_ASSESSMENT General disorders None View
Delayed Wound Healing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dislocation / Subluxation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Humeral Fracture or Perforation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Implant or Part Failure or Fracture SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Inadequate Range of Motion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Loosening or Migration of Implants or Parts SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nerve Deficit SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unusual Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound Problems: Dehiscence, Necrosis, Drainage, Superficial Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Shoulder-Related Complication SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View