Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:23 PM
NCT ID: NCT03431857
Description: Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Frequency Threshold: 0.5
Time Frame: Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study.
Study: NCT03431857
Study Brief: Multi Centre Study on TESS V2 Shoulder 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
TESS V2 Prosthesis Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis. 5 None 44 106 16 106 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture thoracical vertebrae SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lung edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Knee wound SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pubis bone fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wrist fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Humerus fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pseudoarthritis rhizomelic SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuropathy and athrosis of inferior limbs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Radius fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoporosis, fractures SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acromio-clavicular arthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rachialgia and scapulalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cubital and Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Humerocubital ostephytes SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dementia + respiratory infection SYSTEMATIC_ASSESSMENT General disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Stress incontinence SYSTEMATIC_ASSESSMENT General disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vitrectomy SYSTEMATIC_ASSESSMENT Eye disorders None View
Head wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cement effraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Parkinson SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperalgic lumbosciatic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hand surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elbow arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stroke SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Revision SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Lumbar surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shoulder surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Screw breakage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heterotopic ossification SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain, paresthesia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Biceps rupture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Reflex sympathetic syndrom SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Postoperative inflammation suspected SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nerve injury SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acromion inflammation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acromial fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View