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 @ 12:17 PM
Ignite Modification Date: 2025-12-25 @ 12:02 PM
NCT ID: NCT03017261
Description: AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use. SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
Frequency Threshold: 0
Time Frame: 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
Study: NCT03017261
Study Brief: TSolution One® Total Knee Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TSolution One® This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. 0 None 12 115 55 115 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stiffness of the joint SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hip Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Finger Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Phimosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gastrointestinal Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-malignant asbestosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Proctocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Breast Cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anal Fissure SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bleeding, unrelated to surgical site/procedure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Delayed Wound Healing SYSTEMATIC_ASSESSMENT General disorders None View
Dental Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dental Pain SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty Breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Effusion SYSTEMATIC_ASSESSMENT General disorders None View
Exacerbation of anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Generalized anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Index knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Index knee pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Insect bite SYSTEMATIC_ASSESSMENT General disorders None View
Nasal polyps SYSTEMATIC_ASSESSMENT General disorders None View
MCL Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lichen Sclerosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Kidney Stone SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-index knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pressure sores SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Retained device pins SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seroma SYSTEMATIC_ASSESSMENT General disorders None View
Seroma SYSTEMATIC_ASSESSMENT General disorders None View
Systemic Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Surgical Incision Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Thigh pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Temporary hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Toe fungus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Umbilical hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening of Parkinson's Disease SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain (other musculoskeletal) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain (other musculoskeletal) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View