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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT00289133
Description: Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
Frequency Threshold: 0
Time Frame: Intraoperatively and postoperatively through 6 years.
Study: NCT00289133
Study Brief: Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GVF Poly Gamma Vacuum Foil polyethylene tibial component None None 16 461 146 461 View
XLK Poly Cross-linked polyethylene tibial component None None 15 477 164 477 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Death SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other - Had fall and fractured left shoulder and had a concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Other - Flexion Instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - Left Hip Revision SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - Severe Low Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - Death SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other - Ovarian Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other - Stage 4 Terminal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other - Stage 4 Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other - Death SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other - Death SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 16.0 View
Other - Follow-up Left Knee Arthroscope SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Other - Glioblastoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other - Fall Injured Quad Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 16.0 View
Loosening SYSTEMATIC_ASSESSMENT Product Issues MedDRA 16.0 View
Central Nervous System SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Other-Syncope Weakness SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Central Nervous System SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other-Positive Nasal Culture for MRSA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Wound Problem SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Endocrine/Metabolic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Central Nervous System SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Endocrine/Metabolic SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Extensor Mechanism SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Feeling of Instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other-Follow-up right knee arthroscope SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Grade 1 Strain Medial Collateral Ligament SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other-Inflamed bursa over Gerdy's Tubercle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other-Mild Limp Secondary to Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Patella Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Patella Clunk SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Pes Bursitis; ITB syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Pesanserinus Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Pre Patellar Bursitis with Peri Patellar tenderness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Routine F/U to Bilateral knee arthroscopic debulking SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- F/U Right Knee Arthroscope SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
other- Right Ankle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Subject has continuous right knee pain (non-surgical knee) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Central Nervous System SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Peripheral Nervous System SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Respiratory System SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other- Dermis Contact Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Other- Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Other- Skin Rash on Low Bilateral Legs SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Wound Problem SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Other- Change in Insurance SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Peri-op AE - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Pain SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Thrombosis/Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Stiffness, Arthrofibrosis, Ankylosis, Limited Range of Motion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - Systemic: Voluntary Withdrawal SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 16.0 View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Endocrine/Metabolic SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 16.0 View
Central Nervous System SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Wound Problem SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Gastrointestinal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16.0 View
Hematological SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Hematological SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Other - Advanced Alzheimer's SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Product Issues MedDRA 16.0 View
Other - Radiographic subsidence of the femoral component - asymptomatic SYSTEMATIC_ASSESSMENT Product Issues MedDRA 16.0 View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Extensor Mechanism SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Other - Left knee artrhoscopy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Other - Atraumatic onset of right buttock pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Hemarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - 20 degree flexion contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - Bilateral knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - Bilateral hand numbness and pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other - Fell and injured quad SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other- Itchy Red Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View