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 @ 2:23 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT01473134
Description: Adverse Event Case Report Form (worksheet)
Frequency Threshold: 5
Time Frame: AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants).
Study: NCT01473134
Study Brief: Safety and Efficacy of the Oxford Cementless Partial Knee 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
Oxford Cemented Partial Knee Oxford Partial Knee applied WITH bone cement 9 None 10 114 53 114 View
Oxford Cementless Partial Knee Oxford Partial Knee implanted WITHOUT bone cement 3 None 17 207 114 207 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Avascular Necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bearing Dislocation/Disassociation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cellulitis/Redness/Blistering SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Deep Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Effusion/Swelling/Edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Femoral Implant Loosening SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hemarthrosis/Hemarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Loose body and/or Osteophyte Removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Ipsilateral Knee Related Adverse Event SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain (progressive/persistent) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Progressive Disease in Contralateral Compartment SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Subsidence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibial Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain (progressive/persistent) SYSTEMATIC_ASSESSMENT General disorders None View
Clicking/Popping/Crepitus/Grinding SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Effusion/Swelling/Edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Traumatic Injury (Study Knee) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Ipsilateral Knee Related Adverse Event SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View