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 @ 10:47 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT02058069
Description: Participants = knees
Frequency Threshold: 5
Time Frame: Subject enrollment to end of study.
Study: NCT02058069
Study Brief: Robotic Arm Assisted 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
Robotic Assisted Total Knee Arthroplasty Participants who underwent primary total knee arthroplasty using the Mako robotic arm system. Note regarding serious AEs: Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient's overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device. None None 9 100 0 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arthrofibrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Adhesions NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):