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: 2025-12-24 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT02260869
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.
Study: NCT02260869
Study Brief: Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cooled Radiofrequency Ablation Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe 0 None 2 38 18 38 View
Monopolar Radiofrequency Ablation Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge) 0 None 4 37 20 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Broken Left Femur SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Worsening of reflux esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Knee Pain or Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruised body parts SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Respiratory tract infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscular issues SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View