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 @ 7:43 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT02343003
Description: A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02343003
Study Brief: Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of 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 Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe None None 3 76 43 76 View
Corticosteroid Injection Corticosteroid injections will be administered to study subjects' knees to reduce knee pain Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain None None 9 75 25 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
urogenital SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
other SYSTEMATIC_ASSESSMENT General disorders None View
procedure SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
extremities SYSTEMATIC_ASSESSMENT General disorders None View
blood/lymphatic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
endocrine/metabolic SYSTEMATIC_ASSESSMENT Endocrine disorders None View
gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
head, eyes, ears, nose, throat SYSTEMATIC_ASSESSMENT General disorders None View
musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
urogenital SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
other SYSTEMATIC_ASSESSMENT General disorders None View