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 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:56 AM
NCT ID: NCT05329402
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT05329402
Study Brief: Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Disposable Powered Articulating Endoscopic Linear Cutter Stapler The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. 0 None 10 79 44 79 View
ECHELON Flex Powered Articulating Endoscopic Linear Cutters ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. 0 None 8 83 54 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary artery bleeding SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aerodermectasia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thoracic wall lung hernia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lung leak gas SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
left chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left lower lung with residual pulmonary atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders None View
Abnormal liver function SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chylopleura SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
aypnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
others SYSTEMATIC_ASSESSMENT General disorders None View