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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT04580160
Description: None
Frequency Threshold: 0
Time Frame: Summary of adverse events that have been reported through 390 days
Study: NCT04580160
Study Brief: Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent 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
Duo Venous Stent System Use of the Duo Venous Stent System in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. 2 None 46 162 102 162 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac Disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congenital, familial and genetic disorders SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pregnancy, puerperium and perinatal conditions SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Product issues SYSTEMATIC_ASSESSMENT Product Issues None View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Surgical and medical procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear and labyrinth disorders SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congenital, familial and genetic disorders SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Immune system disorders SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Investigations SYSTEMATIC_ASSESSMENT Investigations None View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pregnancy, puerperium and perinatal conditions SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Product issues SYSTEMATIC_ASSESSMENT Product Issues None View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Surgical and medical procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View