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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT02961894
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02961894
Study Brief: Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Revolution Treatment Arm This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System. Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options. 3 None 26 121 78 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clinically Driven TLR SYSTEMATIC_ASSESSMENT Vascular disorders None View
Major target limb amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Perforation of target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Distal embolization SYSTEMATIC_ASSESSMENT Vascular disorders None View
All-cause mortality SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other 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
Endocrine disorders SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Hepatobiliary disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations 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
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
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
Surgical and medical procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View