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 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:42 PM
NCT ID: NCT02497950
Description: None
Frequency Threshold: 0
Time Frame: Up to 5 years
Study: NCT02497950
Study Brief: HeartMate 3 ELEVATE™ Registry
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ELEVATE Patients The ELEVATE study included 540 subjects of which: 463 pts received HM3 as primary implant and 19 pts received the HM3 as a replacement of another durable LVAD. These 2 groups ( 482 pts) consist the main study population, for which complete information has been collected. In addition, 58 patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) 209 None 407 482 277 482 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arterial Non-CNS Thromboembolism SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemolysis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Major Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Major Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurologic Dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric Episode SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal Dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Right Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Venous Thromboembolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other events SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac Arrhythmias SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hepatic Dysfunction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Fluid Collection SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hepatic Dysfunction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cardiac Arrhythmias SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Major Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Major Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurologic Dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pericardial Fluid Collection SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Psychiatric Episode SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal Dysfunction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Venous Thromboembolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Non Serious Events SYSTEMATIC_ASSESSMENT General disorders None View