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 @ 4:10 AM
Ignite Modification Date: 2025-12-26 @ 3:08 AM
NCT ID: NCT02097420
Description: None
Frequency Threshold: 0
Time Frame: 60 months
Study: NCT02097420
Study Brief: HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Device Arm: Mitral Valve Replacement Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions 6 None 19 23 11 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemias SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abnormal Coagulation Parameter SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LVOT Resection with Resection of Subaortic Membrane Myotomy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left Ventricle Outflow Tract Observation w/ Subaortic Obstruction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Third Degree Heart Block (Complete Heart Block) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multiple Organ Failure SYSTEMATIC_ASSESSMENT General disorders None View
Perivalvular Leak SYSTEMATIC_ASSESSMENT General disorders None View
Bacterial Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Common Cold/Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abnormal Chest X-Ray SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypervolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Respiratory Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Thrombus on Device SYSTEMATIC_ASSESSMENT Product Issues None View
Acute Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Subdural Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intracerebral Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Left Ventricular Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral Valve Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Moderate Left Ventricular (LV) Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pseudoaneurysm on Left Ventricular Free Wall SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Shock Related to Presumed Pneumotosis/Nec SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Lab Value SYSTEMATIC_ASSESSMENT Investigations None View
Generalized Tonic-Clonic Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Prosthetic Mitral Valve Dysfunction SYSTEMATIC_ASSESSMENT Product Issues None View
Thrombus SYSTEMATIC_ASSESSMENT Product Issues None View
G-Tube Procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intraparenchymal Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Subdural Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated RV Pressure and Pulmonary Vasculature Resistance SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infective/Bacterial Endocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Junctional Escape Rhythm/Intermittent Junctional Rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LVOT Resection SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral Valve Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abnormal Coagulation Parameter SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemias SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Augmentation of Ascending Aorta with Pulmonary Homograft SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Progressive LVOT Obstruction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ST Segment Changes SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus Node Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Third Degree Heart Block (Complete Heart Block) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Valve Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Common Cold/Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abnormal Lab Value SYSTEMATIC_ASSESSMENT Investigations None View
Elevated ALT Levels SYSTEMATIC_ASSESSMENT Investigations None View
Elevated AST Levels SYSTEMATIC_ASSESSMENT Investigations None View
Elevated Plasma Free Hemoglobin SYSTEMATIC_ASSESSMENT Investigations None View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elective Procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elective Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Reoperation for Subaortic Stenosis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Vascular disorders None View