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 @ 4:03 PM
Ignite Modification Date: 2025-12-25 @ 2:05 PM
NCT ID: NCT03752866
Description: The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
Frequency Threshold: 5
Time Frame: 30 days
Study: NCT03752866
Study Brief: CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Portico™ Valve, Delivery System(s) and Loading System(s) Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system. 16 None 348 501 72 501 View
Portico™ Valve, FlexNav Delivery and Loading System(s) Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems. 10 None 358 500 80 500 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Bleeding SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac Arrhythmias SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Thrombus On Device SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Valve Embolization SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Vascular Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Vessel Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Thrombus SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Aortic Valve Regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Complete Heart Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Death - Unknown SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
First Degree Heart Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Left Bundle Branch Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Mitral Valve Insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Paravalvular Leak SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Pericardial Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Second Degree Heart Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 11.0 View
Anemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Ischemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Weakness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Death - Unknown SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Multi Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Death - Unknown SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Multi Organ Failure SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Renal Insufficiency/Worsening Renal Function SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary Tract Infection/UTI SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Annulus Rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Valve Embolization SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Valve Migration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Death - Unknown SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Death - Unknown SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Transient Ischemic Attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Multi Organ Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal Insufficiency/Worsening Renal Function SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Access Site Bleeding Event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Death - Unknown SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Vascular Access Site And Access Related Complications SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Vascular Perforation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Left Bundle Branch Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View