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 @ 12:56 AM
Ignite Modification Date: 2025-12-25 @ 11:11 PM
NCT ID: NCT01789567
Description: SAEs were adjudicated per VARC2 definitions.
Frequency Threshold: 0
Time Frame: Adverse event data were collected up to 1 year post-implant procedure.
Study: NCT01789567
Study Brief: Engager Direct Aortic Clinical Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Engager™ Aortic Valve Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach None None 20 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia (Hgb<10g or Hct<30%) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrio-ventricular block, 3 degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other implantation/catheterization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other cardiac event SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Life threatening or disabling bleed event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Major bleeding event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Multi organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis, confirmed (positive blood culture) SYSTEMATIC_ASSESSMENT General disorders None View
Other gastrointestinal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Life threatening or disabling bleed event SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Major bleeding event SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Misplacement of the Engager Valve SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Perforation of the heart SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other SYSTEMATIC_ASSESSMENT Investigations None View
Cancer/malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury: stage 3 SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Life threatening or disabling bleed event SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Major ascending aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia (Hgb<10g or Hct<30%) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LBBB SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion, non-hemorrhagic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Minor bleeding event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT Investigations None View
Other gastrointestinal SYSTEMATIC_ASSESSMENT Investigations None View
Other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other respiratory/pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hemolysis: minor SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other hematologic/oncologic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrio-ventricular block, 1 degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other respiratory/pulmonary SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus bradycardia (<50 bpm) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular premature beats SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Congestive heart failure SYSTEMATIC_ASSESSMENT Investigations None View
Other renal SYSTEMATIC_ASSESSMENT Investigations None View
Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other central nervous system SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bronchospasm/asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Minor bleeding event SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other cardiac event SYSTEMATIC_ASSESSMENT Vascular disorders None View