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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:38 PM
NCT ID: NCT00530894
Description: None
Frequency Threshold: 5
Time Frame: 1 Year
Study: NCT00530894
Study Brief: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Risk: SAVR Surgical Aortic Valve Replacement None None 238 351 217 351 View
Inoperable: TAVR Edwards SAPIEN Transcatheter Heart Valve None None 134 179 140 179 View
Inoperable: Medical Therapy Medical management and/or balloon aortic valvuloplasty None None 151 179 103 179 View
High Risk: TAVR Edwards SAPIEN Transcatheter Heart Valve None None 228 348 230 348 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding event SYSTEMATIC_ASSESSMENT Vascular disorders STS/FDA View
Neurological event (including TIA stroke and psychomotor deficit) SYSTEMATIC_ASSESSMENT Nervous system disorders STS/AATS View
Other SYSTEMATIC_ASSESSMENT General disorders MedDRA 1+E21+E16:E40 View
Infection (including Endocarditis) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CHF SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Respiratory Event SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Gastro-Intestinal Event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Hemorrhagic/Vascular event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Abnormal Lab Values SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Conduction defects SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Angina SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Device embolization SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Aortic insufficiency without paravalvular leak SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
MI SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Perforation or damage to myocardium SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Device migration SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Perivalvular leak SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Mitral insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Access site nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Abnormal Lab Values SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Infection (including Endocarditis) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Respiratory Event SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Bleeding event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hemorrhagic/Vascular event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Gastro-Intestinal Event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
CHF SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Neurological event (including TIA stroke and psychomotor deficit) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View