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 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT04443218
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT04443218
Study Brief: Edwards PASCAL Transcatheter Valve Repair System 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
Edwards PASCAL Transcatheter Mitral Valve Repair System Mitral valve repair with PASCAL implanted via transcatheter procedure 19 None 82 220 0 220 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders STS/ACC TVT Registry View
Readmission - Cardiac (not Heart Failure) SYSTEMATIC_ASSESSMENT Cardiac disorders STS/ACC TVT Registry View
Readmission - Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders STS/ACC TVT Registry View
Atrial Septal Defect (ASD) Closure Due to Transseptal Catheterizaton SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications STS/ACC TVT Registry View
Bleeding at Access Site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications STS/ACC TVT Registry View
Hematoma at Access Site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications STS/ACC TVT Registry View
Major Vascular Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications STS/ACC TVT Registry View
Other Device Related Event SYSTEMATIC_ASSESSMENT Product Issues STS/ACC TVT Registry View
Single Leaflet Device Attachment SYSTEMATIC_ASSESSMENT Product Issues STS/ACC TVT Registry View
New Requirement for Dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders STS/ACC TVT Registry View
Complication Requiring Transcatheter or Surgical Intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures STS/ACC TVT Registry View
Mitral Valve Re-Intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures STS/ACC TVT Registry View
Readmission - Non-Cardiac (Follow Up) SYSTEMATIC_ASSESSMENT Surgical and medical procedures STS/ACC TVT Registry View
Unplanned Other Cardiac Surgery or Intervention (Not Mitral Valve Re-Intervention) SYSTEMATIC_ASSESSMENT Surgical and medical procedures STS/ACC TVT Registry View
Unplanned Vascular Surgery or Intervention (for Bleeding or Access Site Complication) SYSTEMATIC_ASSESSMENT Surgical and medical procedures STS/ACC TVT Registry View
Life-Threatening Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders STS/ACC TVT Registry View
Major Bleeding Event SYSTEMATIC_ASSESSMENT Vascular disorders STS/ACC TVT Registry View
Other Bleed SYSTEMATIC_ASSESSMENT Vascular disorders STS/ACC TVT Registry View
Other Events(If Any):