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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT02687035
Description: This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Frequency Threshold: 5
Time Frame: All events are reported at 1 year.
Study: NCT02687035
Study Brief: PARTNER II Trial: S3iCAP
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SAPIEN 3 Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system. 87 None 818 1814 0 1814 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Conduction/native pacer disturbance requiring pacemaker SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-valve Related Readmission SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Unplanned Vascular Surgery or Intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ischemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Perforation with or w/o Tamponade SYSTEMATIC_ASSESSMENT Vascular disorders None View
Major Vascular Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Unplanned Other Cardiac Surgery or Intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Percutaneous Coronary Intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Conduction/native pacer disturbance requiring Implantable Cardioverter Defibrillator SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Major Bleeding Event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Retroperitoneal Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic Dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Valve Related Readmission SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Coronary Compression or Obstruction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Life Threatening Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Undetermined Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
New Requirement for Dialysis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hemorrhagic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Annular Dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Device Embolization Left Ventricle SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic Valve Re-intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):