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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT03539458
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT03539458
Study Brief: Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Device Arm All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement 1 None 5 11 7 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Paravalvular Leak SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Arrhythmia or conduction disturbance SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Worsening Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Mesenteric Ischemia and Hemorrhagic Shock SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Stroke/TIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Respiratory insufficiency/Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Heart Failure treated with IV diuretics SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Vocal Cord Dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Arrhythmia or Conduction Disturbance SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View