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 @ 9:46 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT00853632
Description: Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.
Frequency Threshold: 5
Time Frame: Events occurring from baseline through eight years of follow-up post implant.
Study: NCT00853632
Study Brief: Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
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 - CEP Mitral Valve Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. 88 None 281 329 206 329 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
BLEEDING - MAJOR SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
BLEEDING - MINOR SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANGINA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
AORTIC REGURGITATION (NATIVE) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC CONDUCTION DISTURBANCE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOVASCULAR - OTHER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOVASCULAR DISSECTION / TEAR / INJURY SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BONE FRACTURE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders None View
COAGULOPATHY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
DRUG REACTION SYSTEMATIC_ASSESSMENT General disorders None View
EDEMA SYSTEMATIC_ASSESSMENT General disorders None View
FEVER - UNKNOWN ORIGIN SYSTEMATIC_ASSESSMENT Infections and infestations None View
GASTRO-INTESTINAL COMPLICATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEMATOLOGICAL DISORDER SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
HEPATIC COMPLICATION SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT General disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT General disorders None View
INFECTION / INFLAMMATION SYSTEMATIC_ASSESSMENT Infections and infestations None View
METABOLIC COMPLICATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
MULTIPLE ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders None View
NEUROLOGICAL COMPLICATION SYSTEMATIC_ASSESSMENT General disorders None View
OTHER SYSTEMATIC_ASSESSMENT General disorders None View
PSYCHIATRIC COMPLICATION SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
RENAL COMPLICATION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RESPIRATORY COMPLICATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SEPTICEMIA SYSTEMATIC_ASSESSMENT General disorders None View
STERNAL / THORACIC WOUND COMPLICATION SYSTEMATIC_ASSESSMENT General disorders None View
SUDDEN DEATH SYSTEMATIC_ASSESSMENT General disorders None View
SUICIDE SYSTEMATIC_ASSESSMENT General disorders None View
SYNCOPE SYSTEMATIC_ASSESSMENT General disorders None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
VISION DISORDER SYSTEMATIC_ASSESSMENT Eye disorders None View
SVD - OTHER STRUCTURAL VALVE DETERIORATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SVD - STUDY VALVE CALCIFICATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ENDOCARDITIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NSVD - INAPPROPRIATE SIZING SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NSVD - PARAVALVULAR LEAK - MAJOR SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PNEUMOTHORAX / HEMOTHORAX SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SVD - STUDY VALVE WEAR SYSTEMATIC_ASSESSMENT Cardiac disorders None View
THROMBOEMBOLISM - NON-CEREBRAL SYSTEMATIC_ASSESSMENT Cardiac disorders None View
THROMBOEMBOLISM - STROKE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
THROMBOEMBOLISM - TIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
TRICUSPID REGURGITATION (NATIVE) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VALVE THROMBOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VASCULAR COMPLICATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VENTRICULAR RUPTURE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ABNORMAL LAB VALUES SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BLEEDING - MINOR SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC CONDUCTION DISTURBANCE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOVASCULAR - OTHER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ABNORMAL LAB VALUES SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
GASTRO-INTESTINAL COMPLICATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEMATOLOGICAL DISORDER SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT General disorders None View
INFECTION / INFLAMMATION SYSTEMATIC_ASSESSMENT Infections and infestations None View
NEUROLOGICAL COMPLICATION SYSTEMATIC_ASSESSMENT General disorders None View
OTHER SYSTEMATIC_ASSESSMENT General disorders None View
RENAL COMPLICATION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RESPIRATORY COMPLICATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View