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 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
NCT ID:
NCT03016169
Description:
All AEs reported in the Trifecta GT PMCF study.
Frequency Threshold:
0
Time Frame:
5 Years
Study:
NCT03016169
Study Brief:
Trifecta™ GT Post Market Clinical Follow-up
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment | All subjects will receive the Trifecta GT valve Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve. | 54 | None | 206 | 358 | 82 | 358 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11) | View |
| MAJOR BLEEDING - OTHER BLEEDING | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11) | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| ENDOCARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| NONSTRUCTURAL DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| STRUCTURAL VALVE DETERIORATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11) | View |
| OTHER NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11) | View |
| MAJOR BLEEDING - GASTROINTESTINAL BLEED | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11) | View |
| ENDOCARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11) | View |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11) | View |
| MAJOR BLEEDING - OTHER BLEEDING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11) | View |
| OTHER NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11) | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| MAJOR BLEEDING - OTHER BLEEDING | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| OTHER NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| OTHER NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11) | View |
| MAJOR BLEEDING - UROLOGIC BLEEDING | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11) | View |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (11) | View |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11) | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |
| MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |
| MAJOR BLEEDING - OTHER BLEEDING | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |
| OTHER NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11) | View |
| NONSTRUCTURAL DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| STRUCTURAL VALVE DETERIORATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11) | View |
| MAJOR BLEEDING - GASTROINTESTINAL BLEED | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11) | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| OTHER NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11) | View |
| NONSTRUCTURAL DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11) | View |
| MAJOR BLEEDING - OTHER BLEEDING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11) | View |
| OTHER CARDIOVASCULAR | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |
| OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11) | View |