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 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
NCT ID:
NCT04177394
Description:
Rates are reported as number of patients with an event out of the total number of patients in the study.
Frequency Threshold:
5
Time Frame:
All-Cause Mortality and Adverse Events are reported through 30 days.
Study:
NCT04177394
Study Brief:
MitraClip EXPAND G4 Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MitraClip G4 System | Percutaneous mitral valve repair using the MitraClip G4 system MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system. | 16 | None | 209 | 1164 | 0 | 1164 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA OF CHRONIC DISEASE | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| LEFT VENTRICULAR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MITRAL PERFORATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MITRAL VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| CARDIAC COMPLICATION ASSOCIATED WITH DEVICE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ATRIAL SEPTAL DEFECT ACQUIRED | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIAC PERFORATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIOGENIC SHOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MITRAL VALVE STENOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MYOCARDIAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| TRICUSPID VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DEVICE CAPTURING ISSUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| CARDIAC INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| PNEUMOTHORAX TRAUMATIC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| PROCEDURAL HYPOTENSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| VASCULAR ACCESS COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| VASCULAR PROCEDURE COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| MEAN ARTERIAL PRESSURE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| OXYGEN SATURATION DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| METABOLISM AND NUTRITION DISORDERS | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| METABOLIC ACIDOSIS | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| MOBILITY DECREASED | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| METABOLIC ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| SIMPLE PARTIAL SEIZURES | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| UNRESPONSIVE TO STIMULI | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PULMONARY HYPERTENSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
Other Events(If Any):