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 @ 3:31 PM
Ignite Modification Date:
2025-12-25 @ 1:45 PM
NCT ID:
NCT02825992
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse Events were collected through 12 months post-procedure.
Study:
NCT02825992
Study Brief:
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| AcQMap System | Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation AcQMap System: 3D imaging and mapping system for cardiac chambers | 0 | None | 33 | 129 | 58 | 129 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| ATRIAL FLUTTER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| ATRIAL TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIAC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VASCULAR PSEUDOANEURYSM | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ARTERIOVENOUS FISTULA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| CARDIAC TAMPONADE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| MITRAL VALVE INCOMPETENCE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| SINUS ARREST | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| SINUS NODE DYSFUNCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| SUPRAVENTRICULAR TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| VENTRICULAR EXTRASYSTOLES | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| VENTRICULAR FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| CHEST DISCOMFORT | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INFLAMMATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| JAUNDICE | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| ARTERIOGRAM CORONARY | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| CATHETERISATION CARDIAC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| EJECTION FRACTION DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| MENINGIOMA | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| NEOPLASM RECURRENCE | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| CEREBROVASCULAR ACCIDENT | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| SYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HAEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| NEPHROLITHIASIS | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| URINARY RETENTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| PULMONARY MASS | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| ABDOMINAL HERNIA REPAIR | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| LYMPHOCELE | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| PERICARDIAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANGINA PECTORIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| PERICARDIAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| HYPERTHYROIDISM | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.1) | View |
| CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| LOWER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VASCULAR PSEUDOANEURYSM | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HAEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ARTERIOVENOUS FISTULA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HAEMATOMA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| INTRACARDIAC THROMBUS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| PERICARDITIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| BLINDNESS TRANSIENT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| ABDOMINAL DISTENSION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| INGUINAL HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| LARGE INTESTINE POLYP | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| OESOPHAGEAL ULCER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| TOOTH SOCKET HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ADMINISTRATION SITE ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| OEDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PUNCTURE SITE HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| CHOLELITHIASIS | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| STAPHYLOCOCCAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CONTUSION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| VASCULAR ACCESS SITE RUPTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| BLOOD CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| ELECTROCARDIOGRAM ABNORMAL | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| DIABETES MELLITUS | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| GOUT | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| MUSCULOSKELETAL CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| OSTEOARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| ATYPICAL FIBROXANTHOMA | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| LUNG NEOPLASM MALIGNANT | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| DYSARTHRIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HYPOAESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| URINARY RETENTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| HAEMOPTYSIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| PULMONARY CONGESTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ECCHYMOSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| CARDIAC ABLATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| KNEE ARTHROPLASTY | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| AIR EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| ARTERIAL OCCLUSIVE DISEASE | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| PHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| ERYTHEMA OF EXTREMITIES | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |