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 @ 6:54 PM
Ignite Modification Date:
2025-12-25 @ 4:27 PM
NCT ID:
NCT03227757
Description:
None
Frequency Threshold:
0
Time Frame:
3 years
Study:
NCT03227757
Study Brief:
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tricuspid Valve Repair System | Subjects who received TVRS will be included in this arm. Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. | 25 | None | 68 | 98 | 88 | 98 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| DISSEMINATED INTRAVASCULAR COAGULATION | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| HAEMORRHAGIC DIATHESIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ATRIOVENTRICULAR BLOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| Cardiorenal syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| LEFT VENTRICULAR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MITRAL VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| TACHYARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Tricuspid valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15 | View |
| Gastritis haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15 | View |
| Intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15 | View |
| Oesophagitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| UMBILICAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15 | View |
| DEVICE DEPLOYMENT ISSUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| DEVICE MALFUNCTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15 | View |
| POLYP | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| SUDDEN DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15 | View |
| CORONA VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Gallbladder empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| PNEUMONIA VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15 | View |
| BRAIN CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| BURNS SECOND DEGREE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| CRANIOCEREBRAL INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| MULTIPLE INJURIES | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| SPINAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| THORACIC VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15 | View |
| Vascular pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15 | View |
| Blood sodium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| FLUID RETENTION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15 | View |
| BREAST CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| BREAST CANCER RECURRENT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | View |
| METASTATIC NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| MYELOPROLIFERATIVE DISORDER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| SKIN CANCER | 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 |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15 | View |
| VIITH NERVE PARALYSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | 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 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| ARRHYTHMIA PROPHYLAXIS | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| Arteriovenous fistula | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| Femoral arterial stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| VENOUS INSUFFICIENCY | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| BUNDLE BRANCH BLOCK RIGHT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CARDIORENAL SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CHORDAE TENDINAE RUPTURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15 | View |
| INTRACARDIAC THROMBUS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| LEFT VENTRICULAR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MITRAL VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| SICK SINUS SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| TACHYARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| TRICUSPID VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| SUDDEN HEARING LOSS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| TYMPANIC MEMBRANE PERFORATION | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| VESTIBULAR DISORDER | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| HYPERTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (15.0) | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| GLAUCOMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| GASTRITIS HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| INTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| OESOPHAGEAL STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| OESOPHAGITIS ULCERATIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| TOOTH DISORDER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| UMBILICAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| CATHETER SITE HAEMATOMA | 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 |
| DEVICE DEPLOYMENT ISSUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| DEVICE MALFUNCTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| IMPAIRED HEALING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| MULTI-ORGAN FAILURE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| POLYP | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| SUDDEN DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| THROMBOSIS IN DEVICE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| CHOLESTASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| LIVER INJURY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| SEASONAL ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.0) | View |
| BACTERIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| BRONCHOPNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| CORNEAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| CORONA VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| GALLBLADDER EMPYEMA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| PNEUMONIA VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15 | View |
| ARTHROPOD STING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| BRAIN CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| BURNS SECOND DEGREE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| CRANIOCEREBRAL INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| HAND FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| JOINT DISLOCATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| LIMB INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| MULTIPLE INJURIES | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| PROCEDURAL NAUSEA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| SPINAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| THERMAL BURN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| THORACIC VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| TRAUMATIC HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| VASCULAR PSEUDOANEURYSM | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| BLOOD PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| BLOOD SODIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| CARDIOACTIVE DRUG LEVEL DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| COAGULATION FACTOR DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| HEART RATE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| OCCULT BLOOD | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| OXYGEN SATURATION DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| FAILURE TO THRIVE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| FLUID RETENTION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| GOUT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| TYPE 1 DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| LIMB DISCOMFORT | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| MUSCULOSKELETAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| TRIGGER FINGER | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| ADRENAL NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| BREAST CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| BREAST CANCER RECURRENT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| COLON CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| METASTATIC NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| MYELOPROLIFERATIVE DISORDER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| SEBORRHOEIC KERATOSIS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| SKIN CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| ANOSMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| CARPAL TUNNEL SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 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 |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| MYOCLONUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| POLYNEUROPATHY | 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 |
| VIITH NERVE PARALYSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| VOCAL CORD PARALYSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| ANXIETY DISORDER DUE TO A GENERAL MEDICAL CONDITION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| BREAST PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| GYNAECOMASTIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| ACUTE PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal 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 |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPHONIA | 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 |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| HYPERVENTILATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| HYPOVENTILATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PLEURISY | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| UPPER-AIRWAY COUGH SYNDROME | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DERMAL CYST | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| PSORIASIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| ARRHYTHMIA PROPHYLAXIS | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| STOMACH DILATION PROCEDURE | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| ARTERIOVENOUS FISTULA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| FEMORAL ARTERIAL STENOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HYPERTENSIVE CRISIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15 | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| VENOUS INSUFFICIENCY | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HAEMOLYTIC ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| HAEMORRHAGIC DIATHESIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| IRON DEFICIENCY ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ATRIOVENTRICULAR BLOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ANAEMIA MACROCYTIC | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| DISSEMINATED INTRAVASCULAR COAGULATION | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |