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 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
NCT ID:
NCT00676520
Description:
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
Frequency Threshold:
5
Time Frame:
1 year
Study:
NCT00676520
Study Brief:
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Subjects Receiving the XIENCE V EECSS | None | None | None | 1656 | 4952 | 478 | 4952 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Generalised edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Infusion site phlebitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Hypertensive encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Acute pulmonary edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Aortic valve disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Aortic valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Arteriospasm coronary | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Atrial thrombosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardiac tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Congestive cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Coronary artery dissection | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Coronary artery perforation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Coronary artery thrombosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Electromechanical dissociation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Ischaemic cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Low cardiac output syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Mitral valve calcification | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Mitral valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Pericardial haemorrhage | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Post procedural myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Sinus arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Sinus arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Sudden cardiac death | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Tricuspid valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Catheter site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Catheter site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Drug withdrawal syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Exercise tolerance decreased | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Edema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Systemic inflammatory response syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Contrast media reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (11.0) | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (11.0) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (11.0) | View |
| Coronary artery reocclusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Coronary artery restenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Implantable defibrillator malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| In-stent arterial restenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| In-stent coronary artery restenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Incision site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Lead dislodgement | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Mechanical complication of implant | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Other injuries | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Pacemaker complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Post procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Post procedural haemorrhagen | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Reperfusion injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Stent-graft endoleak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Thrombosis in device | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Vessel perforation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Weaning failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Anoxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Carotid sinus syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Complex partial seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Embolic cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Embolic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Facial palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Facial paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Hypoglycaemic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Moyamoya disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Neurological symptom | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Neuromyelitis optica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Spondylitic myelopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Syncope vasovagal | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Unresponsive to stimulie | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Vertebrobasilar insufficiency | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| Ear and labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.0) | View |
| Endocrine disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.0) | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Hepatobiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.0) | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Metabolism and nutrition disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
| Other renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| Acute pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Dyspnoea paroxysmal nocturnal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Orthopnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pickwickian syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pulmonary mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Respiratory arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Respiratory depression | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Throat tightness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Accelerated hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Aortic aneurysms | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Aortic aneurysm rupture | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Aortic dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Arterial thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Arteriovenous malformation | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Carotid artery disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Carotid artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Femoral arterial stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Femoral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Hypovolaemic shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Iliac artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Intermittent claudication | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Labile blood pressure | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Muscle haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Oesophageal varices haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Renal artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Renal artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Retroperitoneal haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Subclavian artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Vascular insufficiency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Vascular pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Aortic intramural haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |