Adverse Events Module

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 @ 12:30 AM
Ignite Modification Date: 2025-12-25 @ 10:37 PM
NCT ID: NCT03041467
Description: All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
Frequency Threshold: 5
Time Frame: All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
Study: NCT03041467
Study Brief: IN.PACTâ„¢ AV Access IDE 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
IN.PACT AV DCB PTA will be performed using the IN.PACT AV Drug Coated Balloon. IN.PACT AV DCB: IN.PACTâ„¢ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon 59 None 148 170 31 170 View
Standard Balloon Angioplasty PTA will be performed using a commercially available uncoated PTA balloon. Standard Balloon Angioplasty: Standard PTA Balloon 60 None 143 160 32 160 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Toxic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
End Stage Renal Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Renal Cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Renal Mass SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Benign Prostatic Hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.0 View
Acute Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Asphyxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Dyspnoea Exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Respiratory Arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Acute Generalised Exanthematous Pustulosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Dermal Cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Dermatitis Exfoliative Generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Diabetic Foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Erythema Multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Ischaemic Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Skin Mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Intervertebral Disc Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Leg Amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Peripheral Revascularisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Renal Transplant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Aortic Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Aortic Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Arteriovenous Fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Brachiocephalic Vein Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Dry Gangrene SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Extremity Necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypertensive Emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypertensive Urgency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Venous Thrombosis Limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Venous Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Atrioventricular Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac Failure Acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac Failure Chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Chronic Left Ventricular Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Coronary Artery Occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Diastolic Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Ischaemic Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Mitral Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Myocardial Ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Faeces Discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastric Polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastrointestinal Necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Intestinal Ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Intra-Abdominal Haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Ischaemic Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Large Intestinal Stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Large Intestine Polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Lower Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Strangulated Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Vascular Stent Occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Vascular Stent Stenosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Bile Duct Stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Hepatic Cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Hepatic Failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Kidney Transplant Rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
Abdominal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Acinetobacter Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Anal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Bacterial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Intervertebral Discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Klebsiella Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Necrotising Fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Coronary Artery Restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Femoral Neck Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Foot Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Toxicity To Various Agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Ulna Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Upper Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Vascular Access Malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Vascular Access Site Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Vascular Graft Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Vascular Graft Occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Anticoagulation Drug Level Below Therapeutic SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood Pressure Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Brain Natriuretic Peptide Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Occult Blood SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Troponin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Device Malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA 25.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Delirium Tremens SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Mental Status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Loss Of Personal Independence In Daily Activities SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 25.0 View
Refusal Of Treatment By Patient SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 25.0 View
Arteriovenous Fistula Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Cardiac Pacemaker Replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Dialysis Device Insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Intermittent Claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral Arterial Occlusive Disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral Artery Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral Artery Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral Vascular Disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral Vein Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Secondary Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Shock Haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Steal Syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Subclavian Artery Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Subclavian Vein Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Subclavian Vein Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Subclavian Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Superior Vena Cava Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Oesophageal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Dementia Alzheimer's Type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Lung Adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Metastases To Peritoneum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Myelodysplastic Syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Parathyroid Tumour Benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Pituitary Tumour Benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Prostate Cancer Metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Renal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Transitional Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Brain Stem Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Carotid Artery Stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cerebral Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cervical Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cognitive Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cubital Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Haemorrhagic Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Haemorrhagic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Hepatic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Hypertensive Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Lacunar Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Metabolic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Myelopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Narcolepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Spondylitic Myelopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Thrombotic Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Anaemia Of Chronic Disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Blood Loss Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Nephrogenic Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Acute Left Ventricular Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Aortic Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Aortic Valve Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Arteriosclerosis Coronary Artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Pulseless Electrical Activity SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Acetylcholinesterase Deficiency SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 25.0 View
Deafness Neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
Hyperparathyroidism Secondary SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Vitreous Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Colitis Ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diabetic Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diverticulum Intestinal Haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Mesenteric Arterial Occlusion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Mesenteric Haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Portal Hypertensive Gastropathy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Upper Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Complication Associated With Device SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Multiple Organ Dysfunction Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Peripheral Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Physical Deconditioning SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Stent-Graft Endoleak SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Arteriovenous Fistula Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Arteriovenous Graft Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Arthritis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Clostridium Difficile Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Coronavirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Covid-19 Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cytomegalovirus Enteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Enterococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Escherichia Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Escherichia Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Groin Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Infected Dermal Cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Infected Skin Ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Portal Pyaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pulmonary Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pustule SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Respiratory Syncytial Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Staphylococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Staphylococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Staphylococcal Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Staphylococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary Tract Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Wound Infection Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Wound Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Acetabulum Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Anastomotic Stenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Ankle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Fistula Aneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Fistula Occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Fistula Site Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Fistula Site Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Fistula Site Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Fistula Site Pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Fistula Thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Graft Site Pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Arteriovenous Graft Site Stenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Burns Second Degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Complications Of Transplanted Kidney SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Haemodialysis Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Humerus Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Inadequate Haemodialysis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Incarcerated Incisional Hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Joint Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Multiple Fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Pelvic Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Radius Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Rectal Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Shunt Malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Skull Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Subdural Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Failure To Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Lactic Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Type 2 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Arthritis Reactive SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Chondrocalcinosis Pyrophosphate SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Foot Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Lumbar Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Spinal Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Angiosarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Bladder Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Breast Angiosarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Cholesteatoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Colon Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Hepatic Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arteriovenous Fistula Site Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View