Adverse Events Module

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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 @ 12:45 PM
Ignite Modification Date: 2025-12-25 @ 12:14 PM
NCT ID: NCT02510261
Description: Safety analysis set included all the enrolled participants who received at least 1 dose of patisiran in this study.
Frequency Threshold: 5
Time Frame: First dose up to 28 days after last dose of study drug (approximately 5.6 years)
Study: NCT02510261
Study Brief: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prior Placebo Group of Study 004 Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months. 19 None 39 49 47 49 View
Prior Patisiran Group of Study 004 Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months. 21 None 82 137 135 137 View
Prior Patisiran Group of Study 003 Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months. 1 None 12 25 25 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ocular Surface Squamous Neoplasia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Oncocytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Autonomic Nervous System Imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Basal Ganglia Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hypoxic-ischaemic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Psychomotor Skills Impaired SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Subarachnoid Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Device Capturing Issue SYSTEMATIC_ASSESSMENT Product Issues MedDRA 23.0 View
Device Physical Property Issue SYSTEMATIC_ASSESSMENT Product Issues MedDRA 23.0 View
Device Power Source Issue SYSTEMATIC_ASSESSMENT Product Issues MedDRA 23.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Conversion Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Calculus Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
End Stage Renal Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Neurogenic Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urethral Haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary Bladder Haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Benign Prostatic Hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Acute Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acute Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Choking SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Hypoventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory Acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory Arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Sleep Apnoea Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Disability SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 23.0 View
Rehabilitation Therapy SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypovolaemic Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Neurogenic Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Poor Peripheral Circulation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Shock Haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Varicose Vein SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrioventricular Block Second Degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Amyloidosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Conduction Disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Pulseless Electrical Activity SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Restrictive Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Sinus Node Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Familial Amyloidosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 23.0 View
Hereditary Neuropathic Amyloidosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 23.0 View
Sudden Hearing Loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo Positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Corneal Perforation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Deposit Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Retinal Artery Occlusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Retinal Detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Retinal Ischaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Rhegmatogenous Retinal Detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Ulcerative Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Vitreous Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Vitreous Opacities SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea Haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Faeces Pale SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Large Intestine Polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Umbilical Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Generalised Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Implant site injury SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Polyp SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Sudden Cardiac Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Systemic Inflammatory Response Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Bile Duct Stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
COVID-19 Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pyelonephritis Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vascular Device Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Ankle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Burns Second Degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Facial Bones Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fibula Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fractured Sacrum SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Joint Dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Stoma Site Extravasation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Traumatic Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Blood Creatine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Intraocular Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Fluid Overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Metabolic Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Amyloid Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Foot Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Groin Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Lumbar Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Rotator Cuff Syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Benign Renal Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Bladder Cancer Recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrioventricular Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrioventricular Block Complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infected Skin Ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infusion Site Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lower Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Lumbar Vertebral Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Rib Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Bone Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Brain Cancer Metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Gastric Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Hypopharyngeal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Intraductal Proliferative Breast Lesion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Invasive Ductal Breast Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Metastases to Lymph Nodes SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Metastases to Meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Metastatic Malignant Melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Myelodysplastic Syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo Positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Conjunctival Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Visual Impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Peripheral Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infected Skin Ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Foot Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Post-traumatic Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Skin Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Thermal Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Traumatic Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
N-terminal Prohormone Brain Natriuretic Peptide Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Vitamin D Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Benign Prostatic Hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View