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: 2025-12-25 @ 1:11 AM
Ignite Modification Date: 2025-12-25 @ 11:21 PM
NCT ID: NCT03834493
Description: All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received.
Frequency Threshold: 5
Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022)
Study: NCT03834493
Study Brief: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo + Enzalutamide Participants received placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression. 291 None 165 620 551 620 View
Pembrolizumab + Enzalutamide Second Course Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional) plus enzalutamide. 1 None 0 4 0 4 View
Pembrolizumab + Enzalutamide Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression. 295 None 238 615 563 615 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acquired factor VIII deficiency SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Normochromic normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Acute left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Phimosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 25.1 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
Inappropriate antidiuretic hormone secretion SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
Primary adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
Blindness unilateral SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Autoimmune colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Immune-mediated enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Immune-mediated gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Large intestinal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Oesophageal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Hepatitis cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Immune-mediated hepatic disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.1 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Cytomegalovirus gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Device related bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Fournier's gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Infected fistula SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pharyngeal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Spinal cord infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Suspected COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Postpolypectomy syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Spinal column injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Vitamin K deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Bone lesion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Osteonecrosis of jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Osteoporotic fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Polyarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Polymyalgia rheumatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Bile duct cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Bladder neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Central nervous system neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Gastrointestinal stromal tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Hepatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Oropharyngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Prostate cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Squamous cell carcinoma of the oral cavity SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
T-cell prolymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Malignant spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Mononeuropathy multiplex SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Monoparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Quadriparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Thrombotic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Immune-mediated nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Immune-mediated renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Postrenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Ureteric stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Urethral obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Pulmonary sarcoidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Dermatitis exfoliative generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Toxic skin eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Euthanasia SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View