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 @ 10:51 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT00617669
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00617669
Study Brief: A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ZD4054 + Docetaxel XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks None None 214 522 490 522 View
Placebo + Docetaxel placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks None None 203 525 483 525 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Lymphatic Obstruction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Myocardial Ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Aortic Valve Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiopulmonary Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Diastolic Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Hypertrophic Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Left Ventricular Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Adrenocortical Insufficiency Acute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Inappropriate Antidiuretic Hormone Secretion SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Scleral Disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Staphyloma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Upper Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Anal Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Colitis Ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Colonic Polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea Haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Duodenal Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Erosive Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastric Ulcer Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Inguinal Hernia Strangulated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Intestinal Infarction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Irritable Bowel Syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Large Intestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Lower Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Mouth Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Neutropenic Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Oesophagitis Ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Rectourethral Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Medical Device Complication SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Device Occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Hepatic Cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Neutropenic Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lobar Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Anal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Arthritis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Arthritis Infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bacterial Diarrhoea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Catheter Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lyme Disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Necrotising Fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Neutropenic Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Peritonitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumocystis Jiroveci Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Psoas Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pulmonary Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Staphylococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Staphylococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Subcutaneous Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Femoral Neck Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Subdural Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Cerebral Haemorrhage Traumatic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Facial Bones Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Kidney Rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Multiple Injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Postoperative Wound Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Radiation Pneumonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Stress Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Toxicity To Various Agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Wrist Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood Electrolytes Abnormal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Electrocardiogram QT Prolonged SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Type 2 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Osteonecrosis Of Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Pathological Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Malignant Melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Bladder Transitional Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Colorectal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Gastrointestinal Stromal Tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Lentigo Maligna Stage Unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Malignant Lymphoid Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Rectal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Renal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Depressed Level Of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Diabetic Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Spinal Cord Compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Subarachnoid Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Completed Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Bladder Neck Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Bladder Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Calculus Ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Calculus Urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Cystitis Noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Haemorrhage Urinary Tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Postrenal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal Colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal Tubular Necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Lung Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Acute Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Bronchitis Chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Stevens-Johnson Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Aortic Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Jugular Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Circulatory Collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Femoral Artery Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hypovolaemic Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
sThrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Cerebral Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Interstitial Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pleural Haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea Exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Nail Discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Nail Disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View