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 @ 8:20 PM
NCT ID: NCT00543569
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00543569
Study Brief: A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tacrolimus/MMF/Basiliximab Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. None None 41 79 79 79 View
Alefacept QW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. None None 48 77 77 77 View
Alefacept QW/Tacrolimus Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. None None 40 75 75 75 View
Alefacept QOW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. None None 45 78 78 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cytomegalovirus Viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Escherichia Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Polyomavirus-Associated Nephropathy SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection Enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cytomegalovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia Cytomegaloviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Arteriovenous Graft Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Bacterial Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
BK Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Bronchopulmonary Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Catheter Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Catheter Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cellulitis Enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cellulitis Of Male External Genital Organ SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cellulitis Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cervicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Clostridial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cytomegalovirus Gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Disseminated Cryptococcosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Enterococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Epstein-Barr Viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Escherichia Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Escherichia Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Fungal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Helicobacter Gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Herpes Simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Incision Site Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Meningitis Cryptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Oesophageal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Perinephric Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Peritonitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia Herpes Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia Mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia Pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pyelonephritis Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Retroperitoneal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sepsis Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Skin Bacterial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Streptococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Streptococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Ureteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Wound Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Complications Of Transplanted Kidney SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Therapeutic Agent Toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Renal Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Post Procedural Urine Leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Abdominal Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Graft Thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Incision Site Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Renal Lymphocele SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Transplant Failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Fluid Overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Retroperitoneal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal Haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Colitis Ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastrointestinal Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Haemorrhoidal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Reflux Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Vein Thrombosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Ureteric Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Focal Glomerulosclerosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Tubular Necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Nephritis Interstitial SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Obstructive Uropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Artery Stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Artery Thrombosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Mass SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Vasculitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Tubulointerstitial Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Histology Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Immunosuppressant Drug Level Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Liver Function Test Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Oxygen Saturation Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Urine Output Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
White Blood Cell Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Lymphocele SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Aortic Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Peripheral Artery Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Renovascular Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Subclavian Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Vascular Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Myocardial Ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Sick Sinus Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Haemolytic Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Lymphadenopathy Mediastinal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Obstructive Airways Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Muscle Haemorrhage 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
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Metastatic Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Multiple Myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Papillary Thyroid Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Renal Cell Carcinoma Stage Unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Thyroid Adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Anoxic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Diabetic Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Syncope Vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Unresponsive To Stimuli SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Removal Of Renal Transplant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Arteriovenous Fistula Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Nephrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Pancreas Transplant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Benign Prostatic Hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Haemorrhagic Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Atrial Septal Defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 10.0 View
Parathyroid Gland Enlargement SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
Serum Sickness SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View
Staphylococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Escherichia Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Intertrigo Candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection Pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Perirenal Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Urinary Anastomotic Leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Erosive Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Splenic Infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chronic Lymphocytic Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Mental Status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Bile Duct Stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Polycythaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal Pain Lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Catheter Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Generalised Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Impaired Healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
BK Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Candiduria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cytomegalovirus Viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Escherichia Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary Tract Infection Enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Complications Of Transplanted Kidney SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Incision Site Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Incision Site Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Perinephric Collection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Post Procedural Discharge SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Procedural Nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Therapeutic Agent Toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Wound Secretion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Blood Magnesium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Blood Urea Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
CD4 Lymphocytes Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Gamma-Glutamyltransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Immunosuppressant Drug Level Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Liver Function Test Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Urine Output Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Vitamin D Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
White Blood Cell Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Fluid Overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Fluid Retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Metabolic Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Vitamin D Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Flank 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
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Osteopenia 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
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Bladder Spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal Tubular Necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Benign Prostatic Hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Erectile Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Scrotal Oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea 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
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Skin Ulcer 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
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View