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 @ 2:43 PM
Ignite Modification Date: 2025-12-25 @ 1:13 PM
NCT ID: NCT00330759
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: up to 2 years 9 months
Study: NCT00330759
Study Brief: Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zoledronic Acid 4 mg Q4W None None None 581 878 767 878 View
Denosumab 120 mg Q4W None None None 552 878 751 878 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Anaemia of chronic disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Aplastic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Erythropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Hyperviscosity syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Retroperitoneal lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardio-respiratory distress SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Congestive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Intracardiac thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Paroxysmal arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Retinal vein occlusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Aphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Caecitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Enterocolitis haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastrointestinal hypomotility SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Intra-abdominal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Mechanical ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Neutropenic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Oesophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Sigmoiditis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Adverse event SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Catheter related complication SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Euthanasia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Hyperpyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Inflammation of wound SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Suprapubic pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hepatorenal failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hepatorenal syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Abdominal wall infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Brain abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cavernous sinus thrombosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastritis fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Infected skin ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Neutropenic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Osteomyelitis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumocystis jiroveci pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pulmonary mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Purulent discharge SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pyothorax SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Rectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Salmonellosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Collapse of lung SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Drug toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Fractured ischium SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Fractured sacrum SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Ilium fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Jaw fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Lung injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Post procedural discharge SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Radiation oesophagitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Splenic rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Stent-graft endoleak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Therapeutic agent toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Traumatic brain injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood creatinine abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood potassium SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Monoclonal immunoglobulin present SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Sputum abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Marasmus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Coccydynia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Joint crepitation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Osteitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Polyarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Bile duct cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Cervix cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Hepatic cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Malignant ascites SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Malignant pleural effusion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to abdominal cavity SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to bone marrow SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to gastrointestinal tract SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to lymph nodes SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to peritoneum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to pleura SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to rectum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastases to spine SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastasis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastatic bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastatic carcinoma of the bladder SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastatic pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Metastatic renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Multiple myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Non-small cell lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Paraneoplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Pericardial effusion malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Pharyngeal neoplasm benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Rectal cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Sarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Small cell lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Tumour associated fever SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Tumour thrombosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Altered state of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Apraxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cauda equina syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebral artery embolism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cervical cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cervical root pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Coma uraemic SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Diplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Epiduritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Facial palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Facial paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hemiplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Mental impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Monoparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Monoplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Motor dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Nerve root compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Polyneuropathy alcoholic SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Psychomotor skills impaired SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Sensory disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Sensory loss SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Emotional distress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Psychotic disorder due to a general medical condition SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Bladder mass SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Bladder obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Nephroangiosclerosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Urethral obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Urinary bladder haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Urinary tract disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Orchitis noninfective SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Bronchial obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dyspnoea at rest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Hydropneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Oesophagobronchial fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pharyngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Respiratory tract haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Tracheal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Lichenoid keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Immobile SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 12.0 View
Abdominal wall operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Medical device removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Aortic occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Arterial thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Arteritis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Peripheral artery aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Subclavian vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Superior vena caval occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View