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 @ 3:52 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT00964392
Description: None
Frequency Threshold: 0
Time Frame: Five years post-ablation
Study: NCT00964392
Study Brief: NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
More-experienced Physicians Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year. None None 41 125 78 125 View
Less-experienced Physicians Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year. None None 95 282 168 282 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Arteriospasm coronary SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac perforation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac procedure complication SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dressler's syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Presyncope SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Basedow's disease SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Gastrinoma SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Oesophageal injury SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Umbilical hernia, obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Alcohol withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Device related infection SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Traumatic brain injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Biopsy thyroid gland abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Cardiac pacemaker evaluation SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Cardiac stress test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Smear cervix abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Endometrial cancer stage I SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Hepatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Brain mass SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Alcohol abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary vein stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Upper airway obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cardiac ablation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cardiac pacemaker insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Abdominoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cancer surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Colectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cryotherapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Debridement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Implantable defibrillator replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Knee operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Obesity surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Packed red blood cell transfusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Artery dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Atrial thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac procedure complication SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Hypertrophic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Basedow's disease SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Thyroid neoplasm SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Periorbital haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Scleral haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Erosive oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Procedural nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Fungal oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Lip disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Procedural vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Tongue biting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Procedural pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Device malfunction SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Device power source issue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Drug intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Flank pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Mass SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Wound secretion SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Procedural headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Animal scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Confusion postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Incision site erythema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Limb crushing injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Median nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Nerve compression SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Post procedural haematuria SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Skeletal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Urinary retention postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood pressure abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Culture urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Echocardiogram SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Endoscopy upper gastrointestinal tract normal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Sinus rhythm SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Cervicobrachial syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Benign neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Neuroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Renal cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Agitation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Phrenic nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Acute psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Urethral haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.0 View
Testicular swelling SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary vein stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Painful respiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Cardiac ablation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cardioversion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cardiac pacemaker battery replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cataract operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Abdominal hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Cardiac pacemaker insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Carpal tunnel decompression SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Endotracheal intubation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Haemorrhoid operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
High frequency ablation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Incisional drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Meniscus operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Peripheral artery angioplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Skin neoplasm excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Arteriovenous fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View