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 @ 11:05 PM
Ignite Modification Date: 2025-12-25 @ 8:36 PM
NCT ID: NCT04447469
Description: None
Frequency Threshold: 0
Time Frame: From enrollment (all-cause mortality) or first dose of study drug (adverse events) to the end of study; the maximum study duration was 44 weeks.
Study: NCT04447469
Study Brief: Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 2: Placebo (Cohort 1) Non-mechanically ventilated participants administered placebo as a single IV infusion 9 None 13 40 23 40 View
Phase 2: 10 mg/kg (Cohort 1) Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion 4 None 5 35 19 35 View
Phase 2: 6 mg/kg (Cohort 1) Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion 5 None 7 41 18 41 View
Phase 2: 10 mg/kg (Cohort 2) Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion 7 None 10 15 11 15 View
Phase 2: 6 mg/kg (Cohort 2) Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion 9 None 12 15 12 15 View
Phase 2: Placebo (Cohort 2) Mechanically ventilated participants administered placebo as a single IV infusion 9 None 10 17 14 17 View
Phase 3: 10 mg/kg (Cohort 1) Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion 20 None 48 195 90 195 View
Phase 3: 6 mg/kg (Cohort 1) Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion 30 None 49 188 86 188 View
Phase 3: Placebo (Cohort 1) Non-mechanically ventilated participants administered placebo as a single IV infusion 30 None 43 191 83 191 View
Phase 3: 10 mg/kg (Cohort 2) Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion 7 None 13 20 12 20 View
Phase 3: 6 mg/kg (Cohort 2) Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion 8 None 14 21 13 21 View
Phase 3: Placebo (Cohort 2) Mechanically ventilated participants administered placebo as a single IV infusion 12 None 15 20 17 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Leukaemoid reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiovascular insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Pituitary apoplexy SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Mydriasis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Incarcerated inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Brain death SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Medical device site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Candida pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Enterobacter pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Enterobacter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Klebsiella sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia acinetobacter SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Serratia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Severe acute respiratory syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheobronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hairy cell leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Brain injury SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Brain stem stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues MedDRA 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urethral haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory tract haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Haemodynamic instability SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Lip blister SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Swollen tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Infusion site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Allergy to vaccine SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Type I hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Acinetobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Acinetobacter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Burkholderia cepacia complex infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Candida pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Epstein-Barr virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Haemophilus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes ophthalmic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infected skin ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Relapsing fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory moniliasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sedation complication SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Stenotrophomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Systemic mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheobronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Eschar SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Mechanical ventilation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Penis injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Procedural site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Tooth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood fibrinogen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Body temperature decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Electrocardiogram change SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Gram stain positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Lymphocyte morphology abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Mean arterial pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Myocardial necrosis marker increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
N-terminal prohormone brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Proteus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Pulse pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Sputum culture positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Strongyloides test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Urine analysis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Alkalosis hypochloraemic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Diabetic metabolic decompensation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperchloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperinsulinaemic hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Metabolic alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Vitamin B12 deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Plantar fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Soft tissue mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Allodynia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Anosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Autonomic nervous system imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hypokinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Intensive care unit acquired weakness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Meige's syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Psychomotor hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Quadriparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Toxic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Generalised anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Intensive care unit delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Bladder dilatation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Balanoposthitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Apnoeic attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Choking SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Diaphragmatic paralysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory tract haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Tracheomalacia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Scab SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Blood pressure fluctuation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Embolism venous SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Essential hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Microangiopathy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Phlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Subclavian vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Venous haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Normochromic normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cor pulmonale SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Familial tremor SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 23.0 View
Cerumen impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Ear congestion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Diabetes insipidus SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Parathyroid disorder SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Presbyopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chapped lips SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Methaemoglobinaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Hypocoagulable state SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View