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 @ 1:38 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT03330795
Description: None
Frequency Threshold: 0
Time Frame: Average of approximately 25 months
Study: NCT03330795
Study Brief: Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BOLT-BMT Protocol Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device. CD3/CD19 neg allogeneic BMT: Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion. 4 None 5 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute graft versus host disease in intestine SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v20.10 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Bone marrow disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Bronchial haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Fluid balance positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Fungal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Lower urinary tract symptoms SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Meningitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v20.10 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Otitis externa SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v20.10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Respiratory failure SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Septic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Small intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Abnormal loss of weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Acid base balance abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Acute graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v20.10 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Acute lung injury SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Administration related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Appetite disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Ascites SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v20.10 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Aspergillus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood count abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Blood electrolytes decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood electrolytes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood immunoglobulin A decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood immunoglobulin G decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood magnesium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood parathyroid hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Bloody discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Body tinea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Bone disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Cardiovascular symptom SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Cerebrovascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Chest discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Chest X-ray abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Compression fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v20.10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Cutaneous symptom SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
Diaphragm muscle weakness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v20.10 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v20.10 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Endocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Enterovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Enzyme level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Epstein-Barr viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Eustachian tube disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v20.10 View
Excessive granulation tissue SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Fluid balance negative SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Fluid balance positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Flushing SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Gamma-glutamyltransferase decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v20.10 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Hyperammonaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v20.10 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hyperchloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v20.10 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v20.10 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Liver function test decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Malabsorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Medical device site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v20.10 View
Metabolic alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Monocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Monocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Mycobacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Nasal disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Nodular regenerative hyperplasia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v20.10 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Nonspecific reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Oedema genital SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v20.10 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Oedema peripheral SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Otitis externa SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v20.10 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Petechiae SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pigmentation disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Pleural disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Postoperative delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
Postoperative thoracic procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v20.10 View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v20.10 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Protein-losing gastroenteropathy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Protein urine SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Pulmonary function test decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v20.10 View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Reticulocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Right ventricular systolic pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v20.10 View
Sinus disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Skin abrasion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Skin bacterial infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Skin discomfort SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v20.10 View
Sputum culture positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v20.10 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v20.10 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Temperature regulation disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.10 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v20.10 View
Ultrasound liver abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Ultrasound scan abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Urinary casts present SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.10 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Weight loss diet SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA v20.10 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Abnormal faeces SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Aspergillus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hyperprothrombinaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v20.10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v20.10 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View
Investigation abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v20.10 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v20.10 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v20.10 View
Muscle injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.10 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v20.10 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v20.10 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v20.10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v20.10 View