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 @ 11:09 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT03199469
Description: All-cause mortality and AEs included SAF population that consisted of all randomized participants who received resamirigene bilparvovec.
Frequency Threshold: 5
Time Frame: From first dose to 5 years
Study: NCT03199469
Study Brief: A Study of AT132 in Young Children With X-Linked Myotubular Myopathy (XLMTM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1.3 x 10^14 vg/kg (Low Dose) Participants received 1.3 x 10\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant. 1 None 5 7 7 7 View
3.5 x 10^14 vg/kg (High Dose) Participants received 3.5 × 10\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant. 3 None 13 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adenoidal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Epiglottic oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Withdrawal hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Combined immunodeficiency SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v26.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Protein-losing gastroenteropathy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatitis cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v26.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia parainfluenzae viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia respiratory syncytial viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Serratia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Cholesteatoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA v26.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pulmonary valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Coxsackie viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Ear infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Enterobiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Ammonia increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Bile acids increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Bilirubin urine SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood alkaline phosphatase decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Electrocardiogram ST segment elevation SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Electrocardiogram low voltage SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Faecal fat increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Haptoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Human rhinovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Interleukin level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Interleukin-2 receptor increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Transferrin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Transferrin saturation increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Troponin T increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Ultrasound liver abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Ultrasound scan abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Urine sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Feeding intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Tracheal fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Acanthosis nigricans SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Hirsutism SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Pneumonia pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Immune thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Neutrophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Coronary sinus dilatation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Left ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Right ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Tricuspid valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Dolichocephaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v26.0 View
Laryngeal cleft SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v26.0 View
Portal venous system anomaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v26.0 View
Talipes SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v26.0 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v26.0 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v26.0 View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v26.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v26.0 View
Precocious puberty SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v26.0 View
Astigmatism SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Regurgitation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Catheter site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Developmental delay SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Medical device site granuloma SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Biliary dilatation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatic cyst SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Allergic oedema SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v26.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v26.0 View
Adenovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Bacterial tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Gastrointestinal bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Gastrointestinal bacterial overgrowth SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Otitis media staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Rectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Scarlet fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Tracheostomy infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Upper respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Post procedural fever SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Stoma site hypergranulation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Aldolase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood creatine phosphokinase BB increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood creatine phosphokinase MB increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood immunoglobulin G decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood iron increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood osmolarity increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood zinc decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Carbon dioxide decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Cardiac imaging procedure abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Complement factor decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Cytokine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Echocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Lymphocyte morphology abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Myocardial necrosis marker increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Neutrophil toxic granulation present SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Pancreatic enzymes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Prealbumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Prothrombin time abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
QRS axis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Red blood cell burr cells present SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Serum ferritin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Stool reducing substances increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Thrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Vitamin A deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Epiphyses delayed fusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Epiphyses premature fusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Extremity contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Kyphosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Cholesteatoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Haemangioma of liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Language disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA v26.0 View
Device malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA v26.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Autism spectrum disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Testicular disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v26.0 View
Testicular infarction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v26.0 View
Adenoidal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Epiglottic oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Increased bronchial secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Lower respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Obstructive sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pharyngeal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pigmentation disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Tracheostomy closure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA v26.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View