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: 2025-12-25 @ 2:33 AM
Ignite Modification Date: 2025-12-26 @ 1:09 AM
NCT ID: NCT02452034
Description: All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Frequency Threshold: 0
Time Frame: AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110.
Study: NCT02452034
Study Brief: Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3.5 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. 1 None 3 14 13 14 View
4.5 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. 0 None 4 15 15 15 View
4.5 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. 0 None 5 16 16 16 View
6.0 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. 2 None 8 29 29 29 View
3.5 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. 0 None 8 21 20 21 View
6.0 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received POS at 6 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. 1 None 3 20 19 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Hepatic lesion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Venoocclusive liver disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Adenovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Enterobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Systemic mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Chest wall haematoma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Venoocclusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Engraftment syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lip pruritus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ear haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Anal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Anorectal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Faeces hard SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Loose tooth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral mucosal blistering SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral mucosal exfoliation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Scalloped tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Tongue haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Tooth loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Catheter site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Catheter site oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Catheter site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Granuloma SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Infusion site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Engraftment syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Graft versus host disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Graft versus host disease in gastrointestinal tract SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Graft versus host disease in liver SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Immunodeficiency SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Immunodeficiency common variable SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Serum sickness SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Adenovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Enterobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Epstein-Barr virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hepatitis E SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Human bocavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Klebsiella bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia parainfluenzae viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Proctitis herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Allergic transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Buttock injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
BK polyomavirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Bacterial test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood culture positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood immunoglobulin G decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood uric acid decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Cytomegalovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Drug level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Fluid balance positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Pulmonary arterial pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Viral test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Vitamin D decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Fluid intake reduced SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Magnesium deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Soft tissue swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Intention tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Opisthotonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Glycosuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Perineal erythema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Perineal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Scrotal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Testicular oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Vulvovaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Increased viscosity of bronchial secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pharyngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Tonsillar exudate SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Macule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hyperaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Venoocclusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View