Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:30 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT05007392
Description: Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Frequency Threshold: 0
Time Frame: From first dose of study drug up to Week 24
Study: NCT05007392
Study Brief: A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Febuxostat Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24. 0 None 4 225 203 225 View
Dotinurad Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24. 0 None 3 223 201 223 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Glomerulonephritis membranous SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 26.0. View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Neoplasm skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 26.0. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Monocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Monocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 26.0. View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Cardiac discomfort SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Right ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 26.0. View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 26.0. View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 26.0. View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 26.0. View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 26.0. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Gingival swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Anal eczema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Duodenogastric reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Ileal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Tooth impacted SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Gastric polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 26.0. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 26.0. View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 26.0. View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 26.0. View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 26.0. View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 26.0. View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
Hepatic lesion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
Gallbladder enlargement SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
Gallbladder polyp SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 26.0. View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Carbuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Clonorchiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Tinea cruris SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0. View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Muscle injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Foreign body in eye SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Injury corneal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 26.0. View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Alpha 1 microglobulin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood uric acid decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
High density lipoprotein decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Beta 2 microglobulin urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Beta 2 microglobulin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Urine osmolarity decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Urinary occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Beta-N-acetyl-D-glucosaminidase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Albumin urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood glucose SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood triglycerides SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Bone density increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Coronavirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Electrocardiogram ST segment elevation SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Globulins increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Monocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Monocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Renal scan abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Urine albumin/creatinine ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Urine leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood creatine phosphokinase MB increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Blood glucose abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Creatinine urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Electrocardiogram P wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Electrocardiogram Q waves SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Electrocardiogram ST segment abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Electrocardiogram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Electrocardiogram repolarisation abnormality SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Globulins decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Urinary occult blood SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 26.0. View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hypouricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hyperamylasaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hyperhomocysteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0. View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Bone hypertrophy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Gouty tophus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 26.0. View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 26.0. View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 26.0. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 26.0. View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 26.0. View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 26.0. View
Dreamy state SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 26.0. View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 26.0. View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 26.0. View
Cardiovascular somatic symptom disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 26.0. View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Microalbuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Albuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Renal injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Glomerulonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Leukocyturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Renal milk of calcium cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Urate nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 26.0. View
Prostatic calcification SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 26.0. View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 26.0. View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 26.0. View
Prostatomegaly SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 26.0. View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 26.0. View
Nasal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 26.0. View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 26.0. View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 26.0. View
Reflux laryngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 26.0. View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 26.0. View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Urticaria papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 26.0. View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 26.0. View
Phlebolith SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 26.0. View