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 @ 7:22 PM
Ignite Modification Date: 2025-12-25 @ 5:01 PM
NCT ID: NCT00838903
Description: SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Frequency Threshold: 2
Time Frame: On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.
Study: NCT00838903
Study Brief: Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Albiglutide 30 mg Plus Metformin Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. None None 44 302 242 302 View
Placebo Plus Metformin Participants received metformin \>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. None None 15 101 75 101 View
Sitagliptin 100 mg Plus Metformin Participants received sitagliptin 100 mg daily plus metformin \>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. None None 32 302 229 302 View
Glimepiride 2 mg Plus Metformin Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. None None 36 307 258 307 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hepatic cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung squamous cell carcinoma stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Oesophageal spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Post procedural cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arteriospasm coronary SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Uterine cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer stage III SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Gastrointestinal cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Device malfunction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Complicated migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Viith nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dacryostenosis acquired SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Cervical Polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Erectile Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View