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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:42 AM
NCT ID: NCT02597933
Description: None
Frequency Threshold: 5
Time Frame: From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)
Study: NCT02597933
Study Brief: A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. 9 None 79 288 239 288 View
Nintedanib Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events. 10 None 88 288 270 288 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Immune thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Hypertrophic cardiomyopathy SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 21.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Retinal vein occlusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Rhegmatogenous retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Intestinal pseudo-obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Brain death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Polyp SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Anti-neutrophil cytoplasmic antibody positive vasculitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.1 View
Adenovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Campylobacter gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Postoperative ileus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Cell marker increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Forced vital capacity decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Drooping shoulder syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Fistula SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Systemic scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Benign mesothelioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Mesothelioma malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Nasopharyngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Sweat gland tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Carotid artery aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cerebral amyloid angiopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cerebral microhaemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cerebrovascular disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Bladder perforation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Scleroderma renal crisis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Vulvovaginal swelling SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Acute lung injury SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Painful respiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Systemic sclerosis pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Digital pitting scar SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Sclerema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Raynaud's phenomenon SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Pleuropericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Intestinal mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Polymyalgia rheumatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pulmonary arterial hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View