Study: NCT03120949

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1043 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1043 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1043 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1043 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1043 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1043 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Bullous erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Joint abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Ludwig angina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Renal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Salpingo-oophoritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Scrotal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Wound infection pseudomonas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1043 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1043 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Muscle contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1043 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1043 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1043 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1043 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1043 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1043 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1043 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1043 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Abdominal hernia obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Benign neoplasm of thyroid gland
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Cervix carcinoma stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Clear cell renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Lung adenocarcinoma stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Meningioma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Salivary gland cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1043 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1043 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1043 at risk

Adverse event: Carotid artery aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Pineal gland cyst
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1043 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 1043 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1043 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1043 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1043 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Lithiasis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1043 at risk

Adverse event: Genital haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Dermatitis contact
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1043 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1043 at risk

Adverse event: Vestibular disorder
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1043 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 1043 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 1043 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 1043 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 95 affected / 1043 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 52 affected / 1043 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 1043 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 1043 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 1043 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 1043 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 32 affected / 1043 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1061 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1061 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1061 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1061 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1061 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1061 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Abscess soft tissue
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Bartholinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Bursitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Cat scratch disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Encephalomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Latent tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Medical device site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Necrotising soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1061 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1061 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Joint ankylosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1061 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1061 at risk

Adverse event: Acetabulum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Comminuted fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Traumatic intracranial haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1061 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1061 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Supraventricular tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1061 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1061 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Salivary gland calculus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Central nervous system neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Extranodal marginal zone B-cell lymphoma (MALT type)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Marginal zone lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1061 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1061 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1061 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1061 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Chylothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1061 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1061 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Hyperplastic cholecystopathy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Vascular stent occlusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Endometrial hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Female genital tract fistula
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Splenic cyst
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1061 at risk

Adverse event: Deafness neurosensory
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Ocular myasthenia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1061 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 87 affected / 1061 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 67 affected / 1061 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 1061 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 115 affected / 1061 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 63 affected / 1061 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 1061 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 1061 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 50 affected / 1061 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 1061 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 44 affected / 1061 at risk