Study: NCT00724867

Adverse event: Any event
Serious: yes
Organ System: Infections and infestations
Frequency: 44 affected / 268 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 268 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 268 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 268 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 268 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 268 at risk

Adverse event: Bacterial pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 268 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 268 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 268 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 268 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Cellulitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Fungal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Genital herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Infected dermal cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Perinephric abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Pharyngitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Streptococcal urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Sweat gland infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 268 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 268 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 268 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 268 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 268 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 268 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 268 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 268 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Fracture nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Pain in jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 268 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 268 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 268 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 268 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 268 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 268 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 268 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 268 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Oesophageal spasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Oesophageal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 268 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 268 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 268 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 268 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Comminuted fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Pneumothorax traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 268 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 268 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 268 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 268 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 268 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 268 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 268 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 268 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 / 268 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Hormone receptor positive breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Ovarian cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Thyroid adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 268 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 268 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 268 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 268 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Jugular vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Lupus vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Raynaud's phenomenon
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Subgaleal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 268 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 268 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 268 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 268 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 268 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 268 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 268 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 268 at risk

Adverse event: Persistent depressive disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 268 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 268 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 268 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 268 at risk

Adverse event: Lupus nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 268 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 268 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hypertonic bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 268 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 268 at risk

Adverse event: Anaemia of chronic disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 268 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 268 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 268 at risk

Adverse event: Uterovaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 268 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 268 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 268 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 268 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 268 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Systemic lupus erythematosus rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hereditary ataxia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 268 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 268 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 268 at risk

Adverse event: Influenza A virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 268 at risk

Adverse event: Influenza B virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 268 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 268 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Infections and infestations
Frequency: 243 affected / 268 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 268 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 268 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 268 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 268 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 268 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 268 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 268 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 268 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 268 at risk

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 268 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 268 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 268 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 268 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 268 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 268 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 268 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 268 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 217 affected / 268 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 106 affected / 268 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 268 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 268 at risk

Adverse event: SLE arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 268 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 268 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 268 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 268 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 268 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 268 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 268 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 268 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 268 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 268 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 191 affected / 268 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 268 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 268 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 268 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 268 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 268 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 268 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 268 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 268 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 268 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 163 affected / 268 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 268 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 268 at risk

Adverse event: Systemic lupus erythematosus rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 268 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 268 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 268 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 268 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Nervous system disorders
Frequency: 162 affected / 268 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 268 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 268 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 268 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 268 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 155 affected / 268 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 44 affected / 268 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 268 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 268 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 268 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 268 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 268 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 154 affected / 268 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 268 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 268 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 268 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 268 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 268 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 268 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: General disorders
Frequency: 151 affected / 268 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 60 affected / 268 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 268 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 31 affected / 268 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 30 affected / 268 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 268 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Psychiatric disorders
Frequency: 107 affected / 268 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 57 affected / 268 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 42 affected / 268 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 89 affected / 268 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 268 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Investigations
Frequency: 86 affected / 268 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Vascular disorders
Frequency: 85 affected / 268 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 44 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Eye disorders
Frequency: 79 affected / 268 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Cardiac disorders
Frequency: 56 affected / 268 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Immune system disorders
Frequency: 53 affected / 268 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 29 affected / 268 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 17 affected / 268 at risk

Adverse event: Any event
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 37 affected / 268 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 268 at risk

Adverse event: Sinusitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 268 at risk