Study: NCT00106535

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 392 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 392 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 392 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 392 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 392 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Large intestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 392 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Granulomatosis with polyangiitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 392 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 392 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 392 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 392 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 392 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 392 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 392 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 392 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 392 at risk

Adverse event: Jaw cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 392 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 392 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 392 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 392 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 392 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 392 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 392 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 392 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 392 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 392 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 392 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 392 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 392 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 392 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 392 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 392 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 392 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 392 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 392 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 392 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 392 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 392 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 392 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 392 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 392 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 392 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 392 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 392 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 392 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 392 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 392 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 599 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 599 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 599 at risk

Adverse event: Cardiac myxoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 599 at risk

Adverse event: Cervix carcinoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 599 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 599 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 599 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 599 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 599 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 599 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 599 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 599 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Bursitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 599 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Gallbladder empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Pseudomonas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 599 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Post procedural stroke
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 599 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 599 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 599 at risk

Adverse event: Cervix carcinoma stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 599 at risk

Adverse event: Lung squamous cell carcinoma stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 599 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 599 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 599 at risk

Adverse event: Metatarsalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 599 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 599 at risk

Adverse event: Mouth ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 599 at risk

Adverse event: Hypoglycaemic unconsciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 599 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 599 at risk

Adverse event: Diffuse vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 599 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 599 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 599 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 599 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 599 at risk

Adverse event: Ingrowing nail
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 599 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 599 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 599 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 599 at risk

Adverse event: Corneal perforation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 599 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 599 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 599 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 599 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 34 affected / 599 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 599 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 599 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 599 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 599 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 599 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 599 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 599 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 599 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 599 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 599 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 599 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 599 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 599 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 10 affected / 599 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 599 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 599 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 599 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 599 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 599 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 599 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 599 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 1054 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1054 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1054 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1054 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1054 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1054 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1054 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1054 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1054 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1054 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1054 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1054 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1054 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1054 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1054 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1054 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1054 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1054 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1054 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1054 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1054 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1054 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Bursitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Staphylococcal device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Tuberculous pleurisy
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1054 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Abscess soft tissue
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Appendiceal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Candida osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Coccidioidomycosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Epiglottitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: External ear cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Mycobacterium chelonae infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Pneumonia cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Prostate infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Salpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Systemic candida
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Tubo-ovarian abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1054 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1054 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1054 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1054 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Dislocation of vertebra
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Periprosthetic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Synovial rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1054 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1054 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Breast cancer stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1054 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1054 at risk

Adverse event: Lung adenocarcinoma stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1054 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1054 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Benign lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Endometrial cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 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 / 1054 at risk

Adverse event: Gastrooesophageal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Large cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Neuroendocrine carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 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 / 1054 at risk

Adverse event: Non-small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Ovarian cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Renal cell carcinoma stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Tongue cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1054 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 1054 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1054 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Muscle disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1054 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Inflammatory bowel disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pancreatic pseudocyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pancreatitis necrotising
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1054 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1054 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1054 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Cerebral atrophy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Demyelination
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Myasthenia gravis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Central nervous system vasculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1054 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1054 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Ventricular hypokinesia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1054 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Acute interstitial pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pleural fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Rheumatoid lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Arterial insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Varicophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Bicytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Hilar lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Biliary tract disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Hepatic vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1054 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1054 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Infusion site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Scleroderma renal crisis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Urinary bladder polyp
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cutaneous vasculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Palpable purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1054 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1054 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1054 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1054 at risk

Adverse event: Blood pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1054 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 256 affected / 1054 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 170 affected / 1054 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 123 affected / 1054 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 141 affected / 1054 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 135 affected / 1054 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 97 affected / 1054 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 100 affected / 1054 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 1054 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 111 affected / 1054 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 1054 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 105 affected / 1054 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 1054 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 103 affected / 1054 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 66 affected / 1054 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 1054 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 1054 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 56 affected / 1054 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 64 affected / 1054 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 1054 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 1054 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 1054 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 99 affected / 1054 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 1054 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 60 affected / 1054 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 55 affected / 1054 at risk