Study: NCT01197521

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Reflux gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 310 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 310 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 310 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 310 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 310 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 310 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: Pancreatitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 310 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 310 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 310 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 310 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 310 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 310 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 310 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 310 at risk

Adverse event: Haemorrhagic ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 310 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 310 at risk

Adverse event: Vitiligo
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 310 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 310 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 310 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 310 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 310 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 310 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 310 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 310 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 310 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 310 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 310 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 310 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 310 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 59 affected / 310 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 304 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Atrial thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Bacterial diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 304 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Ganglioneuroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 304 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 304 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 304 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 304 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 304 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 304 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 304 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 304 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 304 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 304 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 304 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 58 affected / 304 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chorioretinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 304 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 304 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 304 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 304 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 304 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 304 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 304 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 304 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 304 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 304 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 304 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 304 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 304 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 304 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 304 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 304 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 304 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 304 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 304 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 304 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 304 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 304 at risk