Study: NCT01877668

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 107 at risk

Adverse event: Psoriatic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Infected neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Squamous cell carcinoma of the vulva
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 107 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 107 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 107 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 107 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 107 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 107 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 107 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 104 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 104 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 104 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Dermal cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 104 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 104 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 104 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 104 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 104 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 104 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 104 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 104 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 106 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Pyoderma streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 106 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Postmenopausal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 106 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 106 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 106 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 106 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 106 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 106 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 106 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 106 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 106 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 106 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 106 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 52 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 52 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 53 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 53 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 53 at risk