Study: NCT01778049

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 352 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 352 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 352 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 352 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 352 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 352 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 352 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 352 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Calcinosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 354 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 354 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 354 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 354 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 354 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 354 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Nasal turbinate hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 354 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 354 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 354 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 126 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 126 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 126 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 128 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 128 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 128 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 128 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Balanoposthitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 128 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 128 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 128 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 128 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pharyngeal lesion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Dermatitis bullous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Dyshidrotic eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 112 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 112 at risk

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 112 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 112 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 112 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 112 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 112 at risk