Study: NCT00615108

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3148 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Dizziness, Dizzling
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3148 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Ileal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3148 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3148 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3148 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3148 at risk