Study: NCT00955747

Adverse event: atrial fibrillation, cardiac chest pain, shortness of breath,
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 207 at risk

Adverse event: Pneumonia, lower respiratory infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Worsening of Lower Backache
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 207 at risk

Adverse event: Carcinoma Head of Pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 207 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 207 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 207 at risk

Adverse event: Gastrointestinal motility disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 207 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 207 at risk

Adverse event: Infrequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 207 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 207 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 207 at risk

Adverse event: Faeces hard
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 207 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 207 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 207 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 207 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 207 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 207 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 207 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 207 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 207 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 207 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 207 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 207 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 207 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 207 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 207 at risk

Adverse event: Defaecation urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 207 at risk

Adverse event: atrial fibrillation, cardiac chest pain, shortness of breath,
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 185 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 185 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 185 at risk

Adverse event: Gastrointestinal motility disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 185 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 185 at risk

Adverse event: Infrequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 185 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 185 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 185 at risk

Adverse event: Faeces hard
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 185 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 185 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 185 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 185 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 185 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 185 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 185 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 185 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 185 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 185 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 120 affected / 185 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 185 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 185 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 185 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 185 at risk

Adverse event: Defaecation urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 185 at risk