Study: NCT01733628

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 135 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 135 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 135 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: ICTUS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 135 at risk

Adverse event: Skin infection: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Lynph Gland Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Penile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 135 at risk

Adverse event: Coronary Angiography
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 135 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 135 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 135 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 135 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 135 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 8 affected / 135 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 11 affected / 135 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 12 affected / 135 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 3 affected / 135 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 3 affected / 135 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 3 affected / 135 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 135 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 1 affected / 135 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 135 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Fistulized perianal abscess
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 3 affected / 135 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 2 affected / 135 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 135 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 135 at risk