Study: NCT01900002

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 34 at risk

Adverse event: Hepatic haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypertenstion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Rectal Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Palmar-Planta Erythrodysesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 34 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: ALT increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: AST increase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk