Study: NCT01022138

Adverse event: Ascites
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cardiac General
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Musculoskeletal/Soft Tissue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Ascites
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 30 affected / 42 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 31 affected / 42 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 22 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 14 affected / 42 at risk

Adverse event: Hypoxia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Metabolic/Laboratory
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 20 affected / 42 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 42 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 11 affected / 42 at risk