Study: NCT01147016

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 1 at risk

Adverse event: chills/rigors
Serious: no
Organ System: General disorders
Notes: grade 1 1 grade 2 5 grade 31
Frequency: 7 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 5 Grade 2 1
Frequency: 7 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 3 Grade 2 1
Frequency: 4 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 4 Grade 2 3
Frequency: 7 affected / 8 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: Grade 1 3
Frequency: 3 affected / 8 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Grade 1 1 Grade 2 1
Frequency: 2 affected / 8 at risk

Adverse event: neuroppathy
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 1 Grade 2 1 Grade 3 1
Frequency: 3 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Grade 2 5
Frequency: 5 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: grade 1 4 Grade 2 2
Frequency: 6 affected / 8 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: General disorders
Notes: Grade 1 1
Frequency: 1 affected / 8 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Grade 1 2
Frequency: 2 affected / 8 at risk

Adverse event: Neutropenia
Serious: no
Organ System: General disorders
Notes: Grade 1 1 Grade 2 1 Grade 3 1 Grade 4 1
Frequency: 4 affected / 8 at risk

Adverse event: AST elevation
Serious: no
Organ System: General disorders
Notes: grade 1 1
Frequency: 1 affected / 8 at risk

Adverse event: ALT elevation
Serious: no
Organ System: General disorders
Notes: Grade 1 1
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 4 Grade 2 1
Frequency: 5 affected / 8 at risk

Adverse event: Afibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2 1
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 1
Frequency: 1 affected / 8 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 1 2 Grade 2 1
Frequency: 3 affected / 8 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 3 Grade 2 2
Frequency: 5 affected / 8 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 1 Grade 2 1
Frequency: 2 affected / 8 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 1 Grade 2 1
Frequency: 2 affected / 8 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 2 Grade 2 1
Frequency: 2 affected / 8 at risk

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 1
Frequency: 1 affected / 8 at risk