Study: NCT01959672

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: 2 grade 3
Frequency: 2 affected / 11 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Notes: 3 grade 3 and 3 grade 4
Frequency: 6 affected / 11 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Notes: 4 grade 3
Frequency: 4 affected / 11 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Notes: 4 grade 3
Frequency: 4 affected / 11 at risk

Adverse event: Reduced ANC
Serious: yes
Organ System: Investigations
Notes: 2 grade 3 and 4 grade 4
Frequency: 2 affected / 11 at risk

Adverse event: Nausea
Serious: yes
Organ System: Investigations
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Investigations
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Depression
Serious: yes
Organ System: Investigations
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Renal and urinary disorders
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Infections and infestations
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: ALT elevation
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 2 grade 3
Frequency: 2 affected / 11 at risk

Adverse event: AST elevation
Serious: yes
Organ System: Vascular disorders
Notes: 1 grade 3 and 1 grade 4
Frequency: 2 affected / 11 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Investigations
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Vascular disorders
Notes: 1 grade 4
Frequency: 1 affected / 11 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 4
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 1 grade 4
Frequency: 1 affected / 11 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Nervous system disorders
Notes: 1 grade 4
Frequency: 1 affected / 11 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Cardiac disorders
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 grade 3
Frequency: 1 affected / 11 at risk

Adverse event: Orthostasis
Serious: no
Organ System: Investigations
Notes: 1 grade 1-2
Frequency: 1 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Notes: 1 grade 1-2
Frequency: 1 affected / 11 at risk