Study: NCT01665768

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 49 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 49 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Skin lesions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 49 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 49 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 49 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 31 affected / 49 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 49 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 29 affected / 49 at risk

Adverse event: Pain - throat
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 49 at risk