Study: NCT02939651

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Polymyaglia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Elevated ALT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Elevated ALK
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Upper GI bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 21 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 21 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 21 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk