Study: NCT02037230

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

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: ALT/AST elevation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Anorexia, nausea/vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Anorexia, nausea/vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk