Study: NCT01031498

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death is due to disease progression and is unrelated to study drug
Frequency: 2 affected / 49 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug
Frequency: 3 affected / 49 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated to study drug
Frequency: 2 affected / 49 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Infection Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to study drug
Frequency: 1 affected / 49 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 51 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 51 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 51 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 51 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death is due to disease progression and is unrelated to study drug
Frequency: 3 affected / 50 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 50 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 50 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 50 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to study drug
Frequency: 1 affected / 50 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to study drug
Frequency: 1 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk