Study: NCT02420717

Adverse event: Blood and Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Blood antidiuretic hormone abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood Bilirubin Increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Eye Disorders - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 5 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain Extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Psychiatric Disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infection and Infestations - other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Blood Bilirubin Increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infections and Infestations Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: General Disorders and Administration Site Conditions, Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infection and Infestations - other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Blood Bilirubin Increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk