Study: NCT01824693

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 6 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 6 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 6 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal 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: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 9 at risk

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

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

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

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

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

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

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

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

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk