Study: NCT02040142

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 51 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)
Frequency: 1 affected / 51 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)
Frequency: 1 affected / 51 at risk

Adverse event: Aspartate Aminotransferase (AST) Increased
Serious: yes
Organ System: Investigations
Notes: Verbatim Term: AST Increase
Frequency: 17 affected / 51 at risk

Adverse event: Alanine Aminotransferase (ALT) Increased
Serious: yes
Organ System: Investigations
Notes: Verbatim Term: ALT Increase
Frequency: 14 affected / 51 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 51 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 51 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term: Hemoglobin Decreased
Frequency: 15 affected / 51 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 51 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 51 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Verbatim Term: Lymphocyte Decreased
Frequency: 18 affected / 51 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Verbatim Term: White Blood Cell Count Decreased
Frequency: 11 affected / 51 at risk

Adverse event: White blood cell count increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 51 at risk

Adverse event: Aspartate Aminotransferase (AST) Increased
Serious: no
Organ System: Investigations
Notes: Verbatim Term: AST Increase
Frequency: 24 affected / 51 at risk

Adverse event: Alanine Aminotransferase (ALT) Increased
Serious: no
Organ System: Investigations
Notes: Verbatim Term: ALT Increase
Frequency: 22 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 51 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 51 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term: Neutropenia
Frequency: 11 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term: Hemoglobin Decrease
Frequency: 35 affected / 51 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 51 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Lymphocyte Decrease
Frequency: 25 affected / 51 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Verbatim Term: White Blood Cell Count Decrease
Frequency: 19 affected / 51 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Verbatim Term: Blood Bilirubin
Frequency: 23 affected / 51 at risk