Study: NCT02151448

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Eye disorders - Other, specify
Serious: yes
Organ System: Eye disorders
Notes: Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Not Attributed to Study Treatment
Frequency: 1 affected / 64 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Attributed to Study Treatment
Frequency: 2 affected / 64 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Attributed to Study Treatment
Frequency: 2 affected / 64 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 2 affected / 64 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 3 affected / 64 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Not Attributed to Study Treatment
Frequency: 3 affected / 64 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not Attributed to Study Treatment
Frequency: 4 affected / 64 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Notes: Not Attributed to Study Treatment
Frequency: 4 affected / 64 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 64 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 64 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 64 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 64 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 64 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 64 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 64 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 64 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Frequency: 8 affected / 64 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 64 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 64 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 64 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 64 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 64 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 64 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 64 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 64 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 64 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 64 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 64 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 64 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 36 affected / 64 at risk