Study: NCT02047344

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial fibrillation Cardiac arrest Tachycardia
Frequency: 2 affected / 31 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Diarrhoea Intestinal obstruction
Frequency: 2 affected / 31 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Notes: Death Disease progression
Frequency: 2 affected / 31 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia Pyelonephritis acute
Frequency: 4 affected / 31 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Dehydration Hyponatraemia
Frequency: 2 affected / 31 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant neoplasm progression Metastases to central nervous system
Frequency: 3 affected / 31 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 1 affected / 31 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Haematuria Hydronephrosis Ureteric stenosis Urinoma
Frequency: 2 affected / 31 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute respiratory failure Dyspnoea Pulmonary oedema Respiratory distress
Frequency: 5 affected / 31 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain Abdominal pain upper Diarrhoea Flatulence Nausea Vomiting
Frequency: 30 affected / 31 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Catheter site pain Chest pain Fatigue Influenza like illness
Frequency: 20 affected / 31 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Pneumonia
Frequency: 6 affected / 31 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Urine analysis abnormal Weight decreased
Frequency: 6 affected / 31 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite Dehydration Hypomagnesaemia
Frequency: 11 affected / 31 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal pain Pain in extremity
Frequency: 8 affected / 31 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant neoplasm progression
Frequency: 4 affected / 31 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness Headache Neuropathy peripheral
Frequency: 11 affected / 31 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Insomnia
Frequency: 4 affected / 31 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Haematuria
Frequency: 4 affected / 31 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute respiratory failure Cough Dyspnoea Nasal congestion Pleural effusion Pneumothorax
Frequency: 17 affected / 31 at risk