Study: NCT01885559

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 242 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 242 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 242 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 242 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 242 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 242 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 242 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 242 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 242 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 242 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 242 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Flatulence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 242 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 242 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 242 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 242 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 242 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 242 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 242 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 242 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 242 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 242 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 242 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 242 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 242 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 242 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 242 at risk

Adverse event: Post procedural urine leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 242 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 242 at risk

Adverse event: Glucose tolerance impaired
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 242 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 242 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 242 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 242 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)
Frequency: 3 affected / 242 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 242 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 242 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pregnancy, puerperium and perinatal conditions - Other, specify
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 242 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 242 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 242 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 242 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 242 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 242 at risk

Adverse event: Renal haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 242 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 242 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 242 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 242 at risk

Adverse event: Reproductive system and breast disorders - Other, specify
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 242 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pelvic floor muscle weakness
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 242 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 242 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 242 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 242 at risk

Adverse event: Vascular disorders - Other, specify
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 242 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 242 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 242 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 244 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 244 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 244 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Endocrine disorders - Other, specify
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 244 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 244 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 244 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Arterial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Renal procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 244 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 244 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)
Frequency: 7 affected / 244 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 244 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pregnancy, puerperium and perinatal conditions - Other, specify
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 244 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 244 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 244 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Renal haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 244 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 244 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 244 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 244 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 244 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 244 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 244 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 244 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 46 affected / 244 at risk