Study: NCT01576341

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 3 affected / 416 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Carditis
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 5 affected / 416 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Adrenal mass
Serious: yes
Organ System: Endocrine disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Hyperparathyroidism secondary
Serious: yes
Organ System: Endocrine disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Haemorrhagic erosive gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Small intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Calcinosis
Serious: yes
Organ System: General disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Acute hepatitis B
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Carbuncle
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 5 affected / 416 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 5 affected / 416 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Shunt occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cerebral haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Glioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: † A
Frequency: 3 affected / 416 at risk

Adverse event: Extrapyramidal disorder
Serious: yes
Organ System: Nervous system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Haemorrhagic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Uraemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Renal cyst
Serious: yes
Organ System: Renal and urinary disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Notes: † A
Frequency: 20 affected / 416 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Idiopathic pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: † A
Frequency: 5 affected / 416 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Notes: † A
Frequency: 2 affected / 416 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Notes: † A
Frequency: 1 affected / 416 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: † A
Frequency: 9 affected / 416 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: † A
Frequency: 9 affected / 416 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: † A
Frequency: 13 affected / 416 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: † A
Frequency: 10 affected / 416 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: † A
Frequency: 9 affected / 416 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: † A
Frequency: 19 affected / 416 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Notes: † A
Frequency: 39 affected / 416 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: † A
Frequency: 42 affected / 416 at risk