Study: NCT01955707

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Toxic nodular goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 82 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 82 at risk

Adverse event: Urinary tract infection pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 82 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 82 at risk

Adverse event: Glioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 82 at risk

Adverse event: Basilar artery thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cerebral mass effect
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Dementia Alzheimer's type
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 82 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Neurological decompensation
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Subdural hygroma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Vocal cord paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 82 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Endarterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 82 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 82 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 82 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 82 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 82 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 82 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 82 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 82 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 82 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 82 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 82 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 82 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 82 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 82 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 82 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 82 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 82 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 82 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 82 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 82 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 82 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 82 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 82 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 82 at risk

Adverse event: Neurological decompensation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 82 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 82 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 82 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 82 at risk

Adverse event: Post stroke depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 82 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 82 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 82 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 82 at risk

Adverse event: Splenic haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 78 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 78 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Avulsion fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Cholangiocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

Adverse event: Cerebral mass effect
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 78 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Generalised onset non-motor seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Neurological decompensation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Stroke in evolution
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 78 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 78 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 78 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 78 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 78 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 78 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 78 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 78 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 78 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 78 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 78 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 78 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 78 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 78 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 78 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 78 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 78 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 78 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 78 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 78 at risk

Adverse event: Neurological decompensation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 78 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 78 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 78 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 78 at risk

Adverse event: Post stroke depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 78 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 78 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 78 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 78 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 78 at risk