Study: NCT02340585

Adverse event: Cerebral artery embolism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 298 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 298 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 298 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 298 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 298 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 298 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 298 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 298 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 298 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 298 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Diarrheic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Diverticulitis intestinal hemmorhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Gastrointestinal hemmorhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 298 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Application site haematoma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 298 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Human anaplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 298 at risk

Adverse event: Enterocolitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 298 at risk

Adverse event: Groin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 298 at risk

Adverse event: Pelvic abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 298 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 298 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 298 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 298 at risk

Adverse event: Post-procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 298 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 298 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 298 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 298 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 298 at risk

Adverse event: Vessel perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 298 at risk

Adverse event: Inappropriate antidiurectic hormone secretion
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 298 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 298 at risk

Adverse event: Muscle haemorrhage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 298 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 298 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 298 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 298 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 298 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 298 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 298 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 298 at risk

Adverse event: Gallbladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 298 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 298 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Convulsion or seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 298 at risk

Adverse event: Migraine or status migrainosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 298 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 298 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Parathesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Vertebrobasilar artery dissection
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 298 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Ruptured cerebral aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 298 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 298 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 298 at risk

Adverse event: Nephrogenic anaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 298 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 298 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 298 at risk

Adverse event: Carotid artery stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 298 at risk

Adverse event: Angioplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Intracerebral aneurysm operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 18 affected / 298 at risk

Adverse event: Colostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Peripheral artery stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 298 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 298 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 298 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 298 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 298 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 298 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 298 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 298 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 298 at risk

Adverse event: Increased tendency to bruise
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 298 at risk

Adverse event: Arrhythmia, tachycardia, afib or bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 298 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 298 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 298 at risk

Adverse event: Blurred vision, diplopia, vision impairment or reduced acuity
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 298 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 298 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 298 at risk

Adverse event: Abdominal pain or discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 298 at risk

Adverse event: Nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 298 at risk

Adverse event: Application site injury
Serious: no
Organ System: General disorders
Notes: Administration site pain, swelling, secretion, hematoma or hemmorhage
Frequency: 19 affected / 298 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 298 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 298 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 298 at risk

Adverse event: Any pain
Serious: no
Organ System: General disorders
Notes: chest, facial, application site, general
Frequency: 7 affected / 298 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 298 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 298 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 298 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 298 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 298 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 298 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 298 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 298 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 298 at risk

Adverse event: Other musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: arthalgia, groin pain, musculoskeletal pain, pain in extremity
Frequency: 13 affected / 298 at risk

Adverse event: Cerebral vasoconstriction
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 298 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 298 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 298 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 298 at risk

Adverse event: Vertebrobasilar artery dissection
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 298 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 298 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 298 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 298 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 298 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 298 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 298 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 298 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 298 at risk

Adverse event: Contusion
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 298 at risk

Adverse event: Thrombosis in device
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 298 at risk