Study: NCT00859014

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Not Study Related
Frequency: 2 affected / 25 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Stroke Expansion
Serious: yes
Organ System: Nervous system disorders
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Not Study Related
Frequency: 2 affected / 25 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Not Study Related
Frequency: 2 affected / 25 at risk

Adverse event: Carotid Hyperperfusion Syndrome
Serious: yes
Organ System: Nervous system disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Primary Non Small Cell Lung Carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Fracture Lumbar Vertebra
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: General disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Hospital admission for observation
Serious: yes
Organ System: General disorders
Notes: Not Study Related
Frequency: 1 affected / 25 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not Study Related
Frequency: 5 affected / 25 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-specific Musculoskeletal Pain
Frequency: 9 affected / 25 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not Study Related
Frequency: 2 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Not Study Related
Frequency: 2 affected / 25 at risk

Adverse event: Vomitting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Culture Bottle Skin Contamination, Suspected
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Study Related. All occurred greater than 4 months after enrollment
Frequency: 3 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Nine patients were foley catheter associated. Remaining (one) experienced symptoms prior to infusion
Frequency: 10 affected / 25 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Not Study Related
Frequency: 2 affected / 25 at risk

Adverse event: Prolonged Partial Thromboplastin Time
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Increased Alanine Aminotransferase
Serious: no
Organ System: Investigations
Notes: All events are grade 1. All patients were on statins. Three patients had transient increase within 30 days and resolved. Three patients continued to fluctuate beyond 30 days. Two patients had normal ALT up till 30 days and later had elevation
Frequency: 7 affected / 25 at risk

Adverse event: Increased Aspartate Aminotransferase
Serious: no
Organ System: Investigations
Notes: All events are grade 1. All patients were on statins. Five patients had transient increase within 30 days and resolved. Two patients continued to fluctuate beyond 30 days. Four patients had normal AST up till 30 days and later had elevation
Frequency: 11 affected / 25 at risk

Adverse event: Increased INR
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 5 affected / 25 at risk

Adverse event: Increased Lipase
Serious: no
Organ System: Investigations
Notes: Adjudicated as statin related
Frequency: 2 affected / 25 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 6 affected / 25 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 4 affected / 25 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 7 affected / 25 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 4 affected / 25 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Not Study Related
Frequency: 2 affected / 25 at risk

Adverse event: Hemorrhagic Transformation of Ischemic Stroke
Serious: no
Organ System: Nervous system disorders
Notes: All events are grade 1 and were asymptomatic.
Frequency: 7 affected / 25 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Nervous system disorders
Notes: All events are grade 1, were asymptomatic, and were not study related.
Frequency: 2 affected / 25 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Study Related
Frequency: 5 affected / 25 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: General disorders
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Not Study Related
Frequency: 3 affected / 25 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Four events were not study related. Remaining (one) was relative hypotension.
Frequency: 5 affected / 25 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Six Not Study Related. All events grade 1 and 2
Frequency: 14 affected / 25 at risk