Study: NCT01183533

Adverse event: New (recurrent) Ischemic Stroke
Serious: yes
Organ System: Nervous system disorders
Notes: New, interval ischemic stroke.
Frequency: 2 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory Failure leading to Death Etiology: withdrawal of support after patient suffered from pneumonia, sepsis and respiratory failure.
Frequency: 1 affected / 40 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Notes: Abscess at Feeding tube site, requiring surgical bedside drainage and antibiotics.
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death from sepsis and aspiration pneumonia.
Frequency: 1 affected / 40 at risk

Adverse event: Cerebral Edema, malignant
Serious: yes
Organ System: Nervous system disorders
Notes: Malignant cerebral edema requiring decompressive hemicraniectomy.
Frequency: 1 affected / 40 at risk

Adverse event: Seizures with neurological deterioration
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: leading to mechanical ventilation and traceostomy.
Frequency: 1 affected / 40 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Orolingual Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 40 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Vertigo with nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Shortness of breath (dyspnea)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Hemorrhage (bleeding from ear)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lung infiltrates (lower lobe)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: COPD (chronic obstructive pulmonary disease) Exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Neurological Worsening
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Elevated Creatinine and/or BUN
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension (uncontrolled)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Deep Venous Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Notes: left foot
Frequency: 1 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Increased ESR rate (erythrocyte segmentation)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumoperitoneum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 40 at risk

Adverse event: Increased INR (international normalized ratio)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Monocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Monocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Increased PTT (partial thromboplastin time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk