Study: NCT00809146

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 49 affected / 514 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 514 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 33 affected / 514 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 514 at risk

Adverse event: Sepsis/SIRS/organ failure
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 514 at risk

Adverse event: Pneumonia/ Aspiration pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 514 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 514 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 514 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 514 at risk

Adverse event: Alcohol/Drug withdrawal syndrome
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 514 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 514 at risk

Adverse event: Renal failure, acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 514 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 514 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 514 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 514 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 514 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 514 at risk

Adverse event: Intracranial mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 514 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 514 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 514 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 514 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 514 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 514 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 514 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 514 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 514 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 514 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 514 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 514 at risk

Adverse event: Transfusion reaction
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 514 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Pseudoseizures
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 514 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 514 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 514 at risk

Adverse event: Vomiting/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 514 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 514 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 45 affected / 509 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 509 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 39 affected / 509 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 509 at risk

Adverse event: Sepsis/SIRS/organ failure
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 509 at risk

Adverse event: Pneumonia/ Aspiration pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 509 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 509 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 509 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 509 at risk

Adverse event: Alcohol/Drug withdrawal syndrome
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 509 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 509 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 509 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 509 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 509 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 509 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 509 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 509 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 509 at risk

Adverse event: Intracranial mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 509 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 509 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 509 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 509 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 509 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 509 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 509 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 509 at risk

Adverse event: Post-extubation stridor/airway obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 509 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 509 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 509 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 509 at risk

Adverse event: Toxic epidermal necrolysis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 509 at risk

Adverse event: Vomiting/Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 509 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 509 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 509 at risk

Adverse event: Vomiting/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 509 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 509 at risk