Study: NCT01143064

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 596 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 596 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 596 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 596 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 596 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 38 affected / 596 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 596 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 596 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 596 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 596 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 596 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 596 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 596 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 596 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 596 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 596 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 596 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 596 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 596 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 596 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 209 affected / 596 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 94 affected / 596 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 86 affected / 596 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 59 affected / 596 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 596 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 596 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 596 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 596 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 129 affected / 596 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 71 affected / 596 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 156 affected / 596 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 596 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 596 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 51 affected / 596 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 596 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 69 affected / 596 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 79 affected / 596 at risk

Adverse event: Diabetes insipidus
Serious: no
Organ System: Endocrine disorders
Frequency: 33 affected / 596 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 583 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 583 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 583 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 583 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 583 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 40 affected / 583 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 583 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 583 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 583 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 583 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 583 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 583 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 583 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 583 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 583 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 583 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 583 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 583 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 583 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 583 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 229 affected / 583 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 126 affected / 583 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 85 affected / 583 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 64 affected / 583 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 583 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 583 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 583 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 583 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 127 affected / 583 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 80 affected / 583 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 159 affected / 583 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 583 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 102 affected / 583 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 583 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 583 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 63 affected / 583 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 78 affected / 583 at risk

Adverse event: Diabetes insipidus
Serious: no
Organ System: Endocrine disorders
Frequency: 43 affected / 583 at risk