Study: NCT00313716

Adverse event: Brain death
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Brain tissue hypoxia
Serious: yes
Organ System: Nervous system disorders
Notes: Brain tissue pO2 less than 10 mmHg for more than 10 minutes
Frequency: 3 affected / 38 at risk

Adverse event: delayed or recurrent intracranial hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: new hematoma or increase in hematoma after initial CT scan, or recurrence of a hematoma after surgical evacuation
Frequency: 10 affected / 38 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Notes: intracranial hypertension requiring treatment with mannitol, barbiturate coma, decompressive craniectomy or that resulted in neurological deterioration or death
Frequency: 7 affected / 38 at risk

Adverse event: meningitis or ventriculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: cardiac arrest with CPR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Gangrene of extremities
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypotension due to barbiturate coma
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Upper extremity deep venous thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension (mean blood pressure less than 60 mmHg) requiring treatment with pressors
Frequency: 10 affected / 38 at risk

Adverse event: Abdominal compartment syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Incarcerated inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Severe anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hemoglobin concentration less than 6 gm/dl
Frequency: 1 affected / 38 at risk

Adverse event: Other severe hematologic disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 38 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rhabdomyalysis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 38 at risk

Adverse event: Severe metabolic acidosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cerebrospinal fluid leak
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Brain tissue hypoxia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Delayed or recurrent intracranial hematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Intracranial pressure increased
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Pneumocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Lower extremity deep venous thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Upper extremity deep vein thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 38 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Elevated transaminases
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 38 at risk

Adverse event: Other hematologic disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 38 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hypothermia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Decubitis ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Exposure keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 38 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Airway obstruction post-extubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 38 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Febrile transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 38 at risk

Adverse event: Brain death
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Brain tissue hypoxia
Serious: yes
Organ System: Nervous system disorders
Notes: Brain tissue pO2 less than 10 mmHg for more than 10 minutes
Frequency: 4 affected / 64 at risk

Adverse event: delayed or recurrent intracranial hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: new hematoma or increase in hematoma after initial CT scan, or recurrence of a hematoma after surgical evacuation
Frequency: 13 affected / 64 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Notes: intracranial hypertension requiring treatment with mannitol, barbiturate coma, decompressive craniectomy or that resulted in neurological deterioration or death
Frequency: 14 affected / 64 at risk

Adverse event: meningitis or ventriculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Lower extremity deep venous thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 64 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: cardiac arrest with CPR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hypotension due to barbiturate coma
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 64 at risk

Adverse event: Upper extremity deep venous thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 64 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension (mean blood pressure less than 60 mmHg) requiring treatment with pressors
Frequency: 15 affected / 64 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Other severe hematologic disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 64 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 64 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 64 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Airway obstruction post-extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 64 at risk

Adverse event: Cerebrospinal fluid leak
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Brain tissue hypoxia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 64 at risk

Adverse event: Delayed or recurrent intracranial hematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 64 at risk

Adverse event: Intracranial pressure increased
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 64 at risk

Adverse event: Pneumocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 64 at risk

Adverse event: Lower extremity deep venous thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 64 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hypotension from barbiturate coma
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Upper extremity deep vein thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 64 at risk

Adverse event: Upper GI bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Elevated transaminases
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 64 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 64 at risk

Adverse event: Other hematologic disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 64 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 64 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Wound infection, non-central nervous system
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 64 at risk

Adverse event: Rhabdomyalysis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Mixed acid-base abnormality
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Airway obstruction post-extubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 64 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 64 at risk

Adverse event: Brain death
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 98 at risk

Adverse event: Brain tissue hypoxia
Serious: yes
Organ System: Nervous system disorders
Notes: Brain tissue pO2 less than 10 mmHg for more than 10 minutes
Frequency: 8 affected / 98 at risk

Adverse event: delayed or recurrent intracranial hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: new hematoma or increase in hematoma after initial CT scan, or recurrence of a hematoma after surgical evacuation
Frequency: 18 affected / 98 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Notes: intracranial hypertension requiring treatment with mannitol, barbiturate coma, decompressive craniectomy or that resulted in neurological deterioration or death
Frequency: 28 affected / 98 at risk

Adverse event: meningitis or ventriculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: cardiac arrest with CPR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 98 at risk

Adverse event: Hypotension due to barbiturate coma
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 98 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 98 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension (mean blood pressure less than 60 mmHg) requiring treatment with pressors
Frequency: 19 affected / 98 at risk

Adverse event: Abdominal compartment syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: Other severe hematologic disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 98 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Wound infection, non-central nervous system
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 98 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 8 affected / 98 at risk

Adverse event: Infected eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Tongue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: internal jugular vein injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 98 at risk

Adverse event: Severe metabolic acidosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 98 at risk

Adverse event: Severe mixed acid-base disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 98 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Airway obstruction post-extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Severe atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 98 at risk

Adverse event: Cerebrospinal fluid leak
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk

Adverse event: Brain tissue hypoxia
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 98 at risk

Adverse event: Delayed or recurrent intracranial hematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 98 at risk

Adverse event: Intracranial pressure increased
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 98 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 98 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Lower extremity deep venous thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 98 at risk

Adverse event: Upper extremity deep vein thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 98 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 98 at risk

Adverse event: Elevated transaminases
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 98 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 98 at risk

Adverse event: Other hematologic disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 98 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 98 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 98 at risk

Adverse event: Diabetes insipidus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 98 at risk

Adverse event: Diffuse edema
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 98 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 98 at risk

Adverse event: Bleeding complicating a procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Decubitis ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Exposure keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 98 at risk

Adverse event: acute renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 98 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 98 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 98 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 98 at risk

Adverse event: Brain death
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 99 at risk

Adverse event: Brain tissue hypoxia
Serious: yes
Organ System: Nervous system disorders
Notes: Brain tissue pO2 less than 10 mmHg for more than 10 minutes
Frequency: 10 affected / 99 at risk

Adverse event: delayed or recurrent intracranial hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: new hematoma or increase in hematoma after initial CT scan, or recurrence of a hematoma after surgical evacuation
Frequency: 15 affected / 99 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Notes: intracranial hypertension requiring treatment with mannitol, barbiturate coma, decompressive craniectomy or that resulted in neurological deterioration or death
Frequency: 22 affected / 99 at risk

Adverse event: meningitis or ventriculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: cardiac arrest with CPR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 99 at risk

Adverse event: Hypotension due to barbiturate coma
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 99 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension (mean blood pressure less than 60 mmHg) requiring treatment with pressors
Frequency: 25 affected / 99 at risk

Adverse event: Abdominal compartment syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Other severe hematologic disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Wound infection, non-central nervous system
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 99 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 99 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Rhabdomyalysis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: internal jugular vein injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 99 at risk

Adverse event: Severe metabolic acidosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 99 at risk

Adverse event: Severe mixed acid-base disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 99 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Airway obstruction post-extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 99 at risk

Adverse event: Cerebrospinal fluid leak
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Brain tissue hypoxia
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 99 at risk

Adverse event: Delayed or recurrent intracranial hematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 99 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Intracranial pressure increased
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 99 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 99 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Lower extremity deep venous thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 99 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypotension from barbiturate coma
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Upper extremity deep vein thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 99 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 99 at risk

Adverse event: Elevated transaminases
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 99 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 66 affected / 99 at risk

Adverse event: Other hematologic disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 99 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 99 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Wound infection, non-central nervous system
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Diabetes insipidus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 99 at risk

Adverse event: Diffuse edema
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 99 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypothermia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Bleeding complicating a procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Decubitis ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 99 at risk

Adverse event: Exposure keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 99 at risk

Adverse event: Rhabdomyalysis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: acute renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 99 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 99 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Airway obstruction post-extubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 99 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 99 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 99 at risk

Adverse event: Brain death
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 101 at risk

Adverse event: Brain tissue hypoxia
Serious: yes
Organ System: Nervous system disorders
Notes: Brain tissue pO2 less than 10 mmHg for more than 10 minutes
Frequency: 5 affected / 101 at risk

Adverse event: delayed or recurrent intracranial hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: new hematoma or increase in hematoma after initial CT scan, or recurrence of a hematoma after surgical evacuation
Frequency: 26 affected / 101 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Notes: intracranial hypertension requiring treatment with mannitol, barbiturate coma, decompressive craniectomy or that resulted in neurological deterioration or death
Frequency: 27 affected / 101 at risk

Adverse event: meningitis or ventriculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Lower extremity deep venous thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: cardiac arrest with CPR
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 101 at risk

Adverse event: Gangrene of extremities
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 101 at risk

Adverse event: Hypotension due to barbiturate coma
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 101 at risk

Adverse event: Upper extremity deep venous thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 101 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 101 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension (mean blood pressure less than 60 mmHg) requiring treatment with pressors
Frequency: 19 affected / 101 at risk

Adverse event: Abdominal compartment syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Incarcerated inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Severe anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hemoglobin concentration less than 6 gm/dl
Frequency: 1 affected / 101 at risk

Adverse event: Other severe hematologic disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 101 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 101 at risk

Adverse event: Infected eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Tongue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 101 at risk

Adverse event: Severe metabolic acidosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 101 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 101 at risk

Adverse event: Airway obstruction post-extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Severe atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 101 at risk

Adverse event: Cerebrospinal fluid leak
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 101 at risk

Adverse event: Brain tissue hypoxia
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 101 at risk

Adverse event: Delayed or recurrent intracranial hematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 101 at risk

Adverse event: Intracranial pressure increased
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 101 at risk

Adverse event: Pneumocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 101 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Lower extremity deep venous thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 101 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 101 at risk

Adverse event: Upper extremity deep vein thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 101 at risk

Adverse event: Upper GI bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Elevated transaminases
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 101 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 101 at risk

Adverse event: Other hematologic disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 101 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 101 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 101 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 101 at risk

Adverse event: Hypothermia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Decubitis ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Exposure keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 101 at risk

Adverse event: acute renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 101 at risk

Adverse event: Mixed acid-base abnormality
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 101 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 101 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Febrile transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 101 at risk