Study: NCT00420407

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: General disorders
Notes: includes cardiac and cardiopulmonay arrest
Frequency: 4 affected / 41 at risk

Adverse event: Exsanguination
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: General disorders
Notes: includes refractory hemorrhagic shock(1)
Frequency: 1 affected / 41 at risk

Adverse event: Multisystem Trauma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Pulseless electrical activity, pulseless ventricular tachycardia, supraventricular tachycardia, intermittent
Frequency: 1 affected / 41 at risk

Adverse event: Dehiscence, wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Systemic Inflamatory Response Syndrome (SIRS)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Shock, Septic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: includes multiple organ dysfunction.
Frequency: 2 affected / 41 at risk

Adverse event: Traumatic Brain Injury (TBI)
Serious: yes
Organ System: Nervous system disorders
Notes: nonsurvivable TBI
Frequency: 3 affected / 41 at risk

Adverse event: Acute Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Empyema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Pulmonary Emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: included pulmonary embolis and embolism
Frequency: 2 affected / 41 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Systemic candida
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypoperfusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 41 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 41 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: included intermittent Hyperglycemia
Frequency: 9 affected / 41 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypoglycemia
Frequency: 1 affected / 41 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypocalcemia
Frequency: 5 affected / 41 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypokalemia
Frequency: 5 affected / 41 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Endocrine disorders
Notes: included intermittent hypomagnesemia
Frequency: 2 affected / 41 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypophosphatemia
Frequency: 7 affected / 41 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Candida infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypernatremia
Frequency: 1 affected / 41 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hyponatermia
Frequency: 1 affected / 41 at risk

Adverse event: Bowel Distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: includeds intermittent
Frequency: 6 affected / 41 at risk

Adverse event: Elevated gastric residuals
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes intermittent
Frequency: 2 affected / 41 at risk

Adverse event: Oliguria
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary retention, failur to void
Frequency: 2 affected / 41 at risk

Adverse event: Incontinence Urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Superficial vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 41 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Elevated Liver Function Tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Elevated Temperature
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Postitive blood cultures
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Itching, intermittant
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Notes: Hepatic/pulmonary
Frequency: 6 affected / 41 at risk

Adverse event: Rhabdomyolosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Allergic reaction to enalapril
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Delirium Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Azotaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Elevated Lactic Acid
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Notes: included intermittent
Frequency: 2 affected / 41 at risk

Adverse event: insomia
Serious: no
Organ System: Nervous system disorders
Notes: included intermittent
Frequency: 5 affected / 41 at risk

Adverse event: anxiousness
Serious: no
Organ System: Nervous system disorders
Notes: intermittent
Frequency: 1 affected / 41 at risk

Adverse event: Hyperchloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: intermittent
Frequency: 1 affected / 41 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Acute respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pleural Effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unilateral and/or bilateral
Frequency: 5 affected / 41 at risk

Adverse event: Exacerbation COPD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: intermittent
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: includes lung infection
Frequency: 2 affected / 41 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: General disorders
Notes: includes cardiac and cardiopulmonay arrest
Frequency: 3 affected / 40 at risk

Adverse event: Cardiac Dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Exsanguination
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: General disorders
Notes: includes refractory hemorrhagic shock(1)
Frequency: 3 affected / 40 at risk

Adverse event: Hypertenson
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Pulseless electrical activity, pulseless ventricular tachycardia, supraventricular tachycardia, intermittent
Frequency: 2 affected / 40 at risk

Adverse event: reperfusion syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ogilvies Syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Upper GI bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: locations - Femoral, popliteal, subclavian
Frequency: 3 affected / 40 at risk

Adverse event: Heparin induced thrombocytopenia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Sepsis, abdominal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ischemic Necrosis Bilateral Lower Extremities
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cellutlitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: includes multiple organ dysfunction.
Frequency: 4 affected / 40 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Traumatic Brain Injury (TBI)
Serious: yes
Organ System: Nervous system disorders
Notes: nonsurvivable TBI
Frequency: 4 affected / 40 at risk

Adverse event: Acute Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pulmonary Emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: included pulmonary embolis and embolism
Frequency: 2 affected / 40 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Renal Insufficiency, worsening
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Diabetes insipidus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: included intermittent Hyperglycemia
Frequency: 6 affected / 40 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypoglycemia
Frequency: 2 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypocalcemia
Frequency: 3 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypokalemia
Frequency: 4 affected / 40 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Endocrine disorders
Notes: included intermittent hypomagnesemia
Frequency: 1 affected / 40 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hypophosphatemia
Frequency: 2 affected / 40 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Endocrine disorders
Notes: includes intermittent hyperkalemia
Frequency: 1 affected / 40 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: includeds intermittent
Frequency: 5 affected / 40 at risk

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

Adverse event: Elevated gastric residuals
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes intermittent
Frequency: 3 affected / 40 at risk

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 40 at risk

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

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

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

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

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

Adverse event: Elevated Temperature
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 40 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Infiltration, skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

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

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Notes: Hepatic/pulmonary
Frequency: 3 affected / 40 at risk

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

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: bilateral lower extremity edema
Frequency: 1 affected / 40 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

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

Adverse event: Hyper-reflexia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Notes: included intermittent
Frequency: 1 affected / 40 at risk

Adverse event: insomia
Serious: no
Organ System: Nervous system disorders
Notes: included intermittent
Frequency: 1 affected / 40 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

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

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

Adverse event: Pleural Effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unilateral and/or bilateral
Frequency: 1 affected / 40 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: intermittent
Frequency: 2 affected / 40 at risk

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

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: includes lung infection
Frequency: 1 affected / 40 at risk

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