Study: NCT00135668

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Serratia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Post procedural discharge
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Blood pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac output decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Central venous pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Withdrawal hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 50 at risk

Adverse event: Superior mesenteric artery syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 50 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 50 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 50 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 50 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 50 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 50 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 50 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 50 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 50 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 50 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 50 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 50 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 50 at risk

Adverse event: Withdrawal hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 50 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Infusion site extravasation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Blood pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 49 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 49 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 49 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 49 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 49 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 49 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 49 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 49 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 49 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 49 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 49 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 49 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 49 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 49 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 49 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 49 at risk

Adverse event: Withdrawal hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 49 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Blood pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 53 at risk

Adverse event: Heart rate increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 53 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 53 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 53 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 53 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 53 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 53 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 53 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 53 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 53 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 53 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 53 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 53 at risk

Adverse event: Withdrawal hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 53 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 53 at risk

Adverse event: Pseudocyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Blood pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Cauda equina syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hypotonic urinary bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 51 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 51 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 51 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 51 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 51 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 51 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 51 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 51 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 51 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 51 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 51 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 41 affected / 51 at risk

Adverse event: Withdrawal hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 51 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 51 at risk