Study: NCT00107900

Adverse event: obstructive inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 85 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 85 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 85 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 85 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 6 affected / 85 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 85 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 85 at risk

Adverse event: anaemia post-operative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 85 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 75 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 75 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 75 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 75 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 75 at risk

Adverse event: anaemia post-operative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 129 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 129 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Blood alkaline phosphatase abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 129 at risk

Adverse event: Alanine aminotransferase abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 129 at risk

Adverse event: Blood bilirubin abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 129 at risk

Adverse event: aspartate amniotransferase abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 129 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: hepatic enzyme increase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 129 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 129 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 129 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 129 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 129 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 12 affected / 129 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 129 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 129 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 129 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 129 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 129 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 129 at risk

Adverse event: anaemia post-operative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 129 at risk

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

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

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

Adverse event: Sciatic nerve palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

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

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

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 99 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 99 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 99 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 99 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 99 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 99 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 99 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 13 affected / 99 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 15 affected / 99 at risk

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 99 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 99 at risk

Adverse event: anaemia post-operative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 99 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: postprocedural fistula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Anaemia postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: lymphadentis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 115 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 115 at risk

Adverse event: blood alkaline phosphatase increase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 115 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 115 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 115 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 115 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 115 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 11 affected / 115 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 115 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 115 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 5 affected / 115 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 115 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 115 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 115 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 115 at risk

Adverse event: anaemia post-operative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 115 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 103 at risk

Adverse event: Anaemia postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pallor
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 103 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 103 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 103 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 103 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 103 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 103 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 103 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 6 affected / 103 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 4 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 103 at risk

Adverse event: anaemia post-operative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 103 at risk