Study: NCT00522171

Adverse event: wound dehiscence, MedDRA 10.0
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Nausea; MedDRA 10.0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 15 at risk

Adverse event: constipations; MedDRA 10.0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Chills; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: impaired healing; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: infection; MedDRA 10.0
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: staphyloccal infection; MedDRA 10.0
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: abdominal distension; MedDRA 10.0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: abdominal haematoma; MedDRA 10.0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: abdominal rigidity; MedDRA 10.0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: seroma; MedDRA 10.0
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 15 at risk

Adverse event: anaemia postoperative; MedDRA 10.0
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: medical device pain; MedDRA 10.0
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Post lumbar puncture syndrome; MedDRA 10.0
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: body temperature increased; MedDRA 10.0
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: lumbar puncture; MedDRA 10.0
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: fluid retention; MedDRA 10.0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 15 at risk

Adverse event: dizziness; MedDRA 10.0
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: hypoaesthesia; MedDRA 10.0
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: intercranial hypotension; MedDRA 10.0
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: anxiety; MedDRA 10.0
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: urge incontinence; MedDRA 10.0
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: perineal pain; MedDRA 10.0
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: pruritis; MedDRA 10.0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: blister; MedDRA 10.0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Application site Excoriation, medDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Asthenia, MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: dyspnoea, MedDRA Version 10.0
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: ANAEMIA ,MedDRA 10.0
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vertigo, MedDRA 10.0
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea; MedDRA 10.0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 15 at risk

Adverse event: constipations; MedDRA 10.0
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Chills; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: impaired healing; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Application site reaction; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Application site vesicles; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: fatigue; MedDRA 10.0
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: sinusitis;MedDRA 10.0
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: vaginal infection; MedDRA 10.0
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: device leakage; MedDRA 10.0
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: procedural nausea; MedDRA 10.0
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: body temperature increased; MedDRA 10.0
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: blood pressure decreased; MedDRA 10.0
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: fluid retention; MedDRA 10.0
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 15 at risk

Adverse event: pain in extremity; MedDRA 10.0
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: dizziness; MedDRA 10.0
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 15 at risk

Adverse event: headache; MedDRA 10.0
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: syncope; MedDRA 10.0
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: anxiety; MedDRA 10.0
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: insomnia; MedDRA 10.0
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: nasal congestion; MedDRA 10.0
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: respiratory disorder; MedDRA 10.0
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: pruritis; MedDRA 10.0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 15 at risk

Adverse event: erythema; MedDRA 10.0
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: hypertension; MedDRA 10.0
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: ischaemia; MedDRA 10.0
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: thrombosis; MedDRA 10.0
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk