Study: NCT00536744

Adverse event: Application site infections
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 107 at risk

Adverse event: MI and cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 107 at risk

Adverse event: GI Haemmorhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: application site disorders
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 107 at risk

Adverse event: Fall, complication from other procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 107 at risk

Adverse event: dehydration and other disease related problems
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 107 at risk

Adverse event: Arthritis and joint pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: ischemic attack, syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 107 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 107 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Diabetic vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 107 at risk

Adverse event: blood deficiencies
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 107 at risk

Adverse event: cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 107 at risk

Adverse event: hearing disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 107 at risk

Adverse event: eye conditions
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 107 at risk

Adverse event: nausea, stomach discomfort, bowel conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 107 at risk

Adverse event: target site pain, irritation, illnesses
Serious: no
Organ System: General disorders
Frequency: 24 affected / 107 at risk

Adverse event: allergies
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 107 at risk

Adverse event: infections
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 107 at risk

Adverse event: non-ulcer injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 107 at risk

Adverse event: blood tests, weight increase
Serious: no
Organ System: Investigations
Frequency: 11 affected / 107 at risk

Adverse event: anorexia, dehydration, diabetes related conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 107 at risk

Adverse event: joint and muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 107 at risk

Adverse event: headache, syncope, dizziness, ischemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 107 at risk

Adverse event: anxiety, depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 107 at risk

Adverse event: renal failure, incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 107 at risk

Adverse event: prostatic hypoplasia, vulvovaginal burning
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 107 at risk

Adverse event: coughing, congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 107 at risk

Adverse event: blisters, dermatitis, non-ulcer skin conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 107 at risk

Adverse event: arterial stenosis, DVT, hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 107 at risk

Adverse event: Application site infections
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 99 at risk

Adverse event: MI and cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 99 at risk

Adverse event: GI Haemmorhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: application site disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Fall, complication from other procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Bacterial test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 99 at risk

Adverse event: dehydration and other disease related problems
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: ischemic attack, syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 99 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 99 at risk

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

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Diabetic vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: blood deficiencies
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 99 at risk

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

Adverse event: hearing disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 99 at risk

Adverse event: eye conditions
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 99 at risk

Adverse event: nausea, stomach discomfort, bowel conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 99 at risk

Adverse event: target site pain, irritation, illnesses
Serious: no
Organ System: General disorders
Frequency: 31 affected / 99 at risk

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

Adverse event: infections
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 99 at risk

Adverse event: non-ulcer injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 99 at risk

Adverse event: blood tests, weight increase
Serious: no
Organ System: Investigations
Frequency: 16 affected / 99 at risk

Adverse event: anorexia, dehydration, diabetes related conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 99 at risk

Adverse event: joint and muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 99 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 99 at risk

Adverse event: headache, syncope, dizziness, ischemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 99 at risk

Adverse event: anxiety, depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 99 at risk

Adverse event: renal failure, incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 99 at risk

Adverse event: prostatic hypoplasia, vulvovaginal burning
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 99 at risk

Adverse event: coughing, congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 99 at risk

Adverse event: blisters, dermatitis, non-ulcer skin conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 99 at risk

Adverse event: arterial stenosis, DVT, hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 99 at risk