Study: NCT00884377

Adverse event: Accute gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severe; resolved; unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Osteoarthritis, left acromioclavicular joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate; resolved; unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Injury, spine trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Severe; resolved; unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Moderate; resolved; unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Transanal resection of carcinoid tumor
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Moderate; resolved; unrelated
Frequency: 1 affected / 28 at risk

Adverse event: No blanching with pressure
Serious: no
Organ System: Vascular disorders
Notes: Local (lesion related)
Frequency: 1 affected / 28 at risk

Adverse event: Site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 5 affected / 28 at risk

Adverse event: Site eschar
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local (lesion related)
Frequency: 9 affected / 28 at risk

Adverse event: Site infection
Serious: no
Organ System: Infections and infestations
Notes: Local (lesion related)
Frequency: 1 affected / 28 at risk

Adverse event: Site pain
Serious: no
Organ System: General disorders
Notes: Local (lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Site papules
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 6 affected / 28 at risk

Adverse event: Site plaque
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local (lesion related)
Frequency: 10 affected / 28 at risk

Adverse event: Satellite lesions
Serious: no
Organ System: Infections and infestations
Notes: Local (lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Site scaley
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 11 affected / 28 at risk

Adverse event: Site tenderness
Serious: no
Organ System: General disorders
Notes: Local (lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Site ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local (lesion related)
Frequency: 11 affected / 28 at risk

Adverse event: Site verrucous
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Local (lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Site weeping
Serious: no
Organ System: General disorders
Notes: Local (lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: General (non-lesion related)
Frequency: 5 affected / 28 at risk

Adverse event: Ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: General (non-lesion related)
Frequency: 7 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: General (non-lesion related)
Frequency: 7 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: General (non-lesion related)
Frequency: 8 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General (non-lesion related)
Frequency: 28 affected / 28 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: General (non-lesion related)
Frequency: 4 affected / 28 at risk

Adverse event: Site extravasation
Serious: no
Organ System: General disorders
Notes: General (non-lesion related)
Frequency: 5 affected / 28 at risk

Adverse event: Chemical hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 19 affected / 28 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 23 affected / 28 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 13 affected / 28 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 9 affected / 28 at risk

Adverse event: EKG T-wave abnormal
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: QRS axis abnormal
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 4 affected / 28 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 9 affected / 28 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Monocyte count increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 7 affected / 28 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 8 affected / 28 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 6 affected / 28 at risk

Adverse event: Blood chloride increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 5 affected / 28 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General (non-lesion related)
Frequency: 22 affected / 28 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General (non-lesion related)
Frequency: 12 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: General (non-lesion related)
Frequency: 21 affected / 28 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: General (non-lesion related)
Frequency: 7 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Crohn's disease exacerbation
Serious: yes
Organ System: Immune system disorders
Notes: Moderate; resolved; unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Basal cell carcinoma, superficial
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; resolved; unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Lesion site blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 25 affected / 28 at risk

Adverse event: No blanching with pressure
Serious: no
Organ System: Vascular disorders
Notes: Local (lesion related)
Frequency: 18 affected / 28 at risk

Adverse event: Site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 21 affected / 28 at risk

Adverse event: Site eschar
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local (lesion related)
Frequency: 25 affected / 28 at risk

Adverse event: Site infection
Serious: no
Organ System: Infections and infestations
Notes: Local (lesion related)
Frequency: 5 affected / 28 at risk

Adverse event: Site keloid formation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Site pain
Serious: no
Organ System: General disorders
Notes: Local (lesion related)
Frequency: 11 affected / 28 at risk

Adverse event: Site papules
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Site plaque
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local (lesion related)
Frequency: 7 affected / 28 at risk

Adverse event: Site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 6 affected / 28 at risk

Adverse event: Satellite lesions
Serious: no
Organ System: Infections and infestations
Notes: Local (lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Site scaley
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local (lesion related)
Frequency: 6 affected / 28 at risk

Adverse event: Site tenderness
Serious: no
Organ System: General disorders
Notes: Local (lesion related)
Frequency: 5 affected / 28 at risk

Adverse event: Site ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local (lesion related)
Frequency: 14 affected / 28 at risk

Adverse event: Site verrucous
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Local (lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Site weeping
Serious: no
Organ System: General disorders
Notes: Local (lesion related)
Frequency: 23 affected / 28 at risk

Adverse event: Site oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local (lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: General (non-lesion related)
Frequency: 4 affected / 28 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: General (non-lesion related)
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General (non-lesion related)
Frequency: 7 affected / 28 at risk

Adverse event: EKG T-wave abnormal
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: QRS axis abnormal
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 4 affected / 28 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Monocyte count increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 1 affected / 28 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Blood chloride increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 1 affected / 28 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Notes: General (non-lesion related)
Frequency: 3 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General (non-lesion related)
Frequency: 6 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General (non-lesion related)
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: General (non-lesion related)
Frequency: 6 affected / 28 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: General (non-lesion related)
Frequency: 2 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: General (non-lesion related)
Frequency: 1 affected / 28 at risk