Study: NCT00565461

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Brugada syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Application site discolouration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 26 affected / 40 at risk

Adverse event: Application site erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 40 at risk

Adverse event: Application site oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 40 at risk

Adverse event: Application site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 40 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 40 at risk

Adverse event: Application site rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 40 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Red blood cells in urine
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Application site discolouration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 40 at risk

Adverse event: Application site erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 40 at risk

Adverse event: Application site oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 40 at risk

Adverse event: Application site erosion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Application site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 40 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 36 affected / 40 at risk

Adverse event: Application site rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 40 at risk

Adverse event: Application site scab
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 40 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Red blood cells in urine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 40 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Application site discolouration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 40 at risk

Adverse event: Application site erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 37 affected / 40 at risk

Adverse event: Application site oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 40 at risk

Adverse event: Application site erosion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 40 at risk

Adverse event: Application site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 40 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 37 affected / 40 at risk

Adverse event: Application site rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 35 affected / 40 at risk

Adverse event: Application site scab
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Red blood cells in urine
Serious: no
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 40 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Application site discolouration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 40 at risk

Adverse event: Application site erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 40 at risk

Adverse event: Application site oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 40 at risk

Adverse event: Application site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 40 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 35 affected / 40 at risk

Adverse event: Application site rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 40 at risk

Adverse event: Application site scab
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 40 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Red blood cells in urine
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 40 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk