Study: NCT01369485

Adverse event: Skin irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: redness,erythema, itching, irritation, blistering
Frequency: 12 affected / 80 at risk

Adverse event: Change in Bowel Habit
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 2 affected / 80 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: UTI
Frequency: 1 affected / 80 at risk

Adverse event: Redness and Itchiness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Redness/erythema and itchiness
Frequency: 18 affected / 80 at risk

Adverse event: Rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Rash
Frequency: 7 affected / 80 at risk

Adverse event: Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Blisters
Frequency: 2 affected / 80 at risk

Adverse event: Allergic Reaction to Sulfa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Allergic Reaction
Frequency: 1 affected / 80 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Chest Pain/Shortness of Breath
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 80 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Sleeping Difficulties
Serious: no
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Burning sensation at Patch Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 1 affected / 80 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 1 affected / 80 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: redness,erythema, itching, irritation, blistering
Frequency: 5 affected / 82 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: UTI
Frequency: 2 affected / 82 at risk

Adverse event: Redness and Itchiness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Redness/erythema and itchiness
Frequency: 12 affected / 82 at risk

Adverse event: Rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Rash
Frequency: 6 affected / 82 at risk

Adverse event: Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Blisters
Frequency: 3 affected / 82 at risk

Adverse event: Allergic Reaction to Sulfa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Allergic Reaction
Frequency: 1 affected / 82 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 82 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 82 at risk

Adverse event: Kidney/Ureteral Stones and bleedling
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Sleeping Difficulties
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Burning sensation at Patch Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 2 affected / 82 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 2 affected / 82 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 1 affected / 82 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: redness,erythema, itching, irritation, blistering
Frequency: 5 affected / 57 at risk

Adverse event: Change in Bowel Habit
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 2 affected / 57 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: UTI
Frequency: 2 affected / 57 at risk

Adverse event: Redness and Itchiness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Redness/erythema and itchiness
Frequency: 7 affected / 57 at risk

Adverse event: Rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Rash
Frequency: 6 affected / 57 at risk

Adverse event: Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Blisters
Frequency: 2 affected / 57 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Chest Pain/Shortness of Breath
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Environmental Allergies
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Nausea/Vomiting due to Food Poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 57 at risk

Adverse event: Kidney/Ureteral Stones and bleedling
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Burning sensation at Patch Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 2 affected / 57 at risk

Adverse event: Pain at Patch Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 1 affected / 57 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 1 affected / 57 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Event not considered related to procedure or treatment.
Frequency: 1 affected / 66 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: redness,erythema, itching, irritation, blistering
Frequency: 12 affected / 66 at risk

Adverse event: Redness and Itchiness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Redness/erythema and itchiness
Frequency: 11 affected / 66 at risk

Adverse event: Rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Rash
Frequency: 7 affected / 66 at risk

Adverse event: Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Blisters
Frequency: 1 affected / 66 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Kidney/Ureteral Stones and bleedling
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 66 at risk

Adverse event: Burning sensation at Patch Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 2 affected / 66 at risk

Adverse event: Pain at Patch Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Sensory
Frequency: 1 affected / 66 at risk