Study: NCT00490919

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 256 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 256 at risk

Adverse event: Drug abuser
Serious: yes
Organ System: Social circumstances
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 256 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 32 affected / 256 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 11 affected / 256 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 9 affected / 256 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 11 affected / 256 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 9 affected / 256 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 12 affected / 256 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 10 affected / 256 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 4 affected / 256 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 14 affected / 256 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 283 at risk

Adverse event: Homicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 283 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 283 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 283 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 31 affected / 283 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 5 affected / 283 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 3 affected / 283 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 19 affected / 283 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 14 affected / 283 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 7 affected / 283 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 3 affected / 283 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 6 affected / 283 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 14 affected / 283 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1024 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 240 affected / 1024 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 77 affected / 1024 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 67 affected / 1024 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 87 affected / 1024 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 32 affected / 1024 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 18 affected / 1024 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 102 affected / 1024 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 84 affected / 1024 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments were used.
Frequency: 100 affected / 1024 at risk