Study: NCT00315458

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and non-systematic assessments.
Frequency: 1 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 4 affected / 51 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 6 affected / 51 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 3 affected / 51 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 5 affected / 51 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 51 at risk

Adverse event: Acute myocardial infarction - DEATH
Serious: yes
Organ System: Cardiac disorders
Notes: DEATH (systematic and nonsystematic assessments)
Frequency: 1 affected / 56 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 6 affected / 56 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 4 affected / 56 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 7 affected / 56 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 56 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 6 affected / 56 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 3 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 56 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 3 affected / 56 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 56 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 56 at risk

Adverse event: Acute exacerbation of COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 25 affected / 159 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 10 affected / 159 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 16 affected / 159 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 6 affected / 159 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 159 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 2 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 16 affected / 159 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 159 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 11 affected / 159 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 3 affected / 159 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 6 affected / 159 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Acute myocardial infarction - DEATH
Serious: yes
Organ System: Cardiac disorders
Notes: DEATH (systematic and nonsystematic assessments)
Frequency: 1 affected / 159 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Acute exacerbation of COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Recurrent Major Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 32 affected / 159 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 15 affected / 159 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 23 affected / 159 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 9 affected / 159 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 8 affected / 159 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 5 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 22 affected / 159 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 6 affected / 159 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 12 affected / 159 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 8 affected / 159 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 11 affected / 159 at risk