Study: NCT01135524

Adverse event: Aggravated osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 196 at risk

Adverse event: Atypical chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Gangrene right foot
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Herniated lumbar disc
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Left lung pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 196 at risk

Adverse event: Mild myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: DEATH Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Anorectal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Withdrawal symptoms
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Worsening hiatal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 196 at risk

Adverse event: Worsening left hip OA
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Worsening of lumbar stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 196 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 11 affected / 196 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 22 affected / 196 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 20 affected / 196 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 19 affected / 196 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 9 affected / 196 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 31 affected / 196 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 9 affected / 196 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 12 affected / 196 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 10 affected / 196 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 10 affected / 196 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 10 affected / 196 at risk