Study: NCT00312221

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 136 at risk

Adverse event: Liver cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 136 at risk

Adverse event: Possible bone cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 136 at risk

Adverse event: Worsening asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 136 at risk

Adverse event: Acid reflux
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 4 affected / 136 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 3 affected / 136 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 136 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 13 affected / 136 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 5 affected / 136 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 9 affected / 136 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 136 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 6 affected / 136 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 136 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 136 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 7 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 10 affected / 136 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 136 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 136 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 149 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 149 at risk

Adverse event: Exacerbation of Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 149 at risk

Adverse event: Exacerbation of lumbar spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 149 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessment

"Fall" and "Fell" are listed as 2 separate categories.
Frequency: 1 affected / 149 at risk

Adverse event: OxyIR abuse
Serious: yes
Organ System: Social circumstances
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 149 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 149 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 149 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 149 at risk

Adverse event: End stage OA of the right knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 149 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 16 affected / 149 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 8 affected / 149 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 8 affected / 149 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 22 affected / 149 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 9 affected / 149 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 14 affected / 149 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 149 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 6 affected / 149 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 8 affected / 149 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 9 affected / 149 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 149 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 22 affected / 149 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 10 affected / 149 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 149 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 133 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 133 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 133 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 133 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 133 at risk

Adverse event: Fell
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessment

"Fall" and "Fell" are listed as 2 separate categories.
Frequency: 1 affected / 133 at risk

Adverse event: Fractured left hip
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 133 at risk

Adverse event: GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 133 at risk

Adverse event: Recurrent L4-L5 disc herniation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 133 at risk

Adverse event: Recurrent L5-S1 disc herniation with impingement of the S1 nerve root
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 133 at risk

Adverse event: Transischemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 17 affected / 133 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 9 affected / 133 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 6 affected / 133 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 6 affected / 133 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 12 affected / 133 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 8 affected / 133 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 5 affected / 133 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 7 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 8 affected / 133 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 133 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 133 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 3 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 16 affected / 133 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 7 affected / 133 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 10 affected / 133 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Chest pain with ischemic episode
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Dermoid ovarian cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Enlarged uterus
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Muscle spasms right knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessment
Frequency: 1 affected / 652 at risk

Adverse event: Postsurgical hip joint dislocation, left hip
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 652 at risk

Adverse event: Prostatic adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 652 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 652 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 652 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 94 affected / 652 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 22 affected / 652 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 32 affected / 652 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 652 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 47 affected / 652 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 9 affected / 652 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 9 affected / 652 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 11 affected / 652 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 652 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments.
Frequency: 9 affected / 652 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 12 affected / 652 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 14 affected / 652 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 70 affected / 652 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 43 affected / 652 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 29 affected / 652 at risk