Study: NCT00313014

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 2 affected / 221 at risk

Adverse event: Left lower lobe pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Depression worsening
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Depressed respiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Exacerbation of COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Left pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 221 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 18 affected / 221 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 7 affected / 221 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 5 affected / 221 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 221 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 12 affected / 221 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 17 affected / 221 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 3 affected / 221 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 5 affected / 221 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 12 affected / 221 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 4 affected / 221 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 5 affected / 221 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 5 affected / 221 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Intractable vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Increased total bilirubin
Serious: yes
Organ System: Investigations
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Right heel infection
Serious: yes
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 219 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 27 affected / 219 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 14 affected / 219 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 11 affected / 219 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 22 affected / 219 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 29 affected / 219 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 20 affected / 219 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 4 affected / 219 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 219 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 25 affected / 219 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 219 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 219 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 219 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Worsening chronic cholecycstitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Clear cell carcinoma left ovary metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Lower extremity lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Lumbar spinal stenosis with diminution of L4-5
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Acute bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Acute exacerbation of chronic obstructive pulmonary disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Acute axonal motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 220 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 18 affected / 220 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 14 affected / 220 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 9 affected / 220 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 19 affected / 220 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 20 affected / 220 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 13 affected / 220 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 220 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 4 affected / 220 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 21 affected / 220 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 11 affected / 220 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 8 affected / 220 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 7 affected / 220 at risk

Adverse event: Arrhythmia - DEATH
Serious: yes
Organ System: Cardiac disorders
Notes: Death Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Brain arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 2 affected / 1160 at risk

Adverse event: Right heel diabetic foot abscess
Serious: yes
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Cocaine toxicity - DEATH
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Death Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Drowning - DEATH
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Death Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Shunt malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Fracture distal right radius
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Nerve entrapment
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Hematoma, right thigh
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 1160 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 174 affected / 1160 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 46 affected / 1160 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 60 affected / 1160 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 38 affected / 1160 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 102 affected / 1160 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 38 affected / 1160 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 4 affected / 1160 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 8 affected / 1160 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 124 affected / 1160 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 67 affected / 1160 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 62 affected / 1160 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 13 affected / 1160 at risk