Study: NCT00320801

Adverse event: Worsening of reflex sympathetic dystrophy
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 47 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 47 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 3 affected / 47 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 3 affected / 47 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 47 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 3 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 47 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 47 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 3 affected / 47 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 47 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 47 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 47 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 3 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 49 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 49 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 49 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 49 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 6 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 49 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 49 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 49 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 49 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 49 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 188 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Somnolent
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 30 affected / 188 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 16 affected / 188 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 188 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 188 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 9 affected / 188 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 188 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 3 affected / 188 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 16 affected / 188 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 15 affected / 188 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 7 affected / 188 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 188 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 6 affected / 188 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 8 affected / 188 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 2 affected / 188 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Somnolent
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Worsening of reflex sympathetic dystrophy
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Grade 2 splenic laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Right occipital condyle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Comminuted pelvic fracture left
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Right tibia-fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Comminuted acetabulum left
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Right lower lobe contusion on chest
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Left post distal shaft fibular fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Left lower lobe contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Subarachnoid hemorrhage of fourth ventricle
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Left hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments.
Frequency: 1 affected / 188 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 188 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 38 affected / 188 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 21 affected / 188 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 9 affected / 188 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 18 affected / 188 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 17 affected / 188 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 14 affected / 188 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 16 affected / 188 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 4 affected / 188 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 24 affected / 188 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 20 affected / 188 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 5 affected / 188 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 15 affected / 188 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 11 affected / 188 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 10 affected / 188 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments.
Frequency: 9 affected / 188 at risk