Study: NCT00811577

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 126 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Cholecystitis, Acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Kyphosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pseudarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 126 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 126 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 126 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 46 affected / 126 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 63 affected / 126 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 80 affected / 126 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 14 affected / 126 at risk

Adverse event: Injection site urticaria
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 24 affected / 126 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 126 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 126 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 126 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 126 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 126 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 126 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 3 affected / 24 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 6 affected / 24 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 7 affected / 24 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 2 affected / 24 at risk

Adverse event: Injection site urticaria
Serious: no
Organ System: General disorders
Notes: Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously.
Frequency: 1 affected / 24 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk