Study: NCT00562354

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 134 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 134 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pericoronitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 53 affected / 134 at risk

Adverse event: Injection site movement impairment
Serious: no
Organ System: General disorders
Frequency: 48 affected / 134 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 134 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 134 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 134 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 134 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 134 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 134 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 134 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 134 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 134 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 134 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 134 at risk

Adverse event: Redness: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Redness: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Redness: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Swelling: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 99 at risk

Adverse event: Swelling: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Swelling: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Pain: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 60 affected / 115 at risk

Adverse event: Pain: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 113 at risk

Adverse event: Pain: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 101 at risk

Adverse event: Pain: severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Limitation of arm movement: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 115 at risk

Adverse event: Limitation of arm movement: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 114 at risk

Adverse event: Limitation of arm movement: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Limitation of arm movement: severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 97 at risk

Adverse event: Fever: any ≥37.5 degrees Celsius (C)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 98 at risk

Adverse event: Fever: mild ≥37.5 degrees to <38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 2 affected / 98 at risk

Adverse event: Fever: moderate ≥38.5 degrees to <39 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 26 affected / 100 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 15 affected / 101 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 8 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 97 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 16 affected / 99 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 105 at risk

Adverse event: Any aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 98 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 100 at risk

Adverse event: Any aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 136 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 136 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Gingival disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 52 affected / 136 at risk

Adverse event: Injection site movement impairment
Serious: no
Organ System: General disorders
Frequency: 54 affected / 136 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 136 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 25 affected / 136 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 136 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 136 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 136 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 136 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 136 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 136 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 136 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Redness: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 110 at risk

Adverse event: Redness: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 110 at risk

Adverse event: Redness: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 108 at risk

Adverse event: Redness: severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Swelling: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 109 at risk

Adverse event: Swelling: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 109 at risk

Adverse event: Swelling: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 108 at risk

Adverse event: Swelling: severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pain: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 115 at risk

Adverse event: Pain: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 115 at risk

Adverse event: Pain: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 107 at risk

Adverse event: Limitation of arm movement: any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 118 at risk

Adverse event: Limitation of arm movement: mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 118 at risk

Adverse event: Limitation of arm movement: moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 107 at risk

Adverse event: Limitation of arm movement: severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Fever: any ≥37.5 degrees Celsius (C)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 107 at risk

Adverse event: Fever: mild ≥37.5 degrees to <38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 107 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 111 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 12 affected / 111 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 14 affected / 107 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 10 affected / 108 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 112 at risk

Adverse event: Any aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 110 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 110 at risk

Adverse event: Any aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 109 at risk