Study: NCT00343915

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 257 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 257 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 257 at risk

Adverse event: Pain; Dose 1
Serious: no
Organ System: General disorders
Frequency: 121 affected / 253 at risk

Adverse event: Redness; Dose 1
Serious: no
Organ System: General disorders
Frequency: 30 affected / 253 at risk

Adverse event: Swelling; Dose 1
Serious: no
Organ System: General disorders
Frequency: 18 affected / 253 at risk

Adverse event: Pain; Dose 2
Serious: no
Organ System: General disorders
Frequency: 42 affected / 252 at risk

Adverse event: Redness; Dose 2
Serious: no
Organ System: General disorders
Frequency: 15 affected / 252 at risk

Adverse event: Pain; Dose 3
Serious: no
Organ System: General disorders
Frequency: 106 affected / 250 at risk

Adverse event: Redness; Dose 3
Serious: no
Organ System: General disorders
Frequency: 29 affected / 250 at risk

Adverse event: Swelling; Dose 3
Serious: no
Organ System: General disorders
Frequency: 14 affected / 250 at risk

Adverse event: Pain; Across Doses
Serious: no
Organ System: General disorders
Frequency: 155 affected / 253 at risk

Adverse event: Redness; Across Doses
Serious: no
Organ System: General disorders
Frequency: 50 affected / 253 at risk

Adverse event: Swelling; Across Doses
Serious: no
Organ System: General disorders
Frequency: 27 affected / 253 at risk

Adverse event: Fatigue; Dose 1
Serious: no
Organ System: General disorders
Frequency: 50 affected / 253 at risk

Adverse event: Gastrointestinal symptoms; Dose 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 253 at risk

Adverse event: Headache; Dose 1
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 253 at risk

Adverse event: Fatigue; Dose 2
Serious: no
Organ System: General disorders
Frequency: 37 affected / 252 at risk

Adverse event: Gastrointestinal symptoms; Dose 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 252 at risk

Adverse event: Headache; Dose 2
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 252 at risk

Adverse event: Fatigue; Dose 3
Serious: no
Organ System: General disorders
Frequency: 49 affected / 250 at risk

Adverse event: Gastrointestinal symptoms; Dose 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 250 at risk

Adverse event: Fever; Dose 3
Serious: no
Organ System: General disorders
Frequency: 13 affected / 250 at risk

Adverse event: Fatigue; Across Doses
Serious: no
Organ System: General disorders
Frequency: 77 affected / 253 at risk

Adverse event: Gastrointestinal symptoms; Across Doses
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 253 at risk

Adverse event: Headache; Across Doses
Serious: no
Organ System: Nervous system disorders
Frequency: 78 affected / 253 at risk

Adverse event: Fever; Across Doses
Serious: no
Organ System: General disorders
Frequency: 17 affected / 253 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 257 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 257 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 257 at risk

Adverse event: Headache; Dose 3
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 250 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Pain; Dose 1
Serious: no
Organ System: General disorders
Frequency: 44 affected / 121 at risk

Adverse event: Redness; Dose 1
Serious: no
Organ System: General disorders
Frequency: 10 affected / 121 at risk

Adverse event: Swelling; Dose 1
Serious: no
Organ System: General disorders
Frequency: 8 affected / 121 at risk

Adverse event: Pain; Dose 2
Serious: no
Organ System: General disorders
Frequency: 38 affected / 119 at risk

Adverse event: Redness; Dose 2
Serious: no
Organ System: General disorders
Frequency: 15 affected / 119 at risk

Adverse event: Pain; Dose 3
Serious: no
Organ System: General disorders
Frequency: 35 affected / 118 at risk

Adverse event: Redness; Dose 3
Serious: no
Organ System: General disorders
Frequency: 11 affected / 118 at risk

Adverse event: Swelling; Dose 3
Serious: no
Organ System: General disorders
Frequency: 6 affected / 118 at risk

Adverse event: Pain; Across Doses
Serious: no
Organ System: General disorders
Frequency: 74 affected / 121 at risk

Adverse event: Redness; Across Doses
Serious: no
Organ System: General disorders
Frequency: 28 affected / 121 at risk

Adverse event: Swelling; Across Doses
Serious: no
Organ System: General disorders
Frequency: 15 affected / 121 at risk

Adverse event: Fatigue; Dose 1
Serious: no
Organ System: General disorders
Frequency: 26 affected / 121 at risk

Adverse event: Gastrointestinal symptoms; Dose 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 121 at risk

Adverse event: Headache; Dose 1
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 121 at risk

Adverse event: Fatigue; Dose 2
Serious: no
Organ System: General disorders
Frequency: 18 affected / 119 at risk

Adverse event: Gastrointestinal symptoms; Dose 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 119 at risk

Adverse event: Headache; Dose 2
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 119 at risk

Adverse event: Fatigue; Dose 3
Serious: no
Organ System: General disorders
Frequency: 20 affected / 118 at risk

Adverse event: Gastrointestinal symptoms; Dose 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 118 at risk

Adverse event: Fever; Dose 3
Serious: no
Organ System: General disorders
Frequency: 9 affected / 118 at risk

Adverse event: Fatigue; Across Doses
Serious: no
Organ System: General disorders
Frequency: 46 affected / 121 at risk

Adverse event: Gastrointestinal symptoms; Across Doses
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 121 at risk

Adverse event: Headache; Across Doses
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 121 at risk

Adverse event: Fever; Across Doses
Serious: no
Organ System: General disorders
Frequency: 14 affected / 121 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 125 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 125 at risk

Adverse event: Headache; Dose 3
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 118 at risk