Study: NCT00545025

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 160 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache was reported as an unsolicited adverse event (AE).
Frequency: 8 affected / 160 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 160 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 160 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 72 affected / 160 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever was defined as oral temperature ≥ 37.5 degrees Celsius (°C)
Frequency: 27 affected / 160 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 65 affected / 160 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 160 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 23 affected / 160 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 39 affected / 160 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 8 affected / 160 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 143 affected / 160 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 160 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 29 affected / 160 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache was reported as an unsolicited adverse event (AE).
Frequency: 3 affected / 83 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 83 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever was defined as oral temperature ≥ 37.5 degrees Celsius (°C)
Frequency: 2 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 18 affected / 83 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 83 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 57 affected / 83 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 83 at risk