Study: NCT00981175

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Gastroenteritis Not Otherwise Specified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 201 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 201 at risk

Adverse event: Injection Site Reaction Not Otherwise Specified
Serious: no
Organ System: General disorders
Frequency: 6 affected / 201 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 11 affected / 201 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 201 at risk

Adverse event: Viral Infection Not Otherwise Specified
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 201 at risk

Adverse event: Viral Infection Not Otherwise Specified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 199 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 199 at risk

Adverse event: Injection Site Reaction Not Otherwise Specified
Serious: no
Organ System: General disorders
Frequency: 4 affected / 199 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 199 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 5 affected / 199 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 199 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 199 at risk

Adverse event: Viral Infection Not Otherwise Specified
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 199 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 199 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk