Study: NCT00616421

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 351 at risk

Adverse event: Parvovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 351 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 351 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 151 affected / 351 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 131 affected / 351 at risk

Adverse event: irritablility
Serious: no
Organ System: General disorders
Frequency: 98 affected / 351 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 82 affected / 351 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 351 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 351 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 351 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 351 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 31 affected / 351 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 351 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 351 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 351 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 351 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 693 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 693 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 693 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 693 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 693 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 226 affected / 693 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 186 affected / 693 at risk

Adverse event: irritablility
Serious: no
Organ System: General disorders
Frequency: 147 affected / 693 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 126 affected / 693 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 109 affected / 693 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 693 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 693 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 693 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 33 affected / 693 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 693 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 693 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 693 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 693 at risk

Adverse event: Shigella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 582 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 582 at risk

Adverse event: Adrenal haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 582 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 582 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 582 at risk

Adverse event: Pulmonary contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 582 at risk

Adverse event: Traumatic lung injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 582 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 582 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 582 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 582 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 226 affected / 582 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 164 affected / 582 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 97 affected / 582 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 105 affected / 582 at risk

Adverse event: mailaise
Serious: no
Organ System: General disorders
Frequency: 82 affected / 582 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 582 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 28 affected / 582 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 582 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 582 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 582 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 582 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 30 affected / 582 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 62 affected / 582 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 684 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 684 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 684 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 684 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 684 at risk

Adverse event: Skin abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 684 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 684 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 241 affected / 684 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 170 affected / 684 at risk

Adverse event: irritablility
Serious: no
Organ System: General disorders
Frequency: 152 affected / 684 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 126 affected / 684 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 126 affected / 684 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 684 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 69 affected / 684 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 684 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 35 affected / 684 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 684 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 684 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 684 at risk

Adverse event: Mouth cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 571 at risk

Adverse event: Psychiatric symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 571 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 571 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 256 affected / 571 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 126 affected / 571 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 73 affected / 571 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 79 affected / 571 at risk

Adverse event: mailaise
Serious: no
Organ System: General disorders
Frequency: 62 affected / 571 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 571 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 21 affected / 571 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 571 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 571 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 571 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 571 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 26 affected / 571 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 571 at risk