Study: NCT00308061

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anorectal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ataxia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Bradypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 20 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 20 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 20 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 20 at risk

Adverse event: Inflammation at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 20 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 20 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus ocular
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 20 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Site mass at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 20 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Thirst
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tooth caries aggrevated
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vision accomodation abnormal
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk

Adverse event: Tubal ectopic pregnancy (right side)
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Immunization 3
Frequency: 1 affected / 20 at risk

Adverse event: Sinusitus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Immunization 2
Frequency: 1 affected / 20 at risk

Adverse event: Arm motion limitation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 20 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Glossitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

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

Adverse event: Haemorrhoids
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 20 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 20 at risk

Adverse event: Inflammation at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 20 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 20 at risk

Adverse event: Lacrimation disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

Adverse event: Malaria
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 20 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pterygium
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 20 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk