Study: NCT00586339

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: up to Month 12
Frequency: 1 affected / 61 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: up to Month 12
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: up to Month 12
Frequency: 1 affected / 61 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 52 affected / 61 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 19 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 61 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Acute stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 61 at risk

Adverse event: Axillary mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 61 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 61 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 61 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 61 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Measles
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 61 at risk

Adverse event: Nasal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 61 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 61 at risk

Adverse event: Vulvovaginal human papilloma virus infection
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 61 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: up to Month 12
Frequency: 1 affected / 59 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: up to Month 12
Frequency: 1 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 59 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 59 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 59 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 59 at risk

Adverse event: Bartholin's abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 59 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 59 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 59 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 59 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 59 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 59 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 59 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 59 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 59 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 59 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 59 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 59 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 59 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Sexually transmitted disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Stab wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 59 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 59 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 59 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: up to Month 12
Frequency: 1 affected / 30 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: up to Month 12
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 28 affected / 30 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 30 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk