Study: NCT01031836

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 2 affected / 5 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 3 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 3 affected / 3 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 3 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 3 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 3 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 3 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 3 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage I
Frequency: 2 affected / 5 at risk

Adverse event: Cervix carcinoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 4 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Study Period: Stage I
Frequency: 2 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 1 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 1 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 1 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 1 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Cerebral infaraction
Serious: yes
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 3 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage I
Frequency: 3 affected / 5 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 2 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 2 affected / 4 at risk

Adverse event: Splenic infarction
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Dental caries
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Budd-Chiari syndrome
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 3 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 3 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 2 affected / 4 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 2 affected / 4 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 4 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 4 affected / 5 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 2 affected / 5 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 5 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage II
Frequency: 2 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage II
Frequency: 2 affected / 5 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Auditory disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Prinzmetal angina
Serious: yes
Organ System: Cardiac disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 2 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Study Period: Stage I
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 3 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 2 affected / 4 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study Period: Stage II
Frequency: 2 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Study Period: Stage II
Frequency: 1 affected / 4 at risk