Study: NCT00686777

Adverse event: Meningocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 75 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Labyrinthitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Cerebral ventricle dilatation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 75 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 75 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 75 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 75 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 75 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 75 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 75 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 75 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 75 at risk

Adverse event: Abnormal sensation in eye
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 75 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 75 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 75 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 75 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 75 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 75 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 75 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 75 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 75 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 75 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 75 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 75 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 75 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 75 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 11 affected / 75 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 75 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 7 affected / 75 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 30 affected / 75 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 26 affected / 75 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 11 affected / 75 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 66 affected / 75 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 75 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 73 affected / 75 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 10 affected / 75 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 75 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 75 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 75 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 75 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 75 at risk

Adverse event: Basophil count increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 75 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 75 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 75 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 75 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 75 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 75 at risk

Adverse event: Blood thyroid stimulating hormone decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 75 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 75 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 75 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 75 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 75 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 58 affected / 75 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 58 affected / 75 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 71 affected / 75 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 75 at risk

Adverse event: Monocyte count increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 75 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 69 affected / 75 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 75 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 75 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 59 affected / 75 at risk

Adverse event: Reticulocyte percentage decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 75 at risk

Adverse event: Reticulocyte percentage increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 75 at risk

Adverse event: Thyroxine free decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 75 at risk

Adverse event: Tri-iodothyronine free decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 75 at risk

Adverse event: Tri-iodothyronine free increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 75 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 75 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 73 affected / 75 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 75 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 75 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 75 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 75 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 75 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 75 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 75 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 75 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 75 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 75 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 75 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 75 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 75 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 75 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 75 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 75 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 75 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 75 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 75 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 75 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 75 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 75 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 75 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 75 at risk