Study: NCT00620815

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 199 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 199 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 30 affected / 199 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 199 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 13 affected / 199 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 22 affected / 199 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 172 affected / 199 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 199 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 66 affected / 199 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 199 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 199 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 199 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 75 affected / 199 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 90 affected / 199 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 199 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 199 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 199 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 199 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: In subjects \>= 61 years of age.
Frequency: 2 affected / 3 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Wisdom teeth removal
Serious: no
Organ System: Surgical and medical procedures
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 88 affected / 199 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 203 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Eye operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 203 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 203 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 19 affected / 203 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 203 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 11 affected / 203 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 14 affected / 203 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 164 affected / 203 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 203 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 55 affected / 203 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 203 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 203 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 203 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 203 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 86 affected / 203 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 203 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 203 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 203 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 203 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 1 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 1 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 1 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: In subjects \>= 61 years of age.
Frequency: 1 affected / 1 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 92 affected / 203 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 198 at risk

Adverse event: Endoscopic retrograde cholangiopancreatography
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 198 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 198 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 198 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 198 at risk

Adverse event: Bulimia nervosa
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Hysterosalpingo-oophorectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Lymphadenectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 198 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 198 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 11 affected / 198 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 198 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 8 affected / 198 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 12 affected / 198 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 155 affected / 198 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 11 affected / 198 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 38 affected / 198 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 198 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 198 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 198 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 60 affected / 198 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 198 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 198 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 198 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 198 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 71 affected / 198 at risk