Study: NCT01546649

Adverse event: Eyelid ptosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 83 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 83 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 83 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 83 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 83 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 36 affected / 83 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 83 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 83 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 83 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 83 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 83 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 83 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 83 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 83 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 83 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 83 at risk

Adverse event: Radiation pneumonitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 83 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 83 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 83 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 83 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 83 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 83 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 7 affected / 83 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 83 at risk

Adverse event: Bone density decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 83 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 83 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 83 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 83 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 83 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 83 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 83 at risk

Adverse event: Menopausal symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 83 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 83 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 83 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 83 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 43 affected / 83 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 83 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Faecal occult blood positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cervix carcinoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Behcet's syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 84 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 84 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 84 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 84 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 84 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 84 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 33 affected / 84 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 26 affected / 84 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 84 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 84 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 84 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 7 affected / 84 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 84 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 84 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 84 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 84 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 84 at risk

Adverse event: Radiation pneumonitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 84 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 84 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 84 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 84 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 84 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 84 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 4 affected / 84 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 84 at risk

Adverse event: Bone density decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 84 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 84 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 84 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 84 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 84 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 84 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 84 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 84 at risk

Adverse event: Menopausal symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 84 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 84 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 84 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 84 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 84 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 48 affected / 84 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 84 at risk