Study: NCT01077258

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 4208 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 4208 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 4208 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 4208 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 4208 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 4208 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4208 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4208 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4208 at risk

Adverse event: Rash pustular
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4208 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4208 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4208 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4208 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4208 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4208 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4208 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4208 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4208 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Device-related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Furuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Genital herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Infection susceptibility increased
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Sinobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4208 at risk

Adverse event: Infection site erythema
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 4208 at risk

Adverse event: Injection site pruritus
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 4208 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 4208 at risk

Adverse event: Unevaluable event
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 4208 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 4208 at risk

Adverse event: Injection site pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Injection site swelling
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Injection site urticaria
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Condition aggravated
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Disease recurrence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Injection site induration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Injection site scab
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Mucosal dryness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Obstruction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 4208 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 4208 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 4208 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 4208 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Rash pruritic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Nail discolouration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Pustular psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Acne
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Cutaneous vasculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Dermatitis acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Lichenoid keratosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Rash generalized
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Skin discomfort
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Skin mass
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Swelling face
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 4208 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 4208 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Alveolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hypersensitivity pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Dry throat
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Throat irritation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Upper airway obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4208 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4208 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Aphthous ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Glossodynia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hypoaesthesia oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Mouth ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Oedema mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Swollen tongue
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Tongue blistering
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Tongue disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 4208 at risk

Adverse event: Joint arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 4208 at risk

Adverse event: Synovectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 4208 at risk

Adverse event: Injection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 4208 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 4208 at risk

Adverse event: Antibiotic therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Arthrodesis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Oesophageal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Mastoid operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Mastoidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Rehabilitation therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Sinus operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Stent placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Therapy cessation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Vertebroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4208 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4208 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Anosmia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hypogeusia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Neurological symptom
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4208 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4208 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4208 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4208 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4208 at risk

Adverse event: Respiratory tract haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4208 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4208 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4208 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4208 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4208 at risk

Adverse event: Wound secretion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4208 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Fasciitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Lupus-like syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4208 at risk

Adverse event: Skin papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4208 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Large intestine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Laryngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Papillary tumour of renal pelvis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Urteric cancer local
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4208 at risk

Adverse event: Eyelid oedema
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Eyelid exfoliation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Eyelids pruritus
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Xerophthalmia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Arthroscopy
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4208 at risk

Adverse event: Antinuclar antibody positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4208 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4208 at risk

Adverse event: DNA antibody positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4208 at risk

Adverse event: Electrophoresis protein abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4208 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4208 at risk

Adverse event: Transaminase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4208 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 4208 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Panic reaction
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Sleep disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Bladder tamponade
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Chromaturia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Micturition urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4208 at risk

Adverse event: Flushing
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Erectile dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4208 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4208 at risk