Study: NCT01570036

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 109 affected / 136 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 49 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 95 affected / 136 at risk

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 81 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 9 affected / 136 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Dermatitis bullous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 3 affected / 136 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 4 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 5 affected / 136 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Chelitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 3 affected / 136 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local
Frequency: 10 affected / 136 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local
Frequency: 2 affected / 136 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Eyelid function disorder
Serious: no
Organ System: Eye disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Surgical and medical procedures
Notes: Local
Frequency: 4 affected / 136 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Local
Frequency: 1 affected / 136 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 70 affected / 136 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 30 affected / 136 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 29 affected / 136 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 23 affected / 136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 14 affected / 136 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 11 affected / 136 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 5 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 14 affected / 136 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 6 affected / 136 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 6 affected / 136 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 5 affected / 136 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Nail ridging
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Eythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 53 affected / 136 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 48 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 38 affected / 136 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 22 affected / 136 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 12 affected / 136 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Soft tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 57 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 13 affected / 136 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 7 affected / 136 at risk

Adverse event: Dysguesia
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Trigeminal nerve disorder
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 38 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 8 affected / 136 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 25 affected / 136 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 8 affected / 136 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 9 affected / 136 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 6 affected / 136 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Large intestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 14 affected / 136 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 15 affected / 136 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 11 affected / 136 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 12 affected / 136 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 5 affected / 136 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Laryngeal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 5 affected / 136 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 12 affected / 136 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 9 affected / 136 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 6 affected / 136 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 16 affected / 136 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 9 affected / 136 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 7 affected / 136 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Superficial vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Spinal fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Radiation recall reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 11 affected / 136 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 7 affected / 136 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 3 affected / 136 at risk

Adverse event: Right ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Aortic valve disease
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 5 affected / 136 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 5 affected / 136 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Systemic
Frequency: 7 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Systemic
Frequency: 5 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Surgical and medical procedures
Notes: Systemic
Frequency: 4 affected / 136 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Systemic
Frequency: 2 affected / 136 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Other, specify
Serious: no
Organ System: Endocrine disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: Systemic
Frequency: 1 affected / 136 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Oesophageal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 102 affected / 139 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 32 affected / 139 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 89 affected / 139 at risk

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 67 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 10 affected / 139 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 3 affected / 139 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 3 affected / 139 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 8 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 6 affected / 139 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 4 affected / 139 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Gastrointestinal disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 3 affected / 139 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Breast pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Local
Frequency: 10 affected / 139 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Eye disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Surgical and medical procedures
Notes: Local
Frequency: 2 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Local
Frequency: 1 affected / 139 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 69 affected / 139 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 28 affected / 139 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 29 affected / 139 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 26 affected / 139 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 15 affected / 139 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 7 affected / 139 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 6 affected / 139 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Gait distrubance
Serious: no
Organ System: General disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 10 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 10 affected / 139 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Nail ridging
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 41 affected / 139 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 39 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 39 affected / 139 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 21 affected / 139 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 13 affected / 139 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Osteonecrosis of jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Exostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 57 affected / 139 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 17 affected / 139 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 5 affected / 139 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 8 affected / 139 at risk

Adverse event: Dysguesia
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Vasovagal reactions
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Radiculopathy
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 38 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 16 affected / 139 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 7 affected / 139 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 10 affected / 139 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 7 affected / 139 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 7 affected / 139 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 6 affected / 139 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Oesophageal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 14 affected / 139 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 18 affected / 139 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 12 affected / 139 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 15 affected / 139 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 5 affected / 139 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Sinus disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 9 affected / 139 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 7 affected / 139 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 5 affected / 139 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 18 affected / 139 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 7 affected / 139 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 7 affected / 139 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 6 affected / 139 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 5 affected / 139 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Chloesterol high
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Spinal fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 11 affected / 139 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 8 affected / 139 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 5 affected / 139 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 5 affected / 139 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Conjuctivitis
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 6 affected / 139 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Right ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 3 affected / 139 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 2 affected / 139 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Systemic
Frequency: 6 affected / 139 at risk

Adverse event: Autoimmune disorder
Serious: no
Organ System: Immune system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Systemic
Frequency: 5 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Surgical and medical procedures
Notes: Systemic
Frequency: 4 affected / 139 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk

Adverse event: Other, specify
Serious: no
Organ System: Hepatobiliary disorders
Notes: Systemic
Frequency: 1 affected / 139 at risk