Study: NCT00885755

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 33 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 33 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 33 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 33 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 33 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 11 affected / 33 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 33 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 33 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 33 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 33 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 33 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 33 at risk

Adverse event: Palmer-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 33 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 33 at risk

Adverse event: Scab
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 33 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 33 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 33 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Onycholsis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 33 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 33 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 33 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 33 at risk

Adverse event: Neurotoxicity
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 33 at risk

Adverse event: Polyneuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 33 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 33 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 33 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 33 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 33 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 33 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 33 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 33 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 33 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 33 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Nail bed infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 33 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 33 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 33 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 33 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 33 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 33 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 33 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 33 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 33 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 33 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 33 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 33 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 33 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 33 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 33 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 33 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 33 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 33 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 33 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 33 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 33 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 33 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 33 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 33 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 33 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 33 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 33 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk