Study: NCT01032200

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Optic nerve disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: Photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 26 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 26 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 26 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 26 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Eye Disorders - Other
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 26 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 26 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Rash Masculo-Papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 26 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Agitation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Delirium
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Infections and Infestations - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Muscle Weakness - left-sided
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Muscle Weakness - lower limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Personality change
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 27 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Ear and Labyrinth - Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 27 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 27 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 27 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 27 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 27 at risk