Study: NCT01421017

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Breast pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Neosplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Breast pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 12 at risk

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

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 12 at risk

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

Adverse event: Skin odour abnormal
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 12 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Erythema Multiforma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 12 affected / 12 at risk

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

Adverse event: Neoplasms benign, malignant, and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 12 at risk

Adverse event: Pruitus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 12 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Adult respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 12 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 12 at risk

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Breast pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

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

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

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

Adverse event: Radiation skin injury
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 12 at risk

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

Adverse event: Dysarthria
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 12 at risk

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

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 7 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 7 at risk

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

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

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

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 7 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 7 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 7 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 7 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 7 at risk

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

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 7 at risk

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