Study: NCT01664494

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 563 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 563 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 563 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 563 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 563 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 563 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 563 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 563 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 563 at risk

Adverse event: Enterocolitis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 563 at risk

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 563 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 563 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 563 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 563 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 563 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 563 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 563 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 563 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 563 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 563 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 563 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 563 at risk

Adverse event: Inflammatory marker increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 563 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 563 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 563 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 563 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 563 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 563 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 563 at risk

Adverse event: Hypertonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 563 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 563 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 563 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 563 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 563 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 563 at risk

Adverse event: Blister
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 563 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 563 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 563 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 172 affected / 563 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 563 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 563 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 563 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 563 at risk