Study: NCT00726661

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 832 at risk

Adverse event: Bilateral subdural hematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 832 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 832 at risk

Adverse event: Coronary artery ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 832 at risk

Adverse event: Left ventricular systolic dysfunction (Grade >=2)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Left ventricular systolic dysfunction (Grade 3)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Left ventricular systolic dysfunction (Grade 4)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Recurrent transient ischemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Incarcerated umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Intractable nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Perforated diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Perforation colon (Grade 1)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Persistant vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 832 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 832 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 832 at risk

Adverse event: Hepatic insufficiency related to metastatic breast cancer
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 832 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 832 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 832 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 832 at risk

Adverse event: Infection peritioneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 832 at risk

Adverse event: Infection-left breast
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 832 at risk

Adverse event: Line associated bacteremia (vascular chest port infection)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 832 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 832 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 832 at risk

Adverse event: Severe thrush
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 832 at risk

Adverse event: Femoral neck fracture right hip
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 832 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 832 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 832 at risk

Adverse event: Hypercalcemeia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 832 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Pain musculoskeletal joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: T4 intramedullary mass
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 832 at risk

Adverse event: Cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Hemorrhagic mass in brain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Posterior reversible encephtalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 832 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 832 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 832 at risk

Adverse event: Bilateral pulmonary emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 832 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 832 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 832 at risk

Adverse event: Epistaxis (nose hemorrhage)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Left lung atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Pulmonary emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 832 at risk

Adverse event: Pulmonary embolism Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Bilateral leg ulcers
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Cellulitis of the left upper extremity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Left heel ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Arterial thromboembolic events
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Elevated blood pressure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Moderate size infarct involving a portion of the right middle cerebral artery territory
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Severe venous thromboembolic event (Grade > =4)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Thrombosis/thrombus/embolism - pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Left ventricular systolic dysfunction (Grade >=2)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 832 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Decreased ejection fraction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 832 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Bicytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Worsening anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Myelosuppression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Intermittent nosebleeds grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 832 at risk

Adverse event: Malignant pleural effusion indicating disease progression
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 832 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 832 at risk

Adverse event: Arterial thromboembolic event
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 832 at risk

Adverse event: Venous thromboembolic event (Grade > =4)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 832 at risk

Adverse event: Infusional reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 832 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 832 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 832 at risk

Adverse event: Pain-musculoskeletal-joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Nail toxicity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Bilateral hand neuropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 832 at risk

Adverse event: Peripheral neuropathy (Grade >=3)
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 832 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Peripheral neuropathy (motor or sensory) (grade >= 3)
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 832 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Sensory neuropathy grade 2
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Tingling in fingers grade I
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 832 at risk

Adverse event: Neuropathy of toes and clinical progression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 832 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 832 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 832 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 832 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Recurrent right pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 832 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 832 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 832 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 832 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 435 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 435 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 435 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 435 at risk

Adverse event: Pericardial effusion with impending tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 435 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 435 at risk

Adverse event: Hospitalization for weakness that ended in death (cause unknown)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 435 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 435 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 435 at risk

Adverse event: Intertrochanteric hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 435 at risk

Adverse event: Hypercalcemeia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 435 at risk

Adverse event: Pathologic fracture of the femur
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 435 at risk

Adverse event: Acute left occipital infarct
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 435 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 435 at risk

Adverse event: Acute pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Bilateral pulmonary emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Pulmonary embolization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 435 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 435 at risk

Adverse event: Multi-organ failure (shock)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 435 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 435 at risk

Adverse event: Left ventricular systolic dysfunction (Grade >=2)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 435 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 435 at risk

Adverse event: Venous thromboembolic event (Grade > =4)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 435 at risk

Adverse event: Infusion reaction Grade II
Serious: no
Organ System: General disorders
Frequency: 1 affected / 435 at risk

Adverse event: Osteonecrosis of the jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 435 at risk

Adverse event: Peripheral neuropathy (Grade >=3)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 435 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 435 at risk

Adverse event: Peripheral neuropathy (motor or sensory) (grade >= 3)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 435 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 435 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 435 at risk