Study: NCT00858403

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3 - unlikely to be related
Frequency: 1 affected / 7 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Death Due to Disease Progression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 5 - unlikely to be related
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 - probably related
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3 - probably related
Frequency: 1 affected / 7 at risk

Adverse event: Fever in absence of neutropenia
Serious: yes
Organ System: General disorders
Notes: Grade 2 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Abdomen Pain
Serious: no
Organ System: General disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Grade 1 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 7 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - related
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 - related
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - probably related
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2 - related
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnea - With Exertion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 2 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Edema - Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2 - probably related
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 - probably related
Frequency: 1 affected / 1 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 7 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Hemoglobin - Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 - probably related
Frequency: 1 affected / 7 at risk

Adverse event: Hemorrhage - Hemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Grade 2 - unrelated
Frequency: 1 affected / 7 at risk

Adverse event: Nausea - Intermittent
Serious: no
Organ System: General disorders
Notes: Grade 1 - probably related
Frequency: 1 affected / 7 at risk

Adverse event: Nausea - Intermittent
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 - possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Pleural Effusion - Intermittent
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2 - related
Frequency: 1 affected / 7 at risk

Adverse event: Voice Hoarseness
Serious: no
Organ System: General disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting - Intermittent
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 - possibly related
Frequency: 1 affected / 7 at risk