Study: NCT01106950

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Blood disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 15 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hematologic toxicity - ANC<500
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Typhilitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 3 affected / 15 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Fungal pneumonia
Frequency: 1 affected / 15 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: Possible fungal emboli
Frequency: 1 affected / 15 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Notes: CMV encephalitis and viremia
Frequency: 1 affected / 15 at risk

Adverse event: Infections and infestations- other
Serious: yes
Organ System: Infections and infestations
Notes: HHV6 positive bone marrow and blood cultures
Frequency: 1 affected / 15 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Acute kidney injury - grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 15 at risk

Adverse event: Acute kidney injury - grade 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 15 at risk

Adverse event: Acute kidney injury - grade 3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 15 at risk

Adverse event: Diffuse alveolar hemorrhage - grade 5
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Gum/jaw pain - grade 2
Serious: no
Organ System: General disorders
Frequency: 4 affected / 15 at risk

Adverse event: Autoimmune disorder - grade 1
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 15 at risk

Adverse event: Autoimmune disorder - grade 2
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Autoimmune disorder - grade 3
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 15 at risk

Adverse event: Confusion - grade 4
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chills - grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 15 at risk

Adverse event: Chills - grade 2
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 15 at risk

Adverse event: Chills - grade 3
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 15 at risk

Adverse event: Dyspnea - grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 15 at risk

Adverse event: Dyspnea - grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Dyspnea - grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Dyspnea - grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Dyspnea - grade 5
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Edema - grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 15 at risk

Adverse event: Edema - grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 15 at risk

Adverse event: Edema - grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 15 at risk

Adverse event: Edema - grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Headache - grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypoxia - grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 15 at risk

Adverse event: Hypoxia - grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Hypoxia - grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 15 at risk

Adverse event: Hypoxia - grade 5
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Hypertension - grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 15 at risk

Adverse event: Hypertension - grade 2
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 15 at risk

Adverse event: Hypertension - grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 15 at risk

Adverse event: Hypertension - grade 4
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 15 at risk

Adverse event: Hypotension - grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 15 at risk

Adverse event: Hypotension - grade 2
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 15 at risk

Adverse event: Hypotension - grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 15 at risk

Adverse event: Hypotension - grade 4
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 15 at risk

Adverse event: Infusion related reaction - grade 1
Serious: no
Organ System: Investigations
Frequency: 15 affected / 15 at risk

Adverse event: Infusion related reaction - grade 2
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: Infusion related reaction - grade 3
Serious: no
Organ System: Investigations
Frequency: 4 affected / 15 at risk

Adverse event: Fever - grade 1
Serious: no
Organ System: General disorders
Frequency: 15 affected / 15 at risk

Adverse event: Fever - grade 2
Serious: no
Organ System: General disorders
Frequency: 4 affected / 15 at risk

Adverse event: Fever - grade 3
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Fever - grade 4
Serious: no
Organ System: General disorders
Frequency: 15 affected / 15 at risk

Adverse event: Pneumonitis/pulmonary infiltrates - grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 15 at risk

Adverse event: Pneumonitis/pulmonary infiltrates - grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 15 at risk

Adverse event: Pneumonitis/pulmonary infiltrates - grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonitis/pulmonary infiltrates - grade 5
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Rash/desquamation - grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 15 at risk

Adverse event: Rash/desquamation - grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: Rash/desquamation - grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: Rash/desquamation - grade 4
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal distension - grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Bruising - grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chest pain - grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Blood disorder - grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Adult respiratory distress syndrome - grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Autoimmune disorder - grade 4
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Confusion - grade 3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Emesis - grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Heart failure - grade 4
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache - grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache - grade 4
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonitis/pulmonary infiltrates - grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Febrile neutropenia - grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Left ventricular systolic dysfunction - grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonitis - grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Intracranial hemorrhage - grade 2
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lung infection - grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased creatinine - grade 2
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased creatinine - grade 3
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk