Study: NCT01097395

Adverse event: Hemoglobin < 8.5 g/dL
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Frozen arms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hemoglobin < 10 g/dL
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 17 at risk

Adverse event: ANC < 1000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 17 at risk

Adverse event: Platelets < 75,000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 17 at risk

Adverse event: WBC <2000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 3 Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Grade 3 Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 3 Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 3 Mood Alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 3 Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Grade 3 Shortness of Breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Hemoglobin < 8.5 g/dL
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Tooth pain and vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Astrocytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Mood alteration
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemoglobin < 10 g/dL
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 18 at risk

Adverse event: ANC < 1000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 18 at risk

Adverse event: Platelets < 75,000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: WBC <2000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Grade 3 Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Grade 3 Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Grade 3 Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Grade 3 Shortness of Breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk