Study: NCT00093470

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 72 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 29 affected / 72 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 25 affected / 72 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 36 affected / 72 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 72 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Peripheral nerve infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 72 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 72 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 72 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 72 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Eye disorders - Other, specify
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 72 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 72 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 72 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 72 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 72 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 39 affected / 72 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 72 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 72 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 72 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 69 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 69 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 69 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 69 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 69 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 69 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk