Study: NCT00049530

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: General disorders and administration sit
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Gastrointestinal disorders - Other, spec
Serious: yes
Organ System: Gastrointestinal disorders
Notes: details were unknown (no data)
Frequency: 1 affected / 32 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Infections w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 32 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 32 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 32 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 32 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 32 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Skin and subcutaneous tissue disorders -
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 32 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 32 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 32 at risk

Adverse event: Nervous system disorders - Other, specif
Serious: no
Organ System: Nervous system disorders
Notes: details were unknown (no data)
Frequency: 2 affected / 32 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 32 at risk

Adverse event: General disorders and administration sit
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk