Study: NCT00148317

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 4 affected / 38 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: DOVED consolidation phase
Frequency: 22 affected / 38 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: DOVED consolidation phase
Frequency: 6 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: DOVED consolidation phase
Frequency: 5 affected / 38 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: DOVED consolidation phase
Frequency: 12 affected / 38 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: DOVED consolidation phase
Frequency: 4 affected / 38 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: DOVED consolidation phase
Frequency: 6 affected / 38 at risk

Adverse event: hearing impariment
Serious: no
Organ System: Ear and labyrinth disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: DOVED consolidation phase
Frequency: 13 affected / 38 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Myopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: DOVED consolidation phase
Frequency: 5 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: DOVED consolidation phase
Frequency: 4 affected / 38 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: DOVED consolidation phase
Frequency: 7 affected / 38 at risk

Adverse event: cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: DOVED consolidation phase
Frequency: 7 affected / 38 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 24 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: DOVED consolidation phase
Frequency: 13 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 6 affected / 38 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Notes: DOVED consolidation phase
Frequency: 5 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: mobilization phase
Frequency: 2 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: mobilization phase
Frequency: 6 affected / 38 at risk

Adverse event: peripheral neuropathy (sensory)
Serious: no
Organ System: Nervous system disorders
Notes: mobilization phase
Frequency: 6 affected / 38 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: mobilization phase
Frequency: 2 affected / 38 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: mobilization phase
Frequency: 2 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: mobilization phase
Frequency: 3 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Notes: mobilization phase
Frequency: 3 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: mobilization phase
Frequency: 2 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: mobilization phase
Frequency: 7 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: mobilization phase
Frequency: 3 affected / 38 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: mobilization phase
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: mobilization phase
Frequency: 2 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: DOVED consolidation phase
Frequency: 6 affected / 38 at risk

Adverse event: afebrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: DOVED consolidation phase
Frequency: 5 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: DOVED consolidation phase
Frequency: 9 affected / 38 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: DOVED consolidation phase
Frequency: 6 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: DOVED consolidation phase
Frequency: 5 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: DOVED consolidation phase
Frequency: 15 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: DOVED consolidation phase
Frequency: 5 affected / 38 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: DOVED consolidation phase
Frequency: 2 affected / 38 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: DOVED consolidation phase
Frequency: 3 affected / 38 at risk

Adverse event: peripheral neuropathy (sensory)
Serious: no
Organ System: Nervous system disorders
Notes: DOVED consolidation phase
Frequency: 28 affected / 38 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Nervous system disorders
Notes: DOVED consolidation phase
Frequency: 7 affected / 38 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: DOVED consolidation phase
Frequency: 10 affected / 38 at risk