Study: NCT00452868

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ataxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Personality/behavioral
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 11 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 11 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Occular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Speech Impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mood Alteration: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hemorrhag, pulmonary/upper respiratory: nose
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Incontenence, anal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Muscle weakness, generalized: whole body
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection with unknown ANC: Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection with unknown ANC: Nerv-peripheral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection with unknown ANC: Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Muscle weakness, generalid or specfic ara (not due to neuropathy): Left sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neuropathy: cranial: CN VIII Hearing and balance
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk