Study: NCT00369785

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 96 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 96 at risk

Adverse event: Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 96 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Mood Alteration: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 96 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pain: Back
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 96 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 96 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 96 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 96 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 96 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 96 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 96 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 43 affected / 96 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 96 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 96 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 96 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 96 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 96 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Auditory/Ear - Other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 92 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 92 at risk

Adverse event: Dental: peridontal disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 92 at risk

Adverse event: Dental: teeth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 92 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 92 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 92 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 92 at risk

Adverse event: Neuropathy: cranial: CN II Vision
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Neuropathy: cranial: CN VII Motor-face; Sensory-taste
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 92 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 92 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 92 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 92 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 92 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 92 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 92 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 92 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 92 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 92 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 92 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 92 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 92 at risk