Study: NCT00292461

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 2 affected / 34 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: derived from Table for all drug-related AEs
Frequency: 2 affected / 34 at risk

Adverse event: White blood cell urine positive
Serious: no
Organ System: Investigations
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Derived from Table for all drug-related AEs
Frequency: 2 affected / 34 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Investigations
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Hepatic enzyme abnormal
Serious: no
Organ System: Investigations
Notes: Derived from Table for all drug-related AEs
Frequency: 3 affected / 34 at risk

Adverse event: Red blood cell urine positive
Serious: no
Organ System: Investigations
Notes: Derived from Table for all drug-related AEs
Frequency: 2 affected / 34 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Hepatic function disorders
Serious: no
Organ System: Hepatobiliary disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 34 at risk

Adverse event: Lumber contusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nystagmus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 2 affected / 30 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Nervous system disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 2 affected / 30 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: derived from Table for all drug-related AEs
Frequency: 2 affected / 30 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: nausia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: Contusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 2 affected / 30 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 3 affected / 30 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Derived from Table for all drug-related AEs
Frequency: 1 affected / 30 at risk