Study: NCT00401830

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 81 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 81 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 81 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 81 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 81 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 81 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 81 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 81 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 81 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 81 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 81 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 81 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 81 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 81 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 78 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 78 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 78 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 78 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 78 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 78 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 78 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 78 at risk