Study: NCT01535040

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 57 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 57 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 57 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 57 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 57 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 33 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 57 at risk

Adverse event: Renal and Urinary Disorder - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 13 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Liver Dysfunction / Failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 59 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 59 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 59 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 59 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 59 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 59 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 59 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 59 at risk

Adverse event: Renal and Urinary Disorder - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 59 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 8 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 59 at risk