Study: NCT00624923

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 127 at risk

Adverse event: Vascular
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 127 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 127 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 127 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 127 at risk

Adverse event: Hepatobiliary
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 127 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Dermatologic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 127 at risk

Adverse event: Ear and Labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 35 affected / 127 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 17 affected / 127 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 127 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 127 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 127 at risk

Adverse event: Mouth sores
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 127 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 124 at risk

Adverse event: Vascular
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 124 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 124 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 124 at risk

Adverse event: Hepatobiliary
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 124 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 124 at risk

Adverse event: Ear and Labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 124 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 13 affected / 124 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 124 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 124 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 124 at risk

Adverse event: Mouth sores
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 124 at risk