Study: NCT01453569

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Medication-related AE
Frequency: 1 affected / 86 at risk

Adverse event: Reproductive system and mammary gland
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Medication-related AE
Frequency: 1 affected / 86 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Medication-related AE
Frequency: 1 affected / 86 at risk

Adverse event: Behavioral and psychiatric symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 84 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 84 at risk

Adverse event: Implantation of artificial heart pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Compressive fracture of vertebra
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Ear and labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Medication-related AE
Frequency: 1 affected / 84 at risk

Adverse event: Injuries, toxicosis, complications due to surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Medication-related AE
Frequency: 1 affected / 84 at risk

Adverse event: Muscular and connective tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Medication-related AE
Frequency: 1 affected / 84 at risk

Adverse event: CNS disorders
Serious: no
Organ System: Nervous system disorders
Notes: Medication-related AE
Frequency: 1 affected / 84 at risk

Adverse event: Psychiatiric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Medication-related AE
Frequency: 5 affected / 84 at risk

Adverse event: Respiratoty system, chest and mediastinum
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Medication-related AE
Frequency: 1 affected / 84 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Medication-related AE
Frequency: 2 affected / 84 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 85 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Paralysis of oculomotor nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Emptying disorder of intestine and stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Chill
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 85 at risk

Adverse event: Ear and labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Medication-related AE
Frequency: 1 affected / 85 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Medication-related AE
Frequency: 4 affected / 85 at risk