Study: NCT00529555

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject was involved in a motorcycle accident on 30 April 2006 and was hospitalized.
Frequency: 1 affected / 200 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Tooth injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Cellulitis and pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Myocardial infarction and fatigue
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cellulitis of male organ external epididymitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pain and injury
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 200 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Collected in a non-specific manner
Frequency: 138 affected / 200 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Collected in a non-specific manner
Frequency: 71 affected / 200 at risk

Adverse event: Gerenal Disorders and adminstration site conditions
Serious: no
Organ System: General disorders
Notes: Collected in a non-specific manner
Frequency: 30 affected / 200 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Collected in a non-specific manner
Frequency: 44 affected / 200 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Collected in a non-specific manner
Frequency: 16 affected / 200 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Collected in a non-specific manner
Frequency: 12 affected / 200 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Collected in a non-specific manner
Frequency: 27 affected / 200 at risk

Adverse event: Death
Serious: yes
Organ System: Social circumstances
Notes: Died in a car accident
Frequency: 1 affected / 202 at risk

Adverse event: Right knee replacement surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 202 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 202 at risk

Adverse event: Cast
Serious: yes
Organ System: Social circumstances
Notes: Subject slipped on the ice in driveway. An x-ray showed a fracture of the left ankle. A cast was placed and subsequently replaced with a brace enabling the subject to walk without assistive devices.
Frequency: 1 affected / 202 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Collected in a non-specific manner
Frequency: 140 affected / 202 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Collected in a non-specific manner
Frequency: 137 affected / 202 at risk

Adverse event: Gerenal Disorders and adminstration site conditions
Serious: no
Organ System: General disorders
Notes: Collected in a non-specific manner
Frequency: 131 affected / 202 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Collected in a non-specific manner
Frequency: 41 affected / 202 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Collected in a non-specific manner
Frequency: 11 affected / 202 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Collected in a non-specific manner
Frequency: 16 affected / 202 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Collected in a non-specific manner
Frequency: 19 affected / 202 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hopsitalization for complications from Multiple Sclerosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Collected in a non-specific manner
Frequency: 134 affected / 200 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Collected in a non-specific manner
Frequency: 138 affected / 200 at risk

Adverse event: Gerenal Disorders and adminstration site conditions
Serious: no
Organ System: General disorders
Notes: Collected in a non-specific manner
Frequency: 109 affected / 200 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Collected in a non-specific manner
Frequency: 40 affected / 200 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Collected in a non-specific manner
Frequency: 16 affected / 200 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Collected in a non-specific manner
Frequency: 11 affected / 200 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Collected in a non-specific manner
Frequency: 25 affected / 200 at risk