Study: NCT00647348

Adverse event: Grade 3 relapse (requiring hospital admission)
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Relapse
Serious: no
Organ System: Nervous system disorders
Notes: relapse of MS
Frequency: 17 affected / 70 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Nervous system disorders
Notes: cramp
Frequency: 12 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: headache
Frequency: 3 affected / 70 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: pain
Frequency: 7 affected / 70 at risk

Adverse event: worsening mobility
Serious: no
Organ System: Nervous system disorders
Notes: worsening mobility
Frequency: 9 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: UTI
Frequency: 9 affected / 70 at risk

Adverse event: Grade 3 relapse (requiring hospital admission)
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 70 at risk

Adverse event: Abdominal Lesion Biopsy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 70 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Increased spasticity
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Sub-arachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 70 at risk

Adverse event: Relapse
Serious: no
Organ System: Nervous system disorders
Notes: relapse of MS
Frequency: 17 affected / 70 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Nervous system disorders
Notes: cramp
Frequency: 10 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: headache
Frequency: 10 affected / 70 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: pain
Frequency: 13 affected / 70 at risk

Adverse event: worsening mobility
Serious: no
Organ System: Nervous system disorders
Notes: worsening mobility
Frequency: 8 affected / 70 at risk

Adverse event: increase spasticity
Serious: no
Organ System: Nervous system disorders
Notes: spasticity
Frequency: 7 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: UTI
Frequency: 8 affected / 70 at risk