Study: NCT00397631

Adverse event: Any Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 261 at risk

Adverse event: Acute vestibular syndrome
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 261 at risk

Adverse event: Any Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Any Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Any Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Any Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 261 at risk

Adverse event: Impulsive behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 261 at risk

Adverse event: Any Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pustular psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Any Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 261 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 261 at risk

Adverse event: Any Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 261 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 261 at risk

Adverse event: Any Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Any Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Any Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 259 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 259 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 259 at risk

Adverse event: Any Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 259 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 259 at risk

Adverse event: Any Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 259 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 259 at risk

Adverse event: Any Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 259 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 259 at risk