Study: NCT00520741

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 106 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Conversion disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hallucination, visual
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 106 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 106 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 106 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 106 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 106 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 106 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 106 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 106 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 106 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 106 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 106 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 106 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 106 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 106 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 106 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 106 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 319 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Glossitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Sudden unexplained death in epilepsy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 319 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 319 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 319 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 319 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 319 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 319 at risk

Adverse event: Abnormal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 319 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 319 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 319 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 319 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 319 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 319 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 319 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 319 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 319 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 319 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 319 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 86 affected / 319 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 319 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 319 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 319 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 319 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 319 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 319 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 319 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 319 at risk