Study: NCT00611806

Adverse event: Hospitalization due to worsening psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Irritation of Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 94 at risk

Adverse event: Constipation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 94 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 94 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Dirrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 94 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Mania
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 94 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 94 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 94 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Irritation of Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 94 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 94 at risk

Adverse event: Hospitalization due to worsening psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Injury
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Asthema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Brain neoplasm
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 46 at risk