Study: NCT00512070

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abnormal lab values
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Psychotic symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abnormal lab values
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Abnormal lab values
Serious: no
Organ System: General disorders
Frequency: 5 affected / 17 at risk

Adverse event: Psychotic symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 3 affected / 17 at risk

Adverse event: Anxiety/Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 17 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Insomnia/sleep disturbance
Serious: no
Organ System: General disorders
Frequency: 4 affected / 17 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Restless leg
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk