Study: NCT00834652

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 104 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 104 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 104 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 104 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 104 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 104 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 104 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 104 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 104 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 104 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 104 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 104 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 104 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 104 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 18 affected / 104 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 104 at risk

Adverse event: Skin Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 104 at risk

Adverse event: Change in Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 104 at risk

Adverse event: Syncopal episode leading to inpatient hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant (pt) seen in ER- had a syncopal episode and fell at home. Later possible persecutory delusions \& hyper-religiosity symptoms questioned; pt found walking "aimlessly" in traffic- transferred to psychiatric unit for admission and evaluation.
Frequency: 1 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 102 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 102 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 102 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 102 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 102 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 102 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 102 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 102 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 102 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 102 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 102 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 102 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 13 affected / 102 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 102 at risk

Adverse event: Skin Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 102 at risk

Adverse event: Change in Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 102 at risk