Study: NCT01956097

Adverse event: Autonomic symptoms: palpitations/tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 30 at risk

Adverse event: Autonomic symptoms: accomodation disturbances
Serious: no
Organ System: Eye disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 30 at risk

Adverse event: Autonomic symptoms: diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Autonomic symptoms: constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 4 affected / 30 at risk

Adverse event: Autonomic symptoms: nausea/vomitting
Serious: no
Organ System: Gastrointestinal disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Other symptoms: weight gain
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 6 affected / 30 at risk

Adverse event: Other symptoms: weight loss
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 4 affected / 30 at risk

Adverse event: Other symptoms: headache
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 6 affected / 30 at risk

Adverse event: Autonomic symptoms: orthostatic dizziness
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 5 affected / 30 at risk

Adverse event: Autonomic symptoms: increased tendency to sweating
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Neurologic symptoms: rigidity
Serious: no
Organ System: Nervous system disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Neurologic symptoms: paresthesia
Serious: no
Organ System: Nervous system disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 30 at risk

Adverse event: Psychic symptoms: increased fatigability
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 11 affected / 30 at risk

Adverse event: Psychic symptoms: sleepiness/sedation
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 9 affected / 30 at risk

Adverse event: Psychic symptoms: failing memory
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 30 at risk

Adverse event: Psychic symptoms: depression
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 4 affected / 30 at risk

Adverse event: Psychic symptoms: increased duration of sleep
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Psychic symptoms: reduced duration of sleep
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 7 affected / 30 at risk

Adverse event: Psychic symptoms: increased dream activity
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 5 affected / 30 at risk

Adverse event: Autonomic symptoms: polyuria/polydipsia
Serious: no
Organ System: Renal and urinary disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Other symptoms: pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 4 affected / 30 at risk

Adverse event: Autonomic symptoms: palpitations/tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Autonomic symptoms: constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Autonomic symptoms: nausea/vomitting
Serious: no
Organ System: Gastrointestinal disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Other symptoms: weight gain
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 30 at risk

Adverse event: Other symptoms: headache
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 6 affected / 30 at risk

Adverse event: Autonomic symptoms: orthostatic dizziness
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Autonomic symptoms: increased tendency to sweating
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Autonomic symptoms: reduced salivation
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Neurologic symptoms: dystonia
Serious: no
Organ System: Nervous system disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Neurologic symptoms: rigidity
Serious: no
Organ System: Nervous system disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Psychic symptoms: increased fatigability
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 5 affected / 30 at risk

Adverse event: Psychic symptoms: sleepiness/sedation
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 30 at risk

Adverse event: Psychic symptoms: failing memory
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Psychic symptoms: depression
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Psychic symptoms: tension/inner unrest
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 30 at risk

Adverse event: Psychic symptoms: increased duration of sleep
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Psychic symptoms: reduced duration of sleep
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Psychic symptoms: increased dream activity
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Autonomic symptoms: polyuria/polydipsia
Serious: no
Organ System: Renal and urinary disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 4 affected / 30 at risk

Adverse event: Other symptoms: rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 30 at risk

Adverse event: Other symptoms: morbilliform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 30 at risk

Adverse event: Other symptoms: pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 7 affected / 30 at risk

Adverse event: Autonomic symptoms: palpitations/tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Autonomic symptoms: accomodation disturbances
Serious: no
Organ System: Eye disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Autonomic symptoms: diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Autonomic symptoms: nausea/vomitting
Serious: no
Organ System: Gastrointestinal disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Other symptoms: weight loss
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Other symptoms: headache
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 5 affected / 15 at risk

Adverse event: Autonomic symptoms: orthostatic dizziness
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Autonomic symptoms: increased tendency to sweating
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Autonomic symptoms: reduced salivation
Serious: no
Organ System: General disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Neurologic symptoms: dystonia
Serious: no
Organ System: Nervous system disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Neurologic symptoms: rigidity
Serious: no
Organ System: Nervous system disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Neurologic symptoms: paresthesia
Serious: no
Organ System: Nervous system disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Psychic symptoms: increased fatigability
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 4 affected / 15 at risk

Adverse event: Psychic symptoms: sleepiness/sedation
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Psychic symptoms: failing memory
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Psychic symptoms: depression
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 3 affected / 15 at risk

Adverse event: Psychic symptoms: tension/inner unrest
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Psychic symptoms: increased duration of sleep
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Psychic symptoms: reduced duration of sleep
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Psychic symptoms: increased dream activity
Serious: no
Organ System: Psychiatric disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Autonomic symptoms: micturition disturbances
Serious: no
Organ System: Renal and urinary disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Autonomic symptoms: polyuria/polydipsia
Serious: no
Organ System: Renal and urinary disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Other symptoms: increased sexual desire
Serious: no
Organ System: Reproductive system and breast disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Other symptoms: rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk

Adverse event: Other symptoms: morbilliform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Other symptoms: cannot be classified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 1 affected / 15 at risk

Adverse event: Other symptoms: pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any of the side effects listed in the UKU side effect rating scale
Frequency: 2 affected / 15 at risk