Study: NCT02918370

Adverse event: Restlessness/Fidgeting
Serious: no
Organ System: General disorders
Frequency: 11 affected / 36 at risk

Adverse event: Increased urinary frequency or difficulty
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 36 at risk

Adverse event: increased appetite or weight gain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: dizziness or lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: increased glucose
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A participant receiving a placebo was hospitalized with high glucose levels. The diagnosis was that pre-diabetes may have progressed to diabetes. Follow-up for further assessment was arranged after discharge.
Frequency: 1 affected / 39 at risk

Adverse event: Flare up of multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Notes: Participant receiving placebo had a flare up of multiple sclerosis requiring hospitalization.
Frequency: 1 affected / 39 at risk

Adverse event: Restlessness/Fidgeting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Increased urinary frequency or difficulty
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 39 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: erectile dysfunction or decreased libido
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: increased appetite or weight gain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: dizziness or lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk