Study: NCT02181231

Adverse event: Hospitalization for Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 8 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 12 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 8 affected / 12 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Palpatations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Disorientation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Room spinning
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Increased body temperature
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Tinnitus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Yawning
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Urinary problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Swollen hands and ankles
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Urticaria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Increased intestinal gas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Falls
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalized for emergency cardiac catheterization and insertion of cardiac stent. Diagnosed with partially closed blood vessel due to scleroderma diagnosis.
Frequency: 1 affected / 6 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Urinary problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk