Study: NCT03372460

Adverse event: Exacerbation of chronic gastrointestinal illness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pain of skin
Serious: no
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 26 at risk

Adverse event: Burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 26 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 26 at risk

Adverse event: Ringing or buzzing in ears
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Change in mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 26 at risk

Adverse event: Changes in concentration
Serious: no
Organ System: General disorders
Frequency: 8 affected / 26 at risk

Adverse event: Sleepy, drowsy, or fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 26 at risk

Adverse event: Flickering lights
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Dizziness or lightheadedness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Syncopal episode
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Treatment-emergent suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 28 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pain of skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 28 at risk

Adverse event: Burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 28 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 28 at risk

Adverse event: Ringing or buzzing in ears
Serious: no
Organ System: General disorders
Frequency: 8 affected / 28 at risk

Adverse event: Change in mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 28 at risk

Adverse event: Changes in concentration
Serious: no
Organ System: General disorders
Frequency: 12 affected / 28 at risk

Adverse event: Sleepy, drowsy, or fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 28 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 7 affected / 28 at risk

Adverse event: Dizziness or lightheadedness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 28 at risk