Study: NCT02304302

Adverse event: Signs and symptoms of upper respiratory viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 79 at risk

Adverse event: Transient dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 79 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 79 at risk

Adverse event: Mood changes or irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 79 at risk

Adverse event: Mood changes or sadness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 79 at risk

Adverse event: Oppositional or aggressive behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Weakness or fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Increase in thyroid-stimulating hormone levels
Serious: no
Organ System: Endocrine disorders
Notes: Clinically significant increase in thyroid-stimulating hormone concentrations in participant with hypothyroidism between screening and follow-up visits
Frequency: 3 affected / 79 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Increased self-talk
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 79 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 79 at risk

Adverse event: Signs and symptoms of upper respiratory viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 81 at risk

Adverse event: Transient dizziness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 81 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 81 at risk

Adverse event: Mood changes or irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 81 at risk

Adverse event: Mood changes or sadness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 81 at risk

Adverse event: Oppositional or aggressive behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 81 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 81 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 81 at risk

Adverse event: Nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 81 at risk

Adverse event: Weakness or fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 81 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 81 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 81 at risk

Adverse event: Herpes simplex flair-up
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk