Study: NCT01838941

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea in 2 participants; duration: between 1 to 6 days.
Frequency: 2 affected / 12 at risk

Adverse event: Change in body odor (skin, urine, and/or breath)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Change in breath in 2 participants; duration: up to 6 months Change in body odor (metallic smell) in 1 participant; duration: 2 months and a half.

Change in urine odor in 2 participants; duration: 2 months.
Frequency: 3 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Dry mouth in 1 participant; duration: 1 week.
Frequency: 1 affected / 12 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Croup in 1 participant; duration: 1 day.
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue in 3 participants; duration: 2 weeks to 4 months.
Frequency: 3 affected / 12 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory tract infection in 2 participants; duration: 7 to 10 days.
Frequency: 2 affected / 12 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gas in 1 participant; duration: 6 days.
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation in 4 participants; duration: 6 to 9 days.
Frequency: 4 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting in 1 participant; duration: 11 days.
Frequency: 1 affected / 12 at risk

Adverse event: Ear infection/Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ear infection/Otitis media in 2 participants; duration: 5 days to 1 month.
Frequency: 2 affected / 12 at risk

Adverse event: Increase in seizure activity
Serious: no
Organ System: Nervous system disorders
Notes: Increase in seizure activity in 1 participant; duration: unknown
Frequency: 1 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Decreased appetite in 2 participants; duration: up to 2 months
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Upset stomach in 1 participant; duration: 1 month
Frequency: 1 affected / 12 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Viral syndrome in 3 participants; duration: approx. 5 days.
Frequency: 3 affected / 12 at risk

Adverse event: Elevated INR levels
Serious: no
Organ System: Investigations
Notes: Elevated INR levels in 1 participant
Frequency: 1 affected / 12 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: Eye discharge in 1 participant.
Frequency: 1 affected / 12 at risk

Adverse event: Febrile convulsion
Serious: no
Organ System: Nervous system disorders
Notes: Febrile seizure in 1 participant; duration: 1 day
Frequency: 1 affected / 12 at risk