Study: NCT02515773

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 579 at risk

Adverse event: refractory headaches
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 579 at risk

Adverse event: complications of tonsillectomy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 579 at risk

Adverse event: neck dystonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 579 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 579 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 579 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 56 affected / 558 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 20 affected / 558 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 24 affected / 558 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 14 affected / 558 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 558 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 558 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 105 affected / 558 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 558 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 558 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 558 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 720 at risk

Adverse event: complications of tonsillectomy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 720 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 720 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 720 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 720 at risk

Adverse event: urethral/kidney stone
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 720 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 720 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 720 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 720 at risk

Adverse event: fractures due to motor vehicle accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 720 at risk

Adverse event: Thyroidectomy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 720 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 720 at risk

Adverse event: sickle-cell crisis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 720 at risk

Adverse event: Sydenham's chorea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 720 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 91 affected / 686 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 41 affected / 686 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 31 affected / 686 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 20 affected / 686 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 686 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 686 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 686 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 686 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 686 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 686 at risk