Study: NCT02274948

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 166 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 166 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 166 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 166 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 166 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non speciifc diffuse pain
Frequency: 7 affected / 166 at risk

Adverse event: Gastro oesophageal reflux like symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mainly complained of heart burn and epigastric pain
Frequency: 2 affected / 166 at risk

Adverse event: Sleepyness
Serious: no
Organ System: Nervous system disorders
Notes: Its not a true CNS maniestation but probably could be due to low sugar levels or part of headache where children are not clearly express
Frequency: 1 affected / 166 at risk

Adverse event: Faintishness
Serious: no
Organ System: Nervous system disorders
Notes: This could be due to hypoglycaemic symptoms, but children may not be able to distinguish and express vertigo even.

Non had fainted
Frequency: 11 affected / 166 at risk

Adverse event: Calf Cramp
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 173 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 173 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 173 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 173 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 173 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non speciifc diffuse pain
Frequency: 4 affected / 173 at risk

Adverse event: Gastro oesophageal reflux like symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mainly complained of heart burn and epigastric pain
Frequency: 2 affected / 173 at risk

Adverse event: Sleepyness
Serious: no
Organ System: Nervous system disorders
Notes: Its not a true CNS maniestation but probably could be due to low sugar levels or part of headache where children are not clearly express
Frequency: 3 affected / 173 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Notes: Probably due to hypoglycaemia state but children many not be able to express clearly them
Frequency: 2 affected / 173 at risk

Adverse event: Faintishness
Serious: no
Organ System: Nervous system disorders
Notes: This could be due to hypoglycaemic symptoms, but children may not be able to distinguish and express vertigo even.

Non had fainted
Frequency: 5 affected / 173 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 173 at risk