Study: NCT01347073

Adverse event: Hyperammonaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 23 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Chemical burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 23 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 23 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 23 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 23 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 23 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: Hyperammonaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 23 at risk

Adverse event: Hypophagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hyporeflexia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 23 at risk

Adverse event: Skin odour abnormal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk