Study: NCT02246218

Adverse event: Ammonia increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Apnoeic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pneumatosis intestinalis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperammonaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 10 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Peripheral vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Stoma site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Tibia fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Amino acid level decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Ammonia increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Carbon dioxide decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Dacryostenosis congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gross motor delay
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Excessive cerumen production
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Vesicoureteric reflux
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nail ridging
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypophagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hyperammonaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 16 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Feeding disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Medical device site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Catheter site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Device occlusion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Drug withdrawal syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Medical device site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Stoma site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Amino acid level decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Ammonia increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Carbon dioxide decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Amino acid level increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Anion gap increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Blood urea decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Body height below normal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Plagiocephaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 16 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 16 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lymphocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Microcytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Use of accessory respiratory muscles
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Post-tussive vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hepatic calcification
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 16 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vancomycin infusion reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hypophagia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hyperammonaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Selective eating disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Protein deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 16 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 16 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Angular cheilitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Rhinovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk