Study: NCT02002884

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 87 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 87 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 87 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 176 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 176 at risk

Adverse event: Shunt malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 331 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 331 at risk

Adverse event: CSF shunt operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 331 at risk

Adverse event: Electroencephalogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 331 at risk

Adverse event: Spinal cord neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 331 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 331 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 331 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 331 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 331 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 331 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 331 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 331 at risk

Adverse event: Cyclic vomiting syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 331 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 331 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 331 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 331 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 331 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 331 at risk