Study: NCT02395666

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: All Unrelated
Frequency: 8 affected / 140 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: All Unrelated
Frequency: 3 affected / 140 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: All Unrelated
Frequency: 3 affected / 140 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Benign vascular lesion
Serious: yes
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Swelling of Eye
Serious: yes
Organ System: Eye disorders
Notes: Eye swelling result of brain mass that has been confirmed as metastatic recurrent neuroblastoma.

Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Possibly related
Frequency: 1 affected / 140 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Possibly related
Frequency: 1 affected / 140 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Possibly related
Frequency: 1 affected / 140 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Femur Fracture- Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: gastric obstruction secondary to adhesions from previous surgery. Resolved after surgical correction.

Unrelated
Frequency: 1 affected / 140 at risk

Adverse event: Neutrophil count decrease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 140 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 140 at risk

Adverse event: ALT elevation
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 140 at risk

Adverse event: AST elevation
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 140 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 140 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 140 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 140 at risk