Study: NCT02180867

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 2 affected / 4 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Pediatric
Frequency: 1 affected / 5 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 4 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: Pediatric
Frequency: 1 affected / 3 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Pediatric
Frequency: 1 affected / 3 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Pediatric
Frequency: 1 affected / 3 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Pediatric
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 3 affected / 6 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Adult
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pediatric
Frequency: 1 affected / 3 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Pediatric
Frequency: 1 affected / 3 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Photophobia
Serious: yes
Organ System: Eye disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Skin hypopigmentation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 7 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 2 affected / 7 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Pediatric
Frequency: 2 affected / 16 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Pediatric
Frequency: 2 affected / 16 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pediatric
Frequency: 7 affected / 16 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

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

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pediatric
Frequency: 3 affected / 16 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Perforation bile duct
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

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

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

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

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Pediatric
Frequency: 1 affected / 16 at risk

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

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Notes: Adult
Frequency: 3 affected / 30 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 11 affected / 30 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 3 affected / 30 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 3 affected / 30 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 5 affected / 30 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 5 affected / 30 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 4 affected / 30 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Adult
Frequency: 4 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 4 affected / 30 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 8 affected / 30 at risk

Adverse event: Ejection fraction decreased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 30 at risk

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

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 3 affected / 16 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 4 affected / 16 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 3 affected / 16 at risk

Adverse event: Recall phenomenon
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 4 affected / 16 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: Pediatric
Frequency: 1 affected / 16 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 2 affected / 30 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 10 affected / 30 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 5 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 6 affected / 30 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adult
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Pediatric
Frequency: 1 affected / 18 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Pediatric
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 2 affected / 25 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 2 affected / 18 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 5 affected / 18 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 2 affected / 18 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Pediatric
Frequency: 3 affected / 18 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adult
Frequency: 2 affected / 25 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 1 affected / 25 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 3 affected / 25 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 2 affected / 25 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 2 affected / 25 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Adult
Frequency: 2 affected / 25 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Adult
Frequency: 1 affected / 5 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 5 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adult
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adult
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Adult
Frequency: 1 affected / 5 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adult
Frequency: 1 affected / 5 at risk