Study: NCT01601535

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Pharyngeal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Oral dysaesthesia
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: no
Organ System: Surgical and medical procedures
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Metabolism and nutrition disorders - Other, specify
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 6 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 6 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: no
Organ System: Surgical and medical procedures
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 4 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 4 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 4 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 4 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 4 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 4 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 4 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 4 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 19 affected / 20 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 20 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 20 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 18 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 18 affected / 20 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 17 affected / 20 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 20 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 20 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 18 affected / 20 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 20 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 17 affected / 20 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 20 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 17 affected / 20 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 20 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 20 affected / 20 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 20 affected / 20 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 20 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 20 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 9 affected / 20 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 11 affected / 20 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 11 affected / 20 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 20 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 20 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 20 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 20 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 9 affected / 20 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 20 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Psychiatric disorders - Other, specify
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 7 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 20 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 20 at risk

Adverse event: Pharyngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 20 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 20 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 20 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 12 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 9 affected / 12 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 9 affected / 12 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 11 affected / 12 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 12 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 12 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 12 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 12 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 12 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 12 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 12 affected / 12 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 10 affected / 12 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 12 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 11 affected / 12 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 12 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 12 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 12 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 12 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 8 affected / 12 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 12 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 12 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 12 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 12 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 6 affected / 12 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 3 affected / 12 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 5 affected / 12 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 12 at risk

Adverse event: Dermatitis bullous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 4 affected / 12 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 2 affected / 12 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: As requested, we are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.
Frequency: 1 affected / 12 at risk