Study: NCT01921387

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 3 affected / 20 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 5 affected / 20 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 13 affected / 20 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 20 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 2 affected / 20 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 2 and Grade 4
Frequency: 2 affected / 20 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 and Grade 4
Frequency: 2 affected / 20 at risk

Adverse event: Engraftment syndrome
Serious: yes
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Blood infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 20 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 15 affected / 20 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 20 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 3 affected / 20 at risk

Adverse event: Serum sickness
Serious: yes
Organ System: Immune system disorders
Notes: Grade 3
Frequency: 2 affected / 20 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 2 affected / 20 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 20 at risk