Study: NCT03075826

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Right hand MSSA cellulitis
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 2 affected / 22 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Notes: Grade 4
Frequency: 1 affected / 22 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: COVID-19 infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 5
Frequency: 1 affected / 22 at risk

Adverse event: Delirium
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: E.Coli Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 4
Frequency: 1 affected / 22 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 2 affected / 22 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Legionella pnemonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Myositis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Platelet transfusion reaction
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 5
Frequency: 1 affected / 22 at risk

Adverse event: Progression to AML
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 5
Frequency: 1 affected / 22 at risk

Adverse event: Salmonella diarrhea
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Severe anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Splenic pain
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 22 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 4
Frequency: 1 affected / 22 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 22 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1/2
Frequency: 4 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 3 affected / 22 at risk

Adverse event: Appetite change
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 6 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 4 affected / 22 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1/2
Frequency: 5 affected / 22 at risk

Adverse event: Bone/joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1/2
Frequency: 13 affected / 22 at risk

Adverse event: Bruising/bleeds easily
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 5 affected / 22 at risk

Adverse event: Calf cramps/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 3 affected / 22 at risk

Adverse event: Mouth sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1/Grade 2
Frequency: 4 affected / 22 at risk

Adverse event: Chills/rigors
Serious: no
Organ System: General disorders
Notes: Grade 1/2
Frequency: 6 affected / 22 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 2 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1/2
Frequency: 9 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1/2
Frequency: 10 affected / 22 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1/2
Frequency: 8 affected / 22 at risk

Adverse event: Diffuse achiness
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1/2
Frequency: 9 affected / 22 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 1/2/3
Frequency: 10 affected / 22 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 6 affected / 22 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Grade 1/2
Frequency: 2 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1/2/3
Frequency: 15 affected / 22 at risk

Adverse event: Fecal urgency
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1/2
Frequency: 4 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Grade 1/2
Frequency: 6 affected / 22 at risk

Adverse event: Haemangioma
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Bullous haemorrhagic dermatosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1/2
Frequency: 2 affected / 22 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 2 affected / 22 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1/2
Frequency: 4 affected / 22 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1/2
Frequency: 2 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1/2
Frequency: 8 affected / 22 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Notes: Grade 1/2
Frequency: 5 affected / 22 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 2 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1/2
Frequency: 2 affected / 22 at risk

Adverse event: Pallor
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 5 affected / 22 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 3 affected / 22 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1/2
Frequency: 2 affected / 22 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 4 affected / 22 at risk

Adverse event: Progression to AML
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 4 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Grade 1/2
Frequency: 3 affected / 22 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 3 affected / 22 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Grade 1/2
Frequency: 6 affected / 22 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 3 affected / 22 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 2 affected / 22 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 17 affected / 22 at risk