Study: NCT02692248

Adverse event: Diarrhoea - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Fever - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Abdominal pain - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Akathisia - Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Anemia - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Back Pain - Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Confusion - Grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Diarrhoea - Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Dysphagia - Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Fatigue - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Febrile neutropenia - Grade 2
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Febrile neutropenia - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Fever - Grade 1
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Fever - Grade 2
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Flu like symptoms - Grade 2
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Fracture - Grade 3
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 64 at risk

Adverse event: Gastroenteritis - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Clinical deterioration - Grade 5
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Heart failure - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hematoma - Grade 2
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hip fracture Grade 3
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Hypotension - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Herpes zoster - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Candidiasis - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Patient took expired medication - GradeUK
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Lung infection - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Lung infection - Grade 5
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Malaise - Grade 5
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Renal tumor - Grade 4
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 64 at risk

Adverse event: Pain - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pericardial tamponade - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pericarditis - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pleural effusion - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Respiratory failure - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Respiratory failure - Grade 5
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Partial respiratory failure-Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Sepsis - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Septic shock - Grade 5
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Transient ischemic attacks - Grade 2
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Tumor lysis syndrome - Grade 4
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 64 at risk

Adverse event: Upper respiratory infection - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Upper respiratory infection - Grade 5
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Urinary tract infection - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Urinary tract infection - Grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Subarachnoid hemorrhage - Grade 2
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 64 at risk

Adverse event: Vomiting - Grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Vomiting - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 64 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 64 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 14 affected / 64 at risk

Adverse event: Lymphocyte count decrease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 64 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 64 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 64 at risk