Study: NCT01456039

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

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood phosphorus increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Long QT syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Biliary colic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 3 at risk

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

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

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 7 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 7 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 7 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 7 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

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

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Electrocardiogram ST-T change
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Electrocardiogram ST-T segment elevation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Renal function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 7 at risk

Adverse event: Carotid arteriosclerosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Henoch-Schonlein purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Infected dermal cyst
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Supraventriclar extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 7 at risk

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

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tumour associated fever
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 7 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Tumour associated fever
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 40 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 40 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 40 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 40 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 40 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 10 affected / 40 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 40 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 40 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 40 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 40 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 40 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 40 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 40 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 40 at risk

Adverse event: Supraventriclar extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 40 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 47 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 47 at risk

Adverse event: Tumour associated fever
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 47 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 47 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 47 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 47 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 47 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 47 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 47 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 47 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 47 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 6 affected / 47 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 47 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 47 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 47 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 47 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 47 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 47 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 47 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 47 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 47 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 47 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 47 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 47 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 47 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 47 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 47 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 47 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 47 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 47 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 47 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 47 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Electrocardiogram ST-T change
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Electrocardiogram ST-T segment elevation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Renal function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 47 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 47 at risk

Adverse event: Carotid arteriosclerosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 47 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Henoch-Schonlein purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 47 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 47 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infected dermal cyst
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 47 at risk

Adverse event: Supraventriclar extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 47 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 47 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 47 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 47 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 47 at risk

Adverse event: Tumour associated fever
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 47 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk