Study: NCT01691248

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 300 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 300 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Blindness
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 300 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 300 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 300 at risk

Adverse event: Neutropenic colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 300 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 300 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 300 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 300 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 300 at risk

Adverse event: Engraftment syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Graft versus host disease in gastrointestinal tract
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 300 at risk

Adverse event: Graft versus host disease in skin
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 300 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 300 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 300 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Enterobacter sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Enterococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 300 at risk

Adverse event: Pneumonia cytomegaloviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Pneumonia fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Pseudomonal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 300 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Urinary tract infection enterococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Viral haemorrhagic cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 300 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Product dispensing error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Medication error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Transfusion reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 300 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 300 at risk

Adverse event: Blood albumin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 300 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 300 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 300 at risk

Adverse event: Fluid imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute myeloid leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 300 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Diffuse large B-cell lymphoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Non-Hodgkin's lymphoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Autonomic nervous system imbalance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Autonomic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Leukoencephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 300 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 300 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 300 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Jugular vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 300 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Venoocclusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 300 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 128 affected / 300 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 300 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 300 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 300 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 300 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 300 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 300 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 300 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 300 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 211 affected / 300 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 300 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 300 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 300 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 300 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 184 affected / 300 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 300 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 300 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 300 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 300 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 28 affected / 300 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 117 affected / 300 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 107 affected / 300 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 78 affected / 300 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 69 affected / 300 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 300 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 300 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 300 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 300 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 300 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 97 affected / 300 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 300 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 300 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 300 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 45 affected / 300 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 300 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 300 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 300 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 300 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 300 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 300 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 300 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 300 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 75 affected / 300 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 300 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 300 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 300 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 300 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 300 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 300 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 300 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 300 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 300 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 300 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 300 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 300 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 300 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 300 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 300 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 300 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 300 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 300 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 300 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 300 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 300 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 43 affected / 300 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 300 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 300 at risk

Adverse event: Splenic haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 300 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 300 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Venoocclusive liver disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute graft versus host disease in intestine
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 300 at risk

Adverse event: Acute graft versus host disease in skin
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Engraftment syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Graft versus host disease in gastrointestinal tract
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 300 at risk

Adverse event: Graft versus host disease in lung
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Graft versus host disease in skin
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: BK virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Cellulitis gangrenous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Enterobacter bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Enterococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Escherichia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Human herpesvirus 6 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 300 at risk

Adverse event: Metapneumovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 300 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Pseudomonal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 300 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 300 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 300 at risk

Adverse event: Systemic candida
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Alkalosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute lymphocytic leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Acute myeloid leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Central nervous system lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Peripheral T-cell lymphoma unspecified recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Post transplant lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 300 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 300 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 300 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 300 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 300 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 300 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 98 affected / 300 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 300 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 300 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 300 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 300 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 300 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 300 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 300 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 88 affected / 300 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 220 affected / 300 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 300 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 300 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 300 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 300 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 201 affected / 300 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 300 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 300 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 300 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 300 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 31 affected / 300 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 118 affected / 300 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 106 affected / 300 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 63 affected / 300 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 91 affected / 300 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 300 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 300 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 300 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 300 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 300 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 106 affected / 300 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 300 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 300 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 300 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 300 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 300 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 300 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 300 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 300 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 300 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 300 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 300 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 300 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 87 affected / 300 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 300 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 300 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 300 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 300 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 62 affected / 300 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 300 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 300 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 300 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 300 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 300 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 300 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 300 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 300 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 300 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 300 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 300 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 300 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 300 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 300 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 300 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 300 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 300 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 48 affected / 300 at risk