Study: NCT01518517

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 26 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Febrile bone marrow aplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 26 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 26 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 26 at risk

Adverse event: Graft versus host disease
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Allergic transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 26 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 26 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 26 at risk

Adverse event: Antithrombin III decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 26 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 26 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 26 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 26 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 26 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 26 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 26 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 26 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 26 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 26 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 26 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 26 at risk

Adverse event: Febrile bone marrow aplasia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Hypofibrinogenaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 26 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 28 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 28 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Febrile bone marrow aplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 28 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 28 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 28 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 28 at risk

Adverse event: Graft versus host disease
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: Allergic transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 28 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 28 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 28 at risk

Adverse event: Antithrombin III decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 28 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 28 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 28 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 28 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Prothrombin level decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 28 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 28 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 28 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 28 at risk

Adverse event: Febrile bone marrow aplasia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 28 at risk

Adverse event: Hypofibrinogenaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 28 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 28 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 28 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 26 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Febrile bone marrow aplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 26 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Fusarium infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Human herpesvirus 6 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 17 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Allergic transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 26 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 26 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 26 at risk

Adverse event: Antithrombin III decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 26 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 26 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 26 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 26 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 26 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 26 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 5 affected / 26 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 26 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 26 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 26 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 26 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 26 at risk

Adverse event: Febrile bone marrow aplasia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 26 at risk

Adverse event: Hypofibrinogenaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 26 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 26 at risk

Adverse event: Cholestasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk