Study: NCT00597714

Adverse event: Supraventricular and nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 80 at risk

Adverse event: Death - NOS
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 80 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hepatobiliary/Pancreas
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Elevation bilirubin and alkaline phosphate
Frequency: 1 affected / 80 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Notes: Meningitis; Parainfluenza; Herpes Zoster; Nocardia; Sepsis; Hickman line infection; C-Diff
Frequency: 3 affected / 80 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis; Parainfluenza III; Gram positive cocci (Staph Aureus); Human Herpes Virus 6; Pneumonia; Polyoma virus; Viremia
Frequency: 2 affected / 80 at risk

Adverse event: Infection with grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
Serious: yes
Organ System: Infections and infestations
Notes: H. pylori; BK virus; Influenza
Frequency: 2 affected / 80 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Notes: Fever possibly due to Human Herpes Virus 6
Frequency: 1 affected / 80 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Death
Frequency: 1 affected / 80 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of Breath
Frequency: 1 affected / 80 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Failure to Engraft
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 80 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 80 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Hemorrhage/Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Liver laceration; Retroperitoneal bleed; Ulcerative Colitis; Death (4)
Frequency: 5 affected / 80 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 80 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Notes: Pneumonia; Sepsis; Viremia; Human Herpes Virus 6; Herpes Simplex Virus; Cytomegalovirus; Fungal Pneumonia
Frequency: 14 affected / 80 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
Serious: no
Organ System: Infections and infestations
Notes: Bacteremia; Polyoma; Cytomegalovirus; Viremia; Varicella Zoster; Human Herpes Virus 6; Parainfluenza; Respiratory syncytial virus; Penicillium; Vancomycin-resistant enterococcus; Nocardia; Strep Viridans; Gram+ cocci; Ecoli; C-Diff; Klebsiella; MRSA
Frequency: 53 affected / 80 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Varicella Zoster; Cytomegalovirus; Viremia; Pneumonia; Stenotrophomonas Maltophilin; Herpes Simplex Virus; Human Herpes Virus 6; Gram+ cocci; Polyoma; Respiratory syncytial virus; C-Diff; Rhizopus; Parainfluenza; BK virus; Staph; MRSA; Gram- rod
Frequency: 42 affected / 80 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Thrush; Polyoma; Gram negative Sepsis; Gram positive cocci; Cytomegalovirus; Human Herpes Virus 6; Parainfluenza
Frequency: 5 affected / 80 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 80 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of Breath
Frequency: 7 affected / 80 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: Polyoma nephritis; Dysuria; Foscarnet urethritis; Hematuria; Renal Insufficiency; Renal Failure (3)
Frequency: 7 affected / 80 at risk

Adverse event: Cardiac Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Death - NOS
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 57 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Notes: Meningitis; Parainfluenza; Herpes Zoster; Nocardia; Sepsis; Hickman line infection; C-Diff
Frequency: 3 affected / 57 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis; Parainfluenza III; Gram positive cocci (Staph Aureus); Human Herpes Virus 6; Pneumonia; Polyoma virus; Viremia
Frequency: 3 affected / 57 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: CNS - Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Central Nervous System
Frequency: 1 affected / 57 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Portal hypertension
Frequency: 1 affected / 57 at risk

Adverse event: Failure to Engraft
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 57 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Hemorrhage/Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Liver laceration; Retroperitoneal bleed; Ulcerative Colitis; Death (4)
Frequency: 3 affected / 57 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 57 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Notes: Pneumonia; Sepsis; Viremia; Human Herpes Virus 6; Herpes Simplex Virus; Cytomegalovirus; Fungal Pneumonia
Frequency: 4 affected / 57 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
Serious: no
Organ System: Infections and infestations
Notes: Bacteremia; Polyoma; Cytomegalovirus; Viremia; Varicella Zoster; Human Herpes Virus 6; Parainfluenza; Respiratory syncytial virus; Penicillium; Vancomycin-resistant enterococcus; Nocardia; Strep Viridans; Gram+ cocci; Ecoli; C-Diff; Klebsiella; MRSA
Frequency: 41 affected / 57 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Varicella Zoster; Cytomegalovirus; Viremia; Pneumonia; Stenotrophomonas Maltophilin; Herpes Simplex Virus; Human Herpes Virus 6; Gram+ cocci; Polyoma; Respiratory syncytial virus; C-Diff; Rhizopus; Parainfluenza; BK virus; Staph; MRSA; Gram- rod
Frequency: 18 affected / 57 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Thrush; Polyoma; Gram negative Sepsis; Gram positive cocci; Cytomegalovirus; Human Herpes Virus 6; Parainfluenza
Frequency: 1 affected / 57 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of Breath
Frequency: 1 affected / 57 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: Polyoma nephritis; Dysuria; Foscarnet urethritis; Hematuria; Renal Insufficiency; Renal Failure (3)
Frequency: 2 affected / 57 at risk