Study: NCT00586703

Adverse event: Failure to Engraft
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Supraventricular and nodal arrhythmia
Frequency: 1 affected / 16 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Supraventricular and nodal arrhythmia
Frequency: 1 affected / 16 at risk

Adverse event: Dermatology - Skin (other)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Squamous cell carcinoma - left chest
Frequency: 1 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: desquamation - contact dermatitis on neck and face
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: ulcerative esophagitis
Frequency: 1 affected / 16 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hemorrhage - GU
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C
Frequency: 2 affected / 16 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Notes: Cytomegalovirus Retinitis
Frequency: 1 affected / 16 at risk

Adverse event: Infection-bacterial with grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
Serious: no
Organ System: Infections and infestations
Notes: C-diff; Gram-rod bacteria; Methicillin-resistant Staphylococcus aureus (MRSA); Klebsiella; E-coli; Bacillus and Coag Negative Staph
Frequency: 5 affected / 16 at risk

Adverse event: Infection-bacterial with normal ANC or grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Osteomyelitis; Pseudomonas bacteremia; Staph; Enterococcus
Frequency: 3 affected / 16 at risk

Adverse event: Infection-viral without febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Cytomegalovirus; Viremia; Parainfluenza
Frequency: 3 affected / 16 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: AST; SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Aspartate transaminase; serum glutamic oxaloacetic transaminase
Frequency: 1 affected / 16 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 4.3 mg/dl
Frequency: 1 affected / 16 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Motor neuropathy
Frequency: 1 affected / 16 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Secondary Malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Post-transplant lymphoproliferative disorder
Frequency: 1 affected / 16 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Blood/Bone Marrow - Blast Crisis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Relapsed Acute myeloid leukemia
Frequency: 1 affected / 16 at risk

Adverse event: Infection-viral with normal ANC or grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Cytomegalovirus; Viremia; Polyoma; Herpes; Varicella Zoster
Frequency: 5 affected / 16 at risk

Adverse event: Infection-viral with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
Serious: no
Organ System: Infections and infestations
Notes: Adenovirus; Cytomegalovirus; Parainfluenza; Polyoma; Human Herpes Virus 6; Viremia
Frequency: 7 affected / 16 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection-bacterial without febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Gram positive Cocci bacteria
Frequency: 1 affected / 16 at risk