Study: NCT00968864

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 52 at risk

Adverse event: HHV-6 Reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 52 at risk

Adverse event: Graft vs. Host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 9 affected / 52 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 52 at risk

Adverse event: Acute gastroenteritis/ diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: CMV reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: EBV-related lymphoproliferative disease
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: Infection w/ unknown absolute neutrophil count (ANC)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 52 at risk

Adverse event: Relapse
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 26 at risk

Adverse event: Decreasing donor chimerism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 52 at risk

Adverse event: Infection - grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 52 at risk

Adverse event: Viral upper respiratory infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Renal & Urinary disorder - grade 3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pneumoatosis Intestinalis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Mucositis/ dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Leukopenia/ Neutropenia - grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pulmonary/ Upper Respiratory- other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Blood tinged sputum, following fungal pneumonia
Frequency: 1 affected / 52 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Infection - eye
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Dehydration with hypernatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypoxia - grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 52 at risk

Adverse event: Rash - grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 52 at risk

Adverse event: Seizures - grade 3
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 52 at risk

Adverse event: Hypokalemia - grade 4
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 52 at risk

Adverse event: Hypoxia - grade 4
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Renal and Urinary disorder - grade 3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 52 at risk

Adverse event: Thrombotic microangiopathy - grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 52 at risk

Adverse event: Thrombotic microangiopathy - grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 52 at risk

Adverse event: Elevated ALT - grade 4
Serious: no
Organ System: Investigations
Frequency: 3 affected / 52 at risk

Adverse event: Hypertension - grade 4
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 52 at risk

Adverse event: Idiopathic pneumonia syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Renal disorder - grade 4
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 52 at risk

Adverse event: Thrombosis - grade 3 (catheter-related)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 52 at risk