Study: NCT00301834

Adverse event: aGVHD (acute Graft-Versus-Host Disease)
Serious: yes
Organ System: General disorders
Notes: acute Graft-Versus-Host Disease
Frequency: 1 affected / 35 at risk

Adverse event: Respiratory distress associated with Cytomegalovirus infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: After 4th unrelated donor transplant (off study), patient developed respiratory distress that was associated with a CMV infection. Respiratory distress worsened in spite of maximal therapy. The parents elected to withdraw therapy and he died.
Frequency: 1 affected / 35 at risk

Adverse event: Pancytopenia and splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Child presented with fever and pancytopenia, splenomegaly and was admitted for possible recurrent disease.
Frequency: 1 affected / 35 at risk

Adverse event: Repiratory failure following ideopathic pneumonia syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Worsening respiratory status despite maximal support, at parent's request, patient was removed from mechanical ventilation, and the patient died quickly and peacefully.
Frequency: 1 affected / 35 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Sudden onset of thrombocytopenia of unknown etiology.
Frequency: 1 affected / 35 at risk

Adverse event: Aspergillus pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Patient admitted with cough and fever and diagnosed with Aspergillus pneumonia.
Frequency: 1 affected / 35 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient developed renal failure and is required dialysis
Frequency: 1 affected / 35 at risk

Adverse event: Graft rejection/failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: initially, cells recovered normally with neutrophil count \>500 by day +12 post-transplant. By day +20 they began a slow decline and by day +40 the neutrophil count was \<500 with 99% host CD3+ (cluster of differentiation 3-positive) cells.
Frequency: 1 affected / 35 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Massive intracranial bleed
Serious: yes
Organ System: Vascular disorders
Notes: Child died from a massive intracranial bleed, probably due to Evan's syndrome and myeloablation; possible viral encephalitis possibly increased risk of intracranial hemorrhage.
Frequency: 1 affected / 35 at risk

Adverse event: Mucositis (All grades)
Serious: no
Organ System: Gastrointestinal disorders
Notes: \< Grade III - 17 participants; Grade III - 15 participants; Grade IV - 1 participant
Frequency: 33 affected / 35 at risk

Adverse event: Acute graft versus host disease
Serious: no
Organ System: General disorders
Notes: aGVHD \< Grade IV
Frequency: 5 affected / 35 at risk

Adverse event: cGVHD (Chronic graft-versus-host disease)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Infusion reaction to alemtuzumab
Serious: no
Organ System: General disorders
Frequency: 19 affected / 35 at risk