Event reported in a literature article: journal of pediatric hematology/oncology 2014; 00:000-000.Accepted for publication 10/03/2014."safety and outcomes of extracorporeal photopheresis with the therakos cellex system for graft-versus-host disease in pediatric patients." a (b)(6), one of four patients (all four with liver involvement) in a retrospective review of twelve pediatric patients that failed to respond to the treatment and died of catheter infection, steroid tapered due to steroid side effects.Hsct indication: all, acute lymphoblastic leukemia donor: mud, matched unrelated donor (9/10).Stem cell: bm, bone marrow.Onset of gvhd (wk): gvhd treatment (pre-ecp): tacr (tacrolimus), mmf (mycophenolate mofetil), mp (methylprednisoline).Interval between onset of gvhd and ecp (wk): 20 gvhd type: overlap (biopsy proven).Affected organs (stage in agvhd, score in cgvhd): chronic skin (3), acute skin (1), acute gis gastriintestinal (2), liver (2).Degree of gvhd: grade 3 acute gvhd, severe chronic gvhd.Improvement: acute: no improvement, chronic: severe to moderate.Ecp procedures: gvhd treatment during ecp: tacr, mmf, mp.Beginning of improvement (if any) (number of procedures): survival: expired.Current status: died of catheter infections, steroid tapered due to steroid side effects.Date of death was not reported.
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No lot number was reported; therefore no batch record review was performed.There were no trends detected for complaint categories, death or multi-organ failure.A (b)(6)male with grade 3 acute gvhd and severe cgvhd of acute lymphoblastic leukemia (all) died of catheter infections, steroids were tapered due to steroid side effects.Patient only had 8 hcp treatments.This case is serious and not related to ecp therapy.Therakos is reporting that out of abundance of caution.Kit unique identifier (udi)#: (b)(4).
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