PMID- 19190248 OWN - NLM STAT- MEDLINE DCOM- 20090507 LR - 20220408 IS - 1528-0020 (Electronic) IS - 0006-4971 (Print) IS - 0006-4971 (Linking) VI - 113 IP - 15 DP - 2009 Apr 9 TI - Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. PG - 3604-11 LID - 10.1182/blood-2008-08-175323 [doi] AB - Limited data are available describing donor adverse events (AEs) associated with filgrastim mobilized peripheral blood stem cell (PBSC) collections in unrelated volunteers. We report results in 2408 unrelated PBSC donors prospectively evaluated by the National Marrow Donor Program (NMDP) between 1999 and 2004. Female donors had higher rates of AEs, requiring central line placement more often (17% vs 4%, P< .001), experiencing more apheresis-related AEs (20% vs 7%, P< .001), more bone pain (odds ratio [OR]=1.49), and higher rates of grades II-IV and III-IV CALGB AEs (OR=2.22 and 2.32). Obese donors experienced more bone pain (obese vs normal, OR=1.73) and heavy donors had higher rates of CALGB toxicities (>95 kg vs <70 kg, OR=1.49). Six percent of donors experienced grade III-IV CALGB toxicities and 0.6% experienced toxicities that were considered serious and unexpected. Complete recovery is universal, however, and no late AEs attributable to donation have been identified. In conclusion, PBSC collection in unrelated donors is generally safe, but nearly all donors will experience bone pain, 1 in 4 will have significant headache, nausea, or citrate toxicity, and a small percentage will experience serious short-term adverse events. In addition, women and larger donors are at higher risk for donation-related AEs. FAU - Pulsipher, Michael A AU - Pulsipher MA AD - University of Utah School of Medicine, Primary Children's Hospital, Salt Lake City, UT 84132-2408, USA. michael.pulsipher@hsc.utah.edu FAU - Chitphakdithai, Pintip AU - Chitphakdithai P FAU - Miller, John P AU - Miller JP FAU - Logan, Brent R AU - Logan BR FAU - King, Roberta J AU - King RJ FAU - Rizzo, J Douglas AU - Rizzo JD FAU - Leitman, Susan F AU - Leitman SF FAU - Anderlini, Paolo AU - Anderlini P FAU - Haagenson, Michael D AU - Haagenson MD FAU - Kurian, Seira AU - Kurian S FAU - Klein, John P AU - Klein JP FAU - Horowitz, Mary M AU - Horowitz MM FAU - Confer, Dennis L AU - Confer DL LA - eng GR - U24 CA076518/CA/NCI NIH HHS/United States GR - U24-CA76518/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PT - Research Support, U.S. Gov't, Non-P.H.S. PT - Research Support, U.S. Gov't, P.H.S. DEP - 20090203 PL - United States TA - Blood JT - Blood JID - 7603509 RN - 0 (Recombinant Proteins) RN - 143011-72-7 (Granulocyte Colony-Stimulating Factor) RN - PVI5M0M1GW (Filgrastim) SB - IM MH - Adolescent MH - Adult MH - Age Distribution MH - Blood Cell Count MH - Blood Component Removal/*adverse effects/statistics & numerical data MH - *Blood Donors MH - Fatigue/epidemiology MH - Female MH - Filgrastim MH - Follow-Up Studies MH - Granulocyte Colony-Stimulating Factor/*adverse effects MH - Hematopoietic Stem Cell Mobilization/*adverse effects/statistics & numerical data MH - Hematopoietic Stem Cell Transplantation MH - Humans MH - Incidence MH - Logistic Models MH - Male MH - Middle Aged MH - Obesity/epidemiology MH - Pain/*epidemiology MH - Prospective Studies MH - Recombinant Proteins MH - Risk Factors MH - Sex Distribution MH - Young Adult PMC - PMC2668845 EDAT- 2009/02/05 09:00 MHDA- 2009/05/08 09:00 PMCR- 2009/04/09 CRDT- 2009/02/05 09:00 PHST- 2009/02/05 09:00 [entrez] PHST- 2009/02/05 09:00 [pubmed] PHST- 2009/05/08 09:00 [medline] PHST- 2009/04/09 00:00 [pmc-release] AID - S0006-4971(20)39361-7 [pii] AID - 2008/175323 [pii] AID - 10.1182/blood-2008-08-175323 [doi] PST - ppublish SO - Blood. 2009 Apr 9;113(15):3604-11. doi: 10.1182/blood-2008-08-175323. Epub 2009 Feb 3.