Data Collection

Data collection began at the time of the donor’s medical evaluation to determine suitability to donate hematopoietic stem cells and continued throughout the time of donation and long term as described below. Both marrow and PBSC donors were contacted by the donor center at 2 days after donation, then at 1 week, and weekly thereafter until complete recovery. “Complete recovery” was judged by the donor center coordinator or medical director based on reports of return to baseline and no ongoing symptoms associated with the collection procedure as ascertained by the weekly follow up call with the donor. Further contact with the donor occurred at 1 month, 6 months, and annually to assess for the presence of any new or residual symptoms. Detailed questions using the toxicity criteria modeled on National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) were used to assess specific symptoms commonly associated with donation (see endpoints below for list of symptoms) and to capture any toxicity the donor may have experienced as a result of the hematopoietic stem cell donation process. In addition, a complete blood count and white cell differential were performed at the initial medical evaluation, on the first day of G-CSF, the day(s) of collection, and, for some donors, at annual follow-ups.