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The New England journal of medicine, 2005-02, Vol.352 (5), p.511-512
Ort / Verlag
United States: Massachusetts Medical Society
Erscheinungsjahr
2005
Quelle
MEDLINE
Beschreibungen/Notizen
To the Editor:
Bennett et al. (Sept. 30 issue)
1
calculated the “incidence” of pure red-cell aplasia among patients receiving epoetin therapy by reviewing reports from the Adverse Event Reporting System of the Food and Drug Administration (FDA). The calculation of incidence rates of pure red-cell aplasia requires complete ascertainment of new cases of this condition in a defined population at risk per unit of time. The completeness of case ascertainment when the FDA's system is used is usually low because that system is based on passive reporting. In addition, some of the 208 cases lacking antibody data and excluded by . . .