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Randomization was conducted via a
dedicated Web-based system using
remote data entry, with patients stratified
by donor type and CR status.
Patients were followed for a median
of 27.5 months. Non-relapse mortality at
one year (the study’s primary endpoint,
assessed on an intention-to-treat basis)
was more than doubled in the busulfan
+ cyclophosphamide group compared
with the busulfan + fludarabine group:
17.2 percent (95% CI 11.6-25.4) vs. 7.9
percent (4.3-14.3; p=0.026).
Safety outcomes, assessed in the perprotocol population, were similar but
lower in the patients treated with fludarabine between both groups. The most
frequently reported grade ≥3 treatmentrelated adverse events included:
Table 7: Pe