Trial Information

AZA PH GL 2003 CL 001 - Extension A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)

At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could
be enrolled in an optional extension phase in order to continue treatment with azacitidine
until it became commercially available; the continued treatment was for ethical and safety
reasons only and not to provide additional efficacy data.

During the extension phase, participants were treated based on 28-day cycles and monitored
for hematologic, nonhematologic, and renal toxicities. Recommended monitoring procedures
included complete blood count with differential and platelets at least once each cycle prior
to dosing and as needed, bone marrow biopsy and aspirate as clinically indicated, and
additional tests or more frequent monitoring at the investigator's discretion based on the
patient's clinical status. The azacitidine dose could be modified for toxicities.
Laboratory data were not collected during the extension phase.