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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period
Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption.
43- 68 months
United States: Food and Drug Administration
AZA PH GL 2003 CL 001 E