Phase 3
Completed N=40
An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)
Source: ClinicalTrials.gov NCT01186939 ↗Enrolled (actual)
40
Serious AEs
50.0%
Results posted
Sep 2010
Primary outcomePrimary: Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period — 39; 27; 20; 5 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period |
39; 27; 20; 5; 15; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Participants were considered eligible if they had been randomized to azacitidine treatment in the primary study and were receiving azacitidine at the time of study closure, had completed 12 months of treatment and observation in the primary study, and had signed the informed consent document for the extension phase of the study.
- See study: AZA PH GL 2003 CL 001 for a list of inclusion criteria for the primary study.
Exclusion Criteria
- None specific to the extension phase of the study
- See study: AZA PH GL 2003 CL 001 for a list of exclusion criteria for the primary study.
Data sourced from ClinicalTrials.gov (NCT01186939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.