A Retrospective Observational Cohort Study to Evaluate the Effectiveness of Azacitidine Monotherapy in Treatment-naive Patients With Intermediate, High, and Very High-risk Myelodysplastic Syndrome

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49871
• EU PAS number:
  EUPAS38242
• Study ID:
  49871
• Official title and acronym:
  A Retrospective Observational Cohort Study to Evaluate the Effectiveness of Azacitidine Monotherapy in Treatment-naive Patients With Intermediate, High, and Very High-risk Myelodysplastic Syndrome
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  GS-US-545-5956: The primary objective of this study was to evaluate the effectiveness of azacytidine (AZA)(Vidaza® and other generic versions of Vidaza®) monotherapy as assessed by complete remission (CR) rates defined by the International Working Group (IWG) 2006 myelodysplastic syndrome (MDS) criteria in patients with intermediate, high, and very high-risk MDS.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Study timelines

Date when funding contract was signed

Planned: 02/10/2020

Actual: 02/10/2020

Study start date

Planned: 01/01/2021

Actual: 15/03/2021

Date of final study report

Planned: 30/09/2022

Actual: 30/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

GS-US-545-5956-appendix-16.1.1-protocol_f-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable