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

• 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 institutions 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

Regulatory

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