Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Lower-risk Myelodysplastic Syndromes

Treatments: Procedure: Red blood cell transfusion

Study type: Observational

Funder types: Industry

Identifiers

NCT06298643

CA056-1094

Details and patient eligibility

About

The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with at least one definitive myelodysplastic syndrome (MDS) diagnosis as per the 10th Revision of the International Statistical Classification of Diseases and Related Health Problems (MDS; ICD10: D46.X) between 01-May-2017 and 31-Jan-2022

• Participants with confirmed low-risk MDS by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) during baseline as follows:

  • Record of low (0 points) or intermediate-1 (>0 to 1 point) MDS according to IPSS scoring; or
  • Record of very low (≤1.5), low (>1.5-3), or intermediate (>3-4.5) MDS according to IPSS-R scoring; or
  • Mention of very low, low, intermediate, intermediate-1, or lower risk MDS in the Electronic Medical Records (EMR)

• Participants with a record of a confirmed bone marrow procedure (bone marrow aspiration code D404-00 and/or bone marrow biopsy code D404-02) during baseline period

Exclusion criteria

• Participants not meeting the inclusion criteria
• Participants <18 years of age at index date
• Participants who have a look back period <30 days from initial myelodysplastic syndrome diagnosis date

Trial design

177 participants in 2 patient groups

Transfusion dependent

Description:

Participants that received ≥2 units of red blood cell transfusion during the 8 weeks after initial myelodysplastic syndrome diagnosis date.

Treatment:

Procedure: Red blood cell transfusion

Procedure: Red blood cell transfusion

Non-transfusion dependent

Description:

Participants that received 0 units or \<2 units of red blood cell transfusion during the 8 weeks after initial myelodysplastic syndrome diagnosis date.

Treatment:

Procedure: Red blood cell transfusion

Procedure: Red blood cell transfusion