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

NCT ID: NCT06298643

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

177 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-22

Study Completion Date

2025-07-09

Brief Summary

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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.

Detailed Description

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Conditions

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Lower-risk Myelodysplastic Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transfusion dependent

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

Red blood cell transfusion

Intervention Type PROCEDURE

≥2 units of red blood cell transfusion

Non-transfusion dependent

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

Red blood cell transfusion

Intervention Type PROCEDURE

0 units or \<2 units of red blood cell transfusion

Interventions

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Red blood cell transfusion

≥2 units of red blood cell transfusion

Intervention Type PROCEDURE

Red blood cell transfusion

0 units or \<2 units of red blood cell transfusion

Intervention Type PROCEDURE

Eligibility Criteria

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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

* Participants \<18 years of age at index date
* Participants who have a look back period \<30 days from initial myelodysplastic syndrome diagnosis date
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mebix, Inc

Tokyo, Minato-ku, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA056-1094

Identifier Type: -

Identifier Source: org_study_id

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