The specified drug use result surveillance of darbepoetin alfa, study on anemia associated with myelodysplastic syndromes

The specified drug use result surveillance of darbepoetin alfa, study on anemia associated with myelodysplastic syndromes - The specified drug use result surveillance of darbepoetin alfa

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056049

Enrollment

600

Registered

2024-11-05

Start date

2015-02-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia associated with myelodysplastic syndromes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have anemia associated with myelodysplastic syndromes and were treated with darbepoetin alfa.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
1. Safety (1) Occurrence of ADRs and infection (2) Evaluation on factors likely to affect safety (3) Occurrence of unknown ADRs (4) Occurrence of serious AEs (5) Occurrence of priority survey items (effect on transition to AML and life prognosis) 2. Efficacy (1) Overall improvement level (by attending physicians) (2) Changes in Hb level (3) Evaluation on factors likely to affect efficacy	—

Countries

Japan

Contacts

Public ContactYukie Tsuji

Kyowa Kirin Co.,Ltd. Pharmacovigilance division

yukie.tsuji.dq@kyowakirin.com03-5205-7200

Outcome results