Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea

Celgene

Status: Completed

Conditions: Myelodysplastic Syndrome

Treatments: Drug: Vidaza®

Study type: Observational

Funder types: Industry

Identifiers

NCT02137629

NIPMS-Celgene-KOR-001

Details and patient eligibility

About

The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE is a prospective, multi-centre, observational, non-interventional, post-marketing surveillance. At least 600 patients' data that is eligible for safety assessment will be collected.

VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)

/Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety & efficacy of the drug. It is necessary to examine patients' demographics and baseline characteristics, medical history, status of VIDAZA treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Korean male or female Myelodysplastic Syndrome patients treated with VIDAZA®(subcutaneous or intravenous) according to the approved package insert

Exclusion criteria

• There's no exclusion criteria

Trial design

511 participants in 1 patient group

Korean patients

Description:

All Korean patients intended to be treated with Vidaza® according to the approved package insert

Treatment:

Drug: Vidaza®