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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

NCT02137629 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 511

Last updated 2019-11-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Vidaza®

The recommended starting dose for the first treatment for all patients regardless of baseline hematology values is Vidaza® 75mg/m2 subcutaneous(SC) injection or intravenous (IV) infusion, daily for 7 days.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Miran Moon · Clinical Research Manager, Celgene Korea

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-27
Primary Completion
2016-05-19
Completion
2016-05-19

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137629 on ClinicalTrials.gov