NCT02137629

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

VIDAZA® Drug Use Examination

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 511 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-12-27
• Primary completion: 2016-05-19
• Completion: 2016-05-19
• First posted: 2014-05-14
• Last updated: 2019-11-18

Locations

48 sites across 1 country: South Korea