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

Completed

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: Vidaza®

• Registration Number: NCT02137629
• Lead Sponsor: Celgene

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2016-05-19
• Study Completion: 2016-05-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients with Adverse Events (AE)	Up to 6 years	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.; An SAE is any event that: * is fatal or life threatening; * results in persistent or significant disability or or incapacity; * requires or prolongs existing hospitalization; * is a congenital anomaly/birth defect in the offspring of a patient who received medication; * conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 24 weeks	Number of patients with response (CR, PR, mCR) based on the International Working Group (IWG 2006) response criteria for Myelodysplastic Syndrome (MDS)

Trial Locations

Locations (47)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Dong-a University Medical Center; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Dongnam Inst. of Radiological & Medical Science; 🇰🇷 Busan, Korea, Republic of

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of

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