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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean patients | All Korean patients intended to be treated with Vidaza® according to the approved package insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vidaza® | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Adverse Events (AE) | 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:
| Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Number of patients with response (CR, PR, mCR) based on the International Working Group (IWG 2006) response criteria for Myelodysplastic Syndrome (MDS) | Up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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All Korean patients who are intended to be treated with VIDAZA® according to the approved package insert
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| Name | Affiliation | Role |
|---|---|---|
| Miran Moon | Clinical Research Manager, Celgene Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | 431-796 | South Korea | |||
| Soon Chun Hyang University Hospital Bucheon |
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| Bucheon-si |
| 420-853 |
| South Korea |
| Kosin University Gospel Hospital | Busan | 602-030 | South Korea |
| Dong-a University Medical Center | Busan | 602-715 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Inje University Busan Paik Hospital | Busan | 614-735 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 614-735 | South Korea |
| Dongnam Inst. of Radiological & Medical Science | Busan | 619-953 | South Korea |
| Soon Chun Hyang University Hospital Cheonan | Cheonan | 330-721 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | 138-736 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 700-712 | South Korea |
| Kyungpook National University Hospital | Daegu | 700-712 | South Korea |
| Daegu Fatima Hospita | Daegu | 701-010 | South Korea |
| Yeungnam University Medical Center | Daegu | 705-030 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 705-034 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| Eulji University Hospital - Daejeon | Daejeon | 302-799 | South Korea |
| Dongguk University Ilsan Hospital | Goyang | 410-773 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang | 411-706 | South Korea |
| National Health Insurance Service Ilsan Hospital | Goyang | 411-719 | South Korea |
| Chosun University Hospital | Gwangju | 501-717 | South Korea |
| Dongguk University Gyeongju Hospital | Gyeongju | 780-350 | South Korea |
| Hwasun Chonnam National University Hospital | Hwasun-gun | 519-809 | South Korea |
| Wonkwang University Hospital | Iksan | 570-711 | South Korea |
| Inha University Hospital | Incheon | 400-711 | South Korea |
| Gacheon University Gil Hospital | Incheon | 405-760 | South Korea |
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
| Gyeongsang National University Hospital | Jinju | 660-702 | South Korea |
| Inje University Seoul Paik Hospital | Seoul | 100-032 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Severance Hospital | Seoul | 120-752 | South Korea |
| Kyunghee University Medical Center | Seoul | 130-702 | South Korea |
| Seoul Medical Center | Seoul | 131-865 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Seoul National University Hospital | Seoul | 135-710 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Korea Cancer Center Hospital | Seoul | 139-706 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | 139-707 | South Korea |
| Konkuk University Hospital | Seoul | 143-729 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Boramae Medical Center | Seoul | 156-707 | South Korea |
| Chung-ang University Hospital | Seoul | 156-755 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 158-710 | South Korea |
| The Catholic University of Korea, St. Vicent's Hospital | Suwon | 442-723 | South Korea |
| Ajou University Medical Center | Suwon | 443-721 | South Korea |
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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