Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: VIDAZA® Drug Use Examination
Study ID: NCT02137629
Conditions
Interventions
Study Description
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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Daegu Fatima Hospita, Daegu, , Korea, Republic of
Yeungnam University Medical Center, Daegu, , Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Eulji University Hospital - Daejeon, Daejeon, , Korea, Republic of
Dongguk University Ilsan Hospital, Goyang, , Korea, Republic of
Inje University Ilsan Paik Hospital, Goyang, , Korea, Republic of
National Health Insurance Service Ilsan Hospital, Goyang, , Korea, Republic of
Chosun University Hospital, Gwangju, , Korea, Republic of
Dongguk University Gyeongju Hospital, Gyeongju, , Korea, Republic of
Hwasun Chonnam National University Hospital, Hwasun-gun, , Korea, Republic of
Wonkwang University Hospital, Iksan, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Gacheon University Gil Hospital, Incheon, , Korea, Republic of
Chonbuk National University Hospital, Jeonju, , Korea, Republic of
Gyeongsang National University Hospital, Jinju, , Korea, Republic of
Inje University Seoul Paik Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Kyunghee University Medical Center, Seoul, , Korea, Republic of
Seoul Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea Cancer Center Hospital, Seoul, , Korea, Republic of
Inje University Sanggye Paik Hospital, Seoul, , Korea, Republic of
Konkuk University Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Boramae Medical Center, Seoul, , Korea, Republic of
Chung-ang University Hospital, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, St. Vicent's Hospital, Suwon, , Korea, Republic of
Ajou University Medical Center, Suwon, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Contact Details
Name: Miran Moon
Affiliation: Clinical Research Manager, Celgene Korea
Role: STUDY_DIRECTOR
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